chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Cardiac stress test normal, Cardiac valve disease, Echocardiogram abnormal, Feeling abnormal
Clinical narrative: Not felt right since 1st shot; I started with really severe heart palpitations/ the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (shingles outbreak in the eye about 2 years ago from reporting) and gluten free diet (gluten-free diet for 20 years). Concurrent medical conditions included cataract (had for over 2 years and still there which was preventing the patient from having her cataracts repaired), mitral valve prolapse (had done an echocardiogram: which showed that the patient had a valve issue which patient knew and was diagnosed with Mitral Valve Prolapse quite a few years ago in 1995), autoimmune disorder (due to celiac sprue been on a gluten-free diet for 20 years) and heart valve disorders.   On 1st March 2022, the patient received the 1st dose of Shingrix. In March 2022, immediately after receiving Shingrix, the patient experienced palpitation. On an unknown date, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved and the outcome of the palpitation was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingrix. The reporter considered the palpitation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022132678   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: The reporter was the patient. She had received Shingrix shot and she did not have the lot number but had provide her pharmacy's name and phone number, from where that information should be on file. She stated, she knew that from the very 1st shot, she had told her husband, she did not feel right since then and she still did not feel right. She stated, ever since she had the 1st dose, shortly after that she got that, she started with really severe heart palpitations. She had been to her doctor about that and she had instructed her to had the bloodwork done, which was okay, an echocardiogram, which had shown us that she had a valve issue which she knew, since she it was diagnosed as Mitral Valve Prolapse quite a few years ago from reporting and she also had a stress test done in which she had passed with no problems. However, the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix. The reporter had consented to follow-up. Additional supportive information: The time taken for onset for event - palpitations was captured as Immediately. For tolerance of 2nd dose refer case US2022132678, reported by same reporter.; Sender's Comments:  US-GSK-US2022132678:Same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Palpitations
Clinical narrative: Not felt right since 1st shot; I started with really severe heart palpitations/ the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (shingles outbreak in the eye about 2 years ago from reporting) and gluten free diet (gluten-free diet for 20 years). Concurrent medical conditions included cataract (had for over 2 years and still there which was preventing the patient from having her cataracts repaired), mitral valve prolapse (had done an echocardiogram: which showed that the patient had a valve issue which patient knew and was diagnosed with Mitral Valve Prolapse quite a few years ago in 1995), autoimmune disorder (due to celiac sprue been on a gluten-free diet for 20 years) and heart valve disorders.   On 1st March 2022, the patient received the 1st dose of Shingrix. In March 2022, immediately after receiving Shingrix, the patient experienced palpitation. On an unknown date, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved and the outcome of the palpitation was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingrix. The reporter considered the palpitation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022132678   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: The reporter was the patient. She had received Shingrix shot and she did not have the lot number but had provide her pharmacy's name and phone number, from where that information should be on file. She stated, she knew that from the very 1st shot, she had told her husband, she did not feel right since then and she still did not feel right. She stated, ever since she had the 1st dose, shortly after that she got that, she started with really severe heart palpitations. She had been to her doctor about that and she had instructed her to had the bloodwork done, which was okay, an echocardiogram, which had shown us that she had a valve issue which she knew, since she it was diagnosed as Mitral Valve Prolapse quite a few years ago from reporting and she also had a stress test done in which she had passed with no problems. However, the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix. The reporter had consented to follow-up. Additional supportive information: The time taken for onset for event - palpitations was captured as Immediately. For tolerance of 2nd dose refer case US2022132678, reported by same reporter.; Sender's Comments:  US-GSK-US2022132678:Same reporter
Sex: U
Vaccine: MENB, MNQ, PNC13, PNC20
Symptoms: Product storage error
Clinical narrative: Possibly had a temperature excursion, unknown whether or not there was patient involvement; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date unknown) and (batch number AMVA714A, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) (batch number DL2861, expiry date unknown), (batch number EK6267, expiry date unknown) and (batch number FF7357, expiry date unknown) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) (batch number FW2328, expiry date unknown) for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number EW6499, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received PREVENAR 13. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received PREVNAR 20 and TRUMENBA. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: The vaccine coordinator reported that they possibly had a temperature excursion with Menveo with batch number AMVA660A and AMVA714A for 6 minutes, temperature 2.0 Degree Celsius. The patient also received Prevenar 13 with batch number DL2861, EK6267 and FF7357 Prevenar 20 and Trumenba. The reporter stated it was unknown whether or not there was patient involvement. The reporter reported that she was looking for the stability information. Additional Supportive Information: The patient received a dose of Menveo involved in a temperature excursion, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Electric shock sensation
Clinical narrative: having electric type changes/charges in skull; This case was reported by a consumer via interactive digital media and described the occurrence of electric shock sensation in head 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 electric shock sensation in head. On an unknown date, the outcome of the electric shock sensation in head was not recovered/not resolved.   It was unknown if the reporter considered the electric shock sensation in head to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had been experiencing electric type changes/charges in his/her skull. Follow-up would not possible, as no contact, details were available. Additional supportive information: Since, it was a case received via interactive digital media and the patient/reporter does not explicitly stated of having received a shingles vaccine and the therefore, shingles vaccine" is coded as the suspect product, conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site pain, Nodule
Clinical narrative: Just below the injection site I have a lump,; injection site was sore/that is red and sore; that is red and sore; This case was reported by a consumer via interactive digital media and described the occurrence of nodule in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced nodule, pain and erythema. On an unknown date, the outcome of the nodule, pain and erythema were unknown.   It was unknown if the reporter considered the nodule, pain and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media.  The reporter stated that he/she had received first shingle vaccine on 12th September 2022. The Injection site was sore. Just below the injection site he/she had a lump, that was red and sore. The reporter had asked if it was normal or not.  Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Just below the injection site I have a lump,; injection site was sore/that is red and sore; that is red and sore; This case was reported by a consumer via interactive digital media and described the occurrence of nodule in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced nodule, pain and erythema. On an unknown date, the outcome of the nodule, pain and erythema were unknown.   It was unknown if the reporter considered the nodule, pain and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media.  The reporter stated that he/she had received first shingle vaccine on 12th September 2022. The Injection site was sore. Just below the injection site he/she had a lump, that was red and sore. The reporter had asked if it was normal or not.  Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: Bad pain up under rib cage; This case was reported by a consumer via interactive digital media and described the occurrence of rib pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pruritus (itch time was over).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rib pain. On an unknown date, the outcome of the rib pain was unknown.   It was unknown if the reporter considered the rib pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the vaccine from his/her nurse practitioner. The patient did not had itching and rash. The patient never itched in his/her life until he/she got an Intravenous in the hospital and then the patient itched like never in his/her life. Itch time was over for the patient. The patient was back to him/her that did not itch. The patient had a weird bad pain up under his/her rib cage on one side. Anyway, the patient took care before of some people who had shingles. They were in so much pain. The patient felt sad for anyone who had shingles. Additional supportive information: The follow-up would not possible, as no contact details were available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Limb discomfort
Clinical narrative: Today, the injection site from her second shingrix vaccine is sore; Vaccine arm is Heavy; first shingrix vaccine 10/25/2021 and then didn't get her second vaccine until 9/12/2022; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 954kz, expiry date 14th September 2023) for prophylaxis.   Previously experienced adverse reactions included shingles. Previously administered products included Shingrix (on 25th Oct 2021 received 1st dose from batch number ae2j4 and expiry date 30th March 2023, refer link case US2022AMR131967).   On 12th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th September 2022, the patient experienced injection site pain and heaviness in arm. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the heaviness in arm and drug dose administration interval too long were unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the heaviness in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR131967   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: The reporter is patient self-reported that she received second dose in 12th Sep 2022 (on the day of reporting) on left arm and experienced injection site pain and heaviness in arm. The reporter did not consent to follow-up.  Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule; Sender's Comments:  US-GSK-US2022AMR131967:Same patient- FU 1
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Patient  received Havrix (1440 adult); Patient received Havrix (1440 adult); Patient received Havrix (1440 adult); This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, inappropriate age at vaccine administration and expired vaccine used. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and expired vaccine used were 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: 13-SEP-2022 Reporter's Comment: The reporter who stated that a patient received an expired dose of Havrix at the time of reporting.  The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired dose of Havrix at the time of reporting, which led to overdose, inappropriate age at vaccine administration and expired vaccine used.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-SEP-2022 Reporter's Comment: The CMA (Certified Medical Assistant) reported that the patient received Bexsero vaccine which was exposed to 29.8 F. The reporter consented to follow-up via mail. Additional supportive information: The Bexsero vaccine was exposed to temperature 29.8 F, which led to incorrect storage of drug. This was one of the 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132075:Same reporter. US-GSK-US2022132077:Same reporter. US-GSK-US2022132078:Same reporter. US-GSK-US2022132079:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late 2nd Shingrix dose; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 14th September 2022, the patient received the 2nd dose of Shingrix. On 14th September 2022, unknown after receiving Shingrix, 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: 14-Sep-2022 Reporter's comment: The sales representative submitted medical information inquiry on behalf of a physician, which contains a possible late 2nd dose of Shingrix. Email was sent to safety for sales representative contact information.  Adverse event contains all reported information. Additional Supportive Information: The 2nd dose of Shingrix possible late, which led to drug dose administration interval too long.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Erythema, Injection site pain, Pruritus, Rash pustular
Clinical narrative: red "zits" on arms and abdomen; itchy red pustules on back; red pustules on back; red pustules on back; pain at injection site for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2022, the patient received the 1st dose of Shingrix .5 ml. On 5th August 2022, 4 days after receiving Shingrix, the patient experienced pruritus, pustular rash and erythema. On an unknown date, the patient experienced injection site pain and pimples. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pruritus, pustular rash and erythema were not recovered/not resolved and the outcome of the pimples was unknown.   It was unknown if the reporter considered the injection site pain, pruritus, pustular rash, erythema and pimples to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR133730   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: The patient who also was a Registered Pharmacist (RPH) who had reported that he received his 1st dose of Shingrix in left arm. He reported that he had pain at injection site for 2 days. He also reported that on 5th August 2022, he had noticed some itchy red pustules on back. He then had noticed that he had red zits on the back of both arms and some on abdomen. He went to Primary Care Physician (PCP) then to 2 dermatologist, one who did a biopsy and gave him Valacyclovir x 7 days. He stated that this was still unresolved. The reporter was referred to a Healthcare Professional (HCP). The reporter consent to follow-up via mail. Additional supportive information: The time taken to onset for the event - pruritus, pustular rash and erythema was captured as 4 days. This case was linked with US2022132695 and US2022AMR133730 for same patient.; Sender's Comments:  US-GSK-US2022AMR133730:Same patient
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Last IPV received Feb2022,  Kinrix 19sep2022; Last IPV received Feb2022,  Kinrix 19sep2022; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included IPV (last dose received on February 2022).   On 19th September 2022, the patient received the 4th dose of Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were 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: 19-SEP-2022 Reporter's Comment: The reporter reported that a child patient was received Kinrix fourth dose by mistake. The reporter stated that the patient received last IPV in February 2022. The patient was only needed fourth Tdap vaccine. The reporter stated that no adverse reaction was seen in child patient. The reporter did consent to follow up. Additional Supportive Information: The reporter reported that, they were intending to administered fourth dose of Tdap and inadvertently administered Kinrix instead of Tdap , which led to wrong vaccine administered and Inappropriate schedule of vaccine administered as Kinrix needs to be 5th dose in DTaP series.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate decreased, Rash, Rash erythematous, Rash papular, Tenderness
Clinical narrative: rash on her chest (mostly right side) that is painful to touch; little red bumps on forearms; little red bumps on forearms; low heart rate, several days; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th September 2022, less than a day after receiving Shingrix, the patient experienced heart rate low. On 16th September 2022, the patient experienced red rash and papular rash. On 19th September 2022, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was not recovered/not resolved and the outcome of the red rash and papular rash were recovering/resolving and the outcome of the heart rate low was recovered/resolved.   It was unknown if the reporter considered the painful rash, red rash, papular rash and heart rate low to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Sep-2022 Reporter's comment: The reporter stated that her wife got her first Shingrix vaccine.  The patient received Shingrix vaccine in left arm. She stated on the day of the vaccine, they noticed that she developed a low heart rate that lasted for several days.  The caller reported that the day following the patient's vaccine, the patient developed little red bumps on her forearms that were gradually getting better. The caller also reported that the patient had developed a rash on her chest mostly right side that was painful to touch.  The reporter did not consent to follow-up.  There was no Healthcare professional for follow up. The permission for consent to follow-up was denied. Additional supportive information: Less than a day after vaccination the patient had heart rate low. 1 day after vaccination the patient had red rash. 4 days after vaccination the patient had rash.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at the injection site; Golf ball size swelling at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   On 2nd August 2022, the patient received Shingrix. In August 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Sep-2022 Reporter's comment: The registered pharmacist called and stated that the patient received Shingrix and experienced redness at the injection site.  The registered pharmacist stated that about two weeks later the patient experienced golf ball size swelling at the injection site that was unresolved.  Adverse events was filed.  Outside phone number for GSK Medical Information given for future reference and warm transfer provided.  The consent to follow up was granted. Additional Supportive Information: Less than 2 months after vaccination the patient had injection site erythema.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago prior to the reporting).   On an unknown date, the patient did not receive 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: 21-SEP-2022 Reporter's Comment: The reporter wanted to know what should he do. The reporter did consent to follow up via email. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN LEGS; BLOOD CLOTS IN LUNGS; HEART PROBLEMS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, and expiry were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. 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 heart problems, blood clots in lungs, and blood clots in legs. It was reported that, " The vaccine is dangerous. After receiving it I developed serious heart problem and blood clots in legs and lungs which Cardiologist attributes to the vaccine. My previously healthy heart was functioning 20 percent. Kids were called to come to say their good bye. Doctor says it was a miracle I recovered. It frightens me that they are giving it to children." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart problems, blood clots in lungs, and blood clots in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220935326- covid-19 vaccine ad26.cov2.s-blood clots in legs. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220935326- covid-19 vaccine ad26.cov2.s-blood clots in lungs. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Arthropathy, Death, Ill-defined disorder
Clinical narrative: DEATH; JOINT ISSUES; APPETITE ISSUES; OTHER HEALTH PROBLEMS; This spontaneous report received from a consumer via social media through a company representative concerned an elderly female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and at the age of 88, the patient had been in a hospital once before the vaccination. On an unspecified date, the patient was previously vaccinated with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 01 total (dose 1) administered for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (manufacturer unspecified) (Dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (manufacturer unspecified) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total (dose 2) administered for covid-19 prophylaxis. 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 joint issues, appetite issues, and other health problems (Dose number in series 2). On an unspecified date, the patient died from unknown cause of death due to the second Covid vaccine (Dose number in series 2). It was unspecified whether an autopsy was performed or not. It was reported as "After a few long weeks of joint issues, appetite issues, and other health problems I lost my healthy mom to the second Covid vaccine. At 88, she had only been in a hospital once before the vaccination." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint issues, appetite issues and other health problems was not reported. This report was serious (Death).; Sender's Comments: V0: 20220940060-covid-19 vaccine ad26.cov2.s-death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via social media through a company representative concerned a middle aged patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient was healthy. 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, 1 total (dose 1) administered for covid-19 prophylaxis. 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 died from blood clot. It was unspecified if an autopsy was performed. It was reported as, "I personally know someone who was a healthy person middle aged had there life cut short cause of a blood clot caused by this vaccine I'm sorry everyone isn't you". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot was fatal. This report was serious (Death).; Sender's Comments: V0: 20220943772-covid-19 vaccine ad26.cov2.s-Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Off label use
Clinical narrative: FLU; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via social media  through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received two doses of covid-19 vaccine (unspecified manufacturer), (Dose number in series 1), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered start therapy date were not reported for covid-19 prophylaxis. The patient had no issues following two doses of vaccination (Dose number in series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 2).  The patient had no issues following booster vaccination. It was reported "I had no issues until the 2nd booster (Dose number in series 2). The patient received second booster with covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The product was associated with Off label use (Off label dosing frequency) (Dose number in series 3). 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 flu (Dose number in series 3) and it was reported as "I had no issues until the 2nd booster. Got the new one and flu. Not much" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu and off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220941610.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: Big hive; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (Big hive) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included LEVOTHYROXINE and AMLODIPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INJECTION SITE URTICARIA (Big hive). At the time of the report, INJECTION SITE URTICARIA (Big hive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included was diphenhydramine.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-117740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Upon internal review on 20-Sep-2022, non-significant correction was performed to update case level seriousness. On 07-Apr-2021: No new information received. On 14-Apr-2021: No new information received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Intentional product use issue
Clinical narrative: Fell down in her drive way (14 days After first dose)/ I was in an accident; Second dose scheduled  for 154 days after the first dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENT (Fell down in her drive way (14 days After first dose)/ I was in an accident) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ACCIDENT (Fell down in her drive way (14 days After first dose)/ I was in an accident) (seriousness criteria hospitalization and medically significant). In July 2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose scheduled  for 154 days after the first dose). At the time of the report, ACCIDENT (Fell down in her drive way (14 days After first dose)/ I was in an accident) and INTENTIONAL PRODUCT USE ISSUE (Second dose scheduled  for 154 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. No Treatment information was provided. Patient missed her second Moderna COVID-19 Vaccine dose. She made an appointment for 20-Jul-2021 to receive the second dose at a local Pharmacy.  Very limited information regarding  these events have been provided at this time. No further information  is expected at this time.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant follow up On 16-Jul-2021: Upon internal review on 16-Sep-2022 non-significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding  these events have been provided at this time. No further information  is expected at this time.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (her sister died after the 2nd Moderna vaccine/ cardiac arrest) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included COPD and Emphysema. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (her sister died after the 2nd Moderna vaccine/ cardiac arrest) (seriousness criteria death and medically significant). The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that patient died after the 2nd Moderna vaccine, she went into cardiac arrest and died several hours later. Patient was transferred to the closest hospital where she was pronounced. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This fatal spontaneous case concerns a female of unknown age, with no medical history reported, who received the second dose of her COVID19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The reporter mentioned the patient went into cardiac arrest and died several hours later. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This fatal spontaneous case concerns a female of unknown age, with no medical history reported, who received the second dose of her COVID  19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The reporter mentioned the patient went into cardiac arrest and died several hours later. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report. Reported Cause(s) of Death: Cardiac arrest.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspepsia, Fatigue, Nausea
Clinical narrative: Heartburn; Dizzy; Nauseated; Tiredness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), DIZZINESS (Dizzy), NAUSEA (Nauseated), FATIGUE (Tiredness) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Small cell lymphocytic lymphoma. Concurrent medical conditions included Lymphocytic lymphoma. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In April 2022, the patient experienced DYSPEPSIA (Heartburn), DIZZINESS (Dizzy), NAUSEA (Nauseated), FATIGUE (Tiredness) and FATIGUE (Fatigue). In April 2022, DIZZINESS (Dizzy), NAUSEA (Nauseated) and FATIGUE (Tiredness) had resolved. At the time of the report, DYSPEPSIA (Heartburn) and FATIGUE (Fatigue) had not resolved. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ear pain, Fatigue, Headache, Insomnia
Clinical narrative: Sleeplessness; Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears; Headache; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), EAR PAIN (Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears), HEADACHE (Headache) and FATIGUE (FATIGUE) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa. No Medical History information was reported. On 23-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. In April 2021, the patient experienced INSOMNIA (Sleeplessness), EAR PAIN (Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears), HEADACHE (Headache) and FATIGUE (FATIGUE). At the time of the report, INSOMNIA (Sleeplessness), EAR PAIN (Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears), HEADACHE (Headache) and FATIGUE (FATIGUE) had not resolved. No concomitant and treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.