chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had very light bleeding for about a week and a half/ I have NEVER had periods for this long or this frequent; Slightly sore arm at the injection site; This is a spontaneous report from a contactable female consumer (patient). A 30-year-old non pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP6955) via an unspecified route of administration in right arm on 26Mar2021 12:45 pm (age at vaccination: 30 years) as dose 2, single for COVID-19 immunisation. Medical history included PCOS from an unknown date and unknown if ongoing. Concomitant medications were reported as none. Historical vaccine includes first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6200) via an unspecified route of administration in right arm on 05Mar2021 12:45 pm (age at vaccination: 30 years) as dose 1, single for COVID-19 immunisation and the patient had had my period for almost 5 weeks straight, heavier bleeding than usual, Much stronger cramps. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. On an unspecified date on Mar2021, after second dose of vaccination, the patient had very light bleeding for about a week and a half. The patient had started another period and this one seems to be similar to the one she had after the first dose. She stated that she should note that she have NEVER had periods for this long or this frequent. The patient PCOS so her body is used to not having them for months. Even after going a year without one while pregnant and nursing, it still only lasted 5 days. The patient had no other symptoms other than a slightly sore arm at the injection site. Treatment was not received for the adverse event. The outcome of the events were not resolved.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1707USA011793: US-009507513-1707USA011201: US-009507513-1707USA011790: US-009507513-1707USA011791.
Suspected vaccination failure; Seldom get flu; feel sick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and feeling unwell. On an unknown date, the outcome of the vaccination failure and influenza were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza and feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The patient received flu, I have had a flu shot in the past just made me feel sick for 3 to 4 days.  This case was considered as suspected vaccination failure as time to onset, and laboratory confirmation test were unknown at the time of reporting.
Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.   No Medical History information was reported.    On 10-Feb-2022 at 10:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial was opened on 09 Feb 2022 at 10:00 am. She further reported that the vial was not discarded and sat out in room temperature for a little over 24 hours.  No treatment information was provided by reporter.
heart rate increased; Abdominal cramp; Dizziness; decrease blood pressure; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased), ABDOMINAL PAIN (Abdominal cramp), DIZZINESS (Dizziness), BLOOD PRESSURE DECREASED (decrease blood pressure) and TACHYCARDIA (tachycardia) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (shellfish and scallops).    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate increased), ABDOMINAL PAIN (Abdominal cramp), DIZZINESS (Dizziness), BLOOD PRESSURE DECREASED (decrease blood pressure) and TACHYCARDIA (tachycardia). At the time of the report, HEART RATE INCREASED (heart rate increased), ABDOMINAL PAIN (Abdominal cramp), DIZZINESS (Dizziness), BLOOD PRESSURE DECREASED (decrease blood pressure) and TACHYCARDIA (tachycardia) outcome was unknown.            No relevant concomitant medications were reported. Patient was given diphenhydramine 50 mg in the emergency room for treatment. She reported having no symptoms with first dose.
12AM awoke with R arm in pain, nose congestion and pressure in sinus, occasional urge to vomit, nausea
This spontaneous report as received from a pharmacist refers to 10 adults of unknown age. Since July 2014 the adults were inadvertently vaccinated with 10 doses of pediatric RECOMBIVAX HB, 5mcg/0.5ml, 0.5ml,  once, route unspecified. Pharmacist reported that she made this error in part due to the lack "PEDIATRIC" wording on labeling. No adverse effects were reported. Additional information has been requested.
Approximately 2 days post vaccination individual experienced a sudden onset of headache, felt hot, started sweating then reportedly lost consciousness.  During episode bystanders state patients eyes rolled back in her head, she vomited and she urinated on herself.  Episode lasted a few seconds and was not followed by a post ictal period. Patient was taken to ER and subsequently admitted for further evaluation.
pt recvd Hep B vax approx 130PM; c/o itchiness & rash; c/o face swelling & throat tight;
After patient received the Men B(Trumenba) she started feeling bad. She turned pale & began to vomit & felt like she was going to pass out. She vomited twice. We were able to get the patient cold compress & some juice. It took her a few minutes to recover. Mom and sister were with her. Did call mom today(8/3/22 around 4:50pm. She stated that patient was feeling better this evening.
My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes; my bones hurt; felt like I'd been run over by a truck; I felt tired, like the flu; My muscles were sore; I felt tired; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and MYALGIA (My muscles were sore) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: DPT. Past adverse reactions to the above products included Near death experience with DPT. Concurrent medical conditions included COPD.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu), MYALGIA (My muscles were sore) and FATIGUE (I felt tired). In August 2021, the patient experienced FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes). On 18-Jul-2021, FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and FATIGUE (I felt tired) had resolved. At the time of the report, FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt) and MYALGIA (My muscles were sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided  Reported that patient had COPD, stamina and endurance, all that gone at the time of report. When patient got the inoculation, DPT, when he was a kid, patient almost died. When patient went to get the 1st dose patient told them about that. They put him off for a few months. On 16Jul2021 patient got the 1st dose of the Moderna Covid-19 vaccine. A couple of hours later, patient felt like he would been run over by a truck. Patient felt tired, like the flu, patient felt like that for 3 days. Muscles were sore, patients bones hurt and soul was hurt. August 2021 a month later, patient felt changes. Patients shins felt like he jumped off a 10 story building.   No treatment information provided   This case was linked to MOD-2022-672550 (Patient Link).
pt vax hepta B.  immed. after vax pt ex chest pain. pt recovered.  pt vax 2nd and 3rd vax w/ no noted problems.
04Apr90 pt 2nd vax;  23May90 devel swelling & pain in left cervical area of neck.  Serum amylase 383.  Tx w/ APAP.
I received shot on 1/15 and had the normal sore arm and redness. Then the following week nothing. Saturday 1/23 woke up with headache took Tylenol and ate egg sandwich and arm that received shot started to feel a little numb as if blood was not circulating right then area where I received the shot got really hot and big red circle and started to hurt again as if I just got vaccine again. Lasted until Monday 1/25 and then everything was fine. You can still see a nice size circle at injection site.
patient contracted pneumonia even after receiving pneumococcal vaccine; patient contracted pneumonia even after receiving pneumococcal vaccine; This is a spontaneous report from a contactable other HCP.  A 57-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) at single dose on an unspecified date for immunisation.  The patient medical history was and concomitant medications were not reported.  The patient contracted pneumonia even after receiving pneumococcal vaccine on an unspecified date.  The patient was hospitalized for pneumonia for 5 days in Nov2019. outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Information has been received from a physician concerning an 18 weeks male patient who on an unspecified date was vaccinated with the first dose of ROTATEQ. No adverse effect was reported. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician's office manager who indicated that the patient was an 18 weeks female patient (previously reported as male) who on 11-FEB-2010 was vaccinated with the first dose of ROTATEQ. Concomitant vaccinations included the second dose of PENTACEL and the second dose of pneumococcal conj vaccine (unspecified). The office manager stated that they did not provide ROTATEQ to the patient. The patient's first visit to the reporting physician's office was for her six month well check on 09-APR-2010. The office manager confirmed that according to the patient's mom, there were no adverse events. It was also reported that ROTATEQ was administered at a public health clinic/hospital. Additional information is not expected.
Patient presented to the ED and was subsequently hospitalized on the same day of vaccination, 3/19/2021.
Extreme lethargic and soreness starting out first couple of hours. Then began tingling and prickling sensations both arms below elbow to hands upper side and both legs below knee to top of feet.  A few hours later, I had no sensation in fingers on right hand and fingers were ?locking?. Fever of 103 late Saturday into midday Sunday but this am down to 101. Low grade headache but not extreme. Urinated 7 times in middle of night and had nothing to eat minimal to drink and I never have to get up at night, I had to fall out of bed and crawl to toilet as EXTREMELY NO ENERGY. I live alone and no family close so I couldn?t even get to ER.
Patient started having a very sore arm on 11/19/2021 and then by 11/20/2021 it became swollen and one big red lump on it.  There was no puss and no warmth.  She didn't take anything for it.  Now on 11/22/2021 (Monday) it is better.  There is still a small spot that is not swollen or red, but is VERY tender still.
Several areas other various locations of diamond shape rash. C/o itching 0 SOB or other signs of distress.
Chills; So sick that could not get out of bed; High fever over 102 F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (So sick that could not get out of bed), PYREXIA (High fever over 102 F) and CHILLS (Chills) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (They got the COVID and quarantine for 4 weeks.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (So sick that could not get out of bed) and PYREXIA (High fever over 102 F). On an unknown date, the patient experienced CHILLS (Chills). On 18-Jan-2021, MALAISE (So sick that could not get out of bed) outcome was unknown. At the time of the report, PYREXIA (High fever over 102 F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 102 (High) fever over 102 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient has severe spine problem and takes medications for that. Patient took ibuprofen for treatment of adverse events.
Choked on vaccine during administration; limp; Wrong technique in drug usage process; This serious case was reported by a nurse via call center representative and described the occurrence of choking in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   On 02-OCT-2023, the patient received Rotarix lyophilized formulation (oral). On 02-OCT-2023, immediately after receiving Rotarix lyophilized formulation, the patient experienced choking (Verbatim: Choked on vaccine during administration) (serious criteria GSK medically significant), limping (Verbatim: limp) and wrong technique in drug usage process (Verbatim: Wrong technique in drug usage process). On 02-OCT-2023, the outcome of the choking and limping were resolved.The outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the choking and limping to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the choking and limping to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 03-OCT-2023 and 04-OCT-2023 The reporter reported that baby choked during administration of Rotarix.  Prior to administration baby was not crying and during the last bit of Rotarix started choking, went completely limp and the baby recovered after 1-2 minutes, mom fed baby and CNA was able to give rest of vaccine, which led to wrong technique in drug usage process. The reporter grabbed baby and ran to the provider to determine if baby was holding breath and the baby was not.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2023136408, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023136408:Same reporter
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with incorrectly stored VARIVAX (Merck) (lot number J006695, expiry date 30-MAY-2015) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality issue reported. This case is linked to case number 1504USA022809 via same reporter link. Additional information has been requested.
Guillain-Barre syndrome; tingling extended over his entire body; lightheaded; malaise; flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 7th January 2019, the patient received Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced light headedness. On 14th January 2019, the patient experienced tingling. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling were unknown.   It was unknown if the reporter considered the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling to be related to Shingrix.  additional details: The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine on 07 January 2019. January 7, he had the SHINGRIX vaccine. January 8, he had malaise and a flu syndrome. January 11, he felt lightheaded and faint with tingling beginning in his toes, extending up his leg to knees. January 14, the tingling extended over his entire body. His body was red, He felt lethargic. He had no actual muscle weakness but noted decreased functional ability at the gym. The diagnosis of Guillain-Barre was made. He received IVIG in the hospital. The tingling decreased and has receded such that it is present from the knee down through his shins into his feet. He notes the occasional tingling in his hands since the onset of symptoms. His walking and balance are 80% improved. His balance and coordination are improved, and he is not dropping objects.
Patient received 1st SHINGRIX dose on 4/13/18. He said his arm was sore but otherwise minimal reaction. After receiving the 2nd dose of SHINGRIX on 7/29/18 the patient said his arm was very sore around the injection site and painful. He said he also had flu-like symptoms with aches and feverish feeling for about 3 days following the injection. He said he knew it wasn't the flu and was still able to go to work.
administered an expired of Moderna monovalent vaccine to a patient today; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today).    No concomitant medications were reported. No treatment medications were reported.