chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intervertebral disc disorder, Magnetic resonance imaging, Musculoskeletal chest pain, Pelvic pain, Spinal X-ray abnormal
Clinical narrative: She got her vaccine, sat her down for about 15-20 minutes, that's when she would say about 9 years later she felt something crawling down towards her rib cage and towards her spine.  She told the nurse and she was informed that it was normal, it was her lymph glands.  Then during the night she felt that in her back and rib cage traveling pain like soreness, and this is what she still feels.  Once in a while she gets a little jolt in the back by her spine or the rib cage, and the pain travels to the front, stomach and pelvis.  It then hits her bottom and the pain does not let her sleep and has gone from bed, to chair.  She also has had loss of appetite and has lost 21# since December and still loosing as she can hardly eat.  She is a small person and has no fat muscle left and looks like bariatric looking.  She went to her doctor who did MRI's, x-rays of her back and this showed some discs are touching each other and has degenerative disc disease and the pain is unbearable.  Then she got blood work done which showed the antibodies were 2500.  She was given Prednisone at the beginning when she saw him 2 weeks ago which made her constipation, which she does not have.  She called him and told her that she did not want to take it, then went back to it because the pain was unbearable.  He also gave her nausea medicine, and also gave her Tramadol to sleep, which does not help much.  She was okay before she got the booster vaccine.    She did not have any problems with the first two vaccines that she got.    She now suffers from severe pain and is crying as she is talking to me, and does not know what she will do and continues to loose weight.    She just wants to get back to herself, and get her appetite back.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: She got her vaccine, sat her down for about 15-20 minutes, that's when she would say about 9 years later she felt something crawling down towards her rib cage and towards her spine.  She told the nurse and she was informed that it was normal, it was her lymph glands.  Then during the night she felt that in her back and rib cage traveling pain like soreness, and this is what she still feels.  Once in a while she gets a little jolt in the back by her spine or the rib cage, and the pain travels to the front, stomach and pelvis.  It then hits her bottom and the pain does not let her sleep and has gone from bed, to chair.  She also has had loss of appetite and has lost 21# since December and still loosing as she can hardly eat.  She is a small person and has no fat muscle left and looks like bariatric looking.  She went to her doctor who did MRI's, x-rays of her back and this showed some discs are touching each other and has degenerative disc disease and the pain is unbearable.  Then she got blood work done which showed the antibodies were 2500.  She was given Prednisone at the beginning when she saw him 2 weeks ago which made her constipation, which she does not have.  She called him and told her that she did not want to take it, then went back to it because the pain was unbearable.  He also gave her nausea medicine, and also gave her Tramadol to sleep, which does not help much.  She was okay before she got the booster vaccine.    She did not have any problems with the first two vaccines that she got.    She now suffers from severe pain and is crying as she is talking to me, and does not know what she will do and continues to loose weight.    She just wants to get back to herself, and get her appetite back.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered with an expired dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered with an expired dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered with an expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered with an expired dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was not known. The vial Didn't undergo any temperature excursions. No Concomitant Medications were provided by the Reporter. No Treatment Medications were provided by the Reporter   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: No New information.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administration of improperly stored vaccine; This spontaneous report was received from a registered nurse referring to a 10 years old female patient. There were no concomitant medications, concurrent conditions, medical history or drug reactions/allergies reported. There were no other vaccines within 4 weeks prior to the vaccine administration.  On 18-MAR-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) which was improperly stored, 0.5 milliliter once in the right deltoid (strength and route not reported, lot # u008316, expiration date: 15-AUG-2023) for prophylaxis (product storage error). There was no illness at time of vaccination. The operator was fully trained, followed all direction and administration was cleared. The temperature excursion occurred when there was a unit malfunction, and the refrigerator worked out of range for 20 minutes or less before the vaccine was moved to a different unit that was in range. All vaccines were cleared as viable, no issues, no harm reached the patient. All vaccines were cleared for use. No measures need to be taken. The refrigerator was replaced. No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; improperly stored GARDASIL 9 was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported.  On 31-JAN-2022, the patient was vaccinated with one dose of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose and route not reported, lot # T039467, expiration date: 20-MAY-2023) for prophylaxis (product storage error). The vaccine was exposed to temperature 33.4 degrees Fahrenheit (F) for a time frame of 2595 hours. There was no previous temperature excursion. No other adverse event was reported.  This is one of the several reports from the same reporter. ; Sender's Comments:  US-009507513-2203USA007997: US-009507513-2203USA007825: US-009507513-2203USA007812: US-009507513-2203USA008053: US-009507513-2203USA008063: US-009507513-2203USA008097:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored PEDVAXHIB;; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reaction/allergies were not reported.   On 21-FEB-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported; lot # U024089, expiration date: 27-OCT-2023) for prophylaxis (product storage error).    It was reported that the suspect vaccine was exposed to a temperature of minus 59.0 Fahrenheit (F) for a time frame of 2 hours and 47 minutes (the temperature excursion occurred on 19-FEB-2022). There were no previous temperature excursions.   No additional adverse event (AE) information was provided (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 31-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 01-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U029319, expiration date: 19-MAR-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 05-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: sick; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and general body pain. On an unknown date, the outcome of the sickness, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the sickness, fever and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingles vaccine and felt sick with fever and body aches for a week. The patient asked what could he/she do to help with the symptoms. The reporter did not consent to follow-up. Additional supportive information: This case was reported by a consumer via digital media.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1st shingles shot, it didn't have much affect; 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.   The patient's past medical history included shingles (had shingles 6 times).   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 shingles. The patient was treated with acyclovir (Zovirax) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had shingles 6 times, pain pills the only relief. The patient received dose of Shingles vaccine but it didn't have much affect but he/she kept a prescription of Zoverex or Valtrex on hand all the time. The patient stated that the shingle virus must be treated by one of these two (Zoverex or Valtrex) within the first 3 to 4 days or it could affect your nerve roots. The patient also stated that the shingles medical name was Herpes Zoster. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had only a sore arm; 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 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: 8-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and had only a sore arm from the shot. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he did not get dose 2 yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 14th September 2021 into left arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The patient's wife reported this case. The patient did not have any side effects after first dose but he did not get dose 2 yet. They were aware he should have gotten it between 2-6 months after dose 1. The reporter did not want to file adverse event or provided patient's information education provided per content. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case has been linked with case US2022063353, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022063353:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comment: The patient self-reported this case via digital media.. The patient received dose of Shingrix vaccine and experienced allergic reaction. The patient stated that GlaxoSmithKline should provide consumers with a sample of Shingrix so they could get an allergy test before they get the shot.  How else would anyone knew that they were allergic, GlaxoSmithKline was careless in this regard. The patient asked where could a consumer got an allergy treatment about Shingrix. The patient did not want to get Shingrix never again. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: the 2nd dose kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date (didn't have much of a reaction with the first one)).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt it kicked her buttock. The patient stated that hope the second wasn't so bad. Additional supportive information: The follow-up would not possible, as no contact details were available. This case is linked to the case US2022AMR064636, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064636:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: the 2nd dose kicked my Husband's butt; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: This case was received from social media page. This case was reported for the patient's husband. The patient did not have much of a reaction with the first one but the second one kicked butt. The reporter hoped the second was not so bad for other. Additional Supportive Information: This case was linked with case US2022AMR064629, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064629:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: got 2nd shot hurts like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-Apr-2022 Reporter's comments: This case was received from social media page. The patient just got 2nd shot of shingles vaccine and it was hurt like hell but the patient was sure nothing compared to having shingles. The patient's pharmacist said that the 2 shot shingle series was somewhere near 98 percent effective. The patient had insurance and did not pay for the shots. The patient got them at the pharmacy. The patients know the friends that gotten shingles and had a horrific time. The patient did not want it. The pharmacist said that it was very effective at preventing another breakout if you previously had shingles. So everyone need to got it.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nephrolithiasis, Renal colic, Vaccination failure
Clinical narrative: shingles, vaccine made it less severe/suspected vaccination failure; kidney stone; shingles on face and mouth; Kindney stone pain; 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), renal stone (serious criteria GSK medically significant), shingles and renal colic. On an unknown date, the outcome of the vaccination failure, renal stone and renal colic were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, renal stone, shingles and renal colic to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had the shingles vaccine and it might have made shingles less severe for him/her. The patient just recovered from shingles on his/her face and mouth. A place that didn't require clothes rubbing against shingles. Personally he/she thought pain from a kidney stone was worse. 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. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: raised rash at the injection site; injection site was hot; injection site was painful; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced injection site rash, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site warmth and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix in her right upper arm and experienced a raised rash at the injection site, and the injection site was hot and painful. The patient inquired how long it would take for symptoms to subside and if she could take Benedryl. Additional supportive information:  The patient disconnected the call and agent was unable to obtain further adverse event information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Surgery, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: Pt got vx, had breakthrough infection of shingles/Suspected vaccination failure; Breakthrough Infection of Shingles; Nerve damage; Surgery; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and surgery. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage and surgery were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The reporter considered the nerve damage and surgery to be unrelated to Shingrix.  Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's Comment: The case was reported by the patient. The patient had a breakthrough infection of shingles that was precipitated by surgery and nerve damage. The patient had surgery and nerve damage not due to shingles. The reporter consented to follow up. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. 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.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Newborn boy (2 hours of life) received by error a shot; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 11th April 2022, the patient received Boostrix. On 11th April 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 11-Apr-2022 Reporter's comment:  The reporter reported that a newborn patient (2 hours of life) received a dose of Boostrix by error. No reactions were noted. The reporter consented to follow up via email. Additional Supportive Information: A newborn patient received a dose of Boostrix by error, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix lyophilized vial was reconstituted with sterile water; Shingrix lyophilized vial was reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution 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 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: 11-APR-2022 Reporter's comment: The pharmacist inquired regarding Shingrix dosage. Shingrix lyophilized vial was reconstituted with sterile water. The pharmacist was unsure if the Shingrix lyophilized vial was reconstituted with unknown diluent and administered or if the vial was just missing.  The RPH (Registered pharmacist) was unable to provide any details of vaccine or if any patient was involved. The reporter did not consent to follow up. Additional Supportive Information: The patient received Shingrix which was diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error, Medication error, Product prescribing error
Clinical narrative: they plan to administer Hiberix to a 37 year old patient; Circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 37-year-old male patient who received Hib (Hiberix) (batch number EN2Y7, expiry date 1st April 2023) for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient did not receive Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced drug prescribing error and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug prescribing error and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK receipt date: 12-Apr-2022 Reporter's comment: Pharmacist called in to inquired and report about any information over the age of 4 years for Hiberix. The reporter stated they had planned to administer Hiberix to a 37 year old patient on date of reporting (12th April 2022) who had a splenectomy. The reporter asked that it could be administered. Did not consent to follow-up. Additional Supportive Information: The pharmacist planned to administer Hiberix to a 37 year old patient on date of reporting, which led to drug prescribing error and circumstance or information capable of leading to medication error.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).; 2nd Primary shot: On MAR2021, First Booster dose on Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary shot: On MAR2021, First Booster dose on Aug2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary shot: On MAR2021, First Booster dose on Aug2021). At the time of the report, ACCIDENTAL OVERDOSE (Received full dose as the first booster/received the first booster of Moderna COVID-19 vaccine, but they gave her more than the approved dose, (Full dose).) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Primary shot: On MAR2021, First Booster dose on Aug2021) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red spots from left elbow to wrist, red spots ongoing for 6 months; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots from left elbow to wrist, red spots ongoing for 6 months) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 013M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (Recent change in status such as improvement or worsening: No change reported), Immunocompromised (due to white blood count lower than average), White blood cell count low (Paitent is immunocompromised due to white blood count lower than average) and Thyroid disorder. Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In October 2021, the patient experienced RASH MACULAR (red spots from left elbow to wrist, red spots ongoing for 6 months). The patient was treated with TRIAMCINOLONE for Red spotty rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (red spots from left elbow to wrist, red spots ongoing for 6 months) had not resolved.            Concomitant medications also included thyroid medication and hormone replacement therapy.  It had been stated that the dermatologist did not make any diagnoses of the red spots. It had been reported that symptom worsened. The reporter stated that the red spots were not itchy and not raised on the skin. It was also reported that the patient did not have any reactions to the first and second Moderna primary series doses but the reporter believed that the patient had a reaction to the Moderna booster doses. .   This case was linked to MOD-2022-538964 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccines; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccines) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow up received contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: She felt lousy for 2-3 days but got better after that.; She had a fever of 102 F for a day, after which it dropped down to 100 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039K20A) for COVID-19 vaccination.     Patient did not had a COVID positive test or diagnosis. Patient had no other vaccines given within one month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Demerol) and Latex allergy (Latex sensitivity). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F). On 05-Feb-2021, FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever of 102°F for a day, after which it dropped down to 100°F. and 100 (High) fever of 102°F for a day, after which it dropped down to 100°F..         No treatment information was provided.   This case was linked to MOD-2022-539493 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Epicondylitis, Fatigue, Malaise, Paraesthesia
Clinical narrative: She felt lousy for 2-3 days but got better after that.; She had a fever of 102 F for a day, after which it dropped down to 100 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039K20A) for COVID-19 vaccination.     Patient did not had a COVID positive test or diagnosis. Patient had no other vaccines given within one month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Demerol) and Latex allergy (Latex sensitivity). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F). On 05-Feb-2021, FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever of 102°F for a day, after which it dropped down to 100°F. and 100 (High) fever of 102°F for a day, after which it dropped down to 100°F..         No treatment information was provided.   This case was linked to MOD-2022-539493 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tendon pain, Tendonitis
Clinical narrative: She felt lousy for 2-3 days but got better after that.; She had a fever of 102 F for a day, after which it dropped down to 100 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039K20A) for COVID-19 vaccination.     Patient did not had a COVID positive test or diagnosis. Patient had no other vaccines given within one month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Demerol) and Latex allergy (Latex sensitivity). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F). On 05-Feb-2021, FEELING ABNORMAL (She felt lousy for 2-3 days but got better after that.) and PYREXIA (She had a fever of 102 F for a day, after which it dropped down to 100 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever of 102°F for a day, after which it dropped down to 100°F. and 100 (High) fever of 102°F for a day, after which it dropped down to 100°F..         No treatment information was provided.   This case was linked to MOD-2022-539493 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Swelling face
Clinical narrative: left side cheek swelling; feeling nasty; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left side cheek swelling) and FEELING ABNORMAL (feeling nasty) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Pfizer primary vaccine series) and PFIZER BIONTECH COVID-19 VACCINE (Pfizer first booster). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (in spring).    On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced SWELLING FACE (left side cheek swelling) and FEELING ABNORMAL (feeling nasty). In April 2022, FEELING ABNORMAL (feeling nasty) had resolved. At the time of the report, SWELLING FACE (left side cheek swelling) outcome was unknown.            No pre-existing condition was reported. No concomitant medication was reported.     Few days after getting second Moderna booster patient felt nasty which went away and then has developed cheek swelling on his left side of the face.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021; Given past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given past the expiration date) and PRODUCT STORAGE ERROR (stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given past the expiration date) and PRODUCT STORAGE ERROR (stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vaccine was stored at within range standard freezer temperatures (Min/Max = -13.0 F to -9.0 F) between 19-Jan-2021 through 29-Mar-2021. The vaccine was moved to a within range refrigerator (35.6 F to 46.4 F) on 29-Mar-2021 at 1300 hours. booster dose (0.25 ml) was given to a patient past the expiration date of 28-Mar-2022 on 30-Mar-2022 at 1300 hours.  No treatment medications was reported.