chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wanted to jump out a window; In "agony"; Couldn't sleep for 36 hours; Intense chest pain (felt like an Myocardial infarction); Had to crawl back to bed on hands and knees; Chest pain resolved in 10 minutes; Dizzy; Bilateral redness on cheeks; Pain "unbearable"; Head started pounding; Chills (not too bad); Felt like knives were going into her head through both eyes; Sore injected arm; Felt as if she could unzip her head, and let the pressure out she would feel better; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)) and GAIT DISTURBANCE (Had to crawl back to bed on hands and knees) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included multivitamin, Emer-GN-cee   This case was linked to US-MODERNATX, INC.-MOD-2021-078099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078099:
Patient called and stated pain in shoulder starting shortly after the vaccine was administered, once returned home on 09/26. Unable to significantly move arm without pain/discomfort. Pain not relieved by OTC pain mediation. Pain persisted into next day when following up via phone call at 3:30pm 09/27.
Pruritus; Erythema; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pruritus) and ERYTHEMA (Erythema) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Pruritus) and ERYTHEMA (Erythema). At the time of the report, PRURITUS (Pruritus) and ERYTHEMA (Erythema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 16-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L000450 and expiration date 09-MAR-2016) 0.65 ml once, subcutaneous. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
After the first vaccine I had pericarditis for about 2 hours. The second vaccine I had pericarditis for 1 day. I didn?t get any treatment as I have re occurring pericarditis and knew what it was.
Today I began experiencing nausea, body aches, diarrhea, and chills.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This Physician reported a similar event for 2 patients. This is the second of two reports. A patient of unknown age, gender and race/ethnicity received on an unknown date first single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. The patient had an extensive rash after receiving meningococcal group b rlp2086. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017408555 same reporter, event and drug/different patient.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number S008153 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.
Swollen, inflamed right arm. Severe pain, muscle cramps in hands and feet, enlarged gland under right arm, very painful. Increased temp 100-102, nausea, fatigue, heavy and pressured feeling in chest, pain and soreness in lower back area. First symptoms, approximately 18 hours, post vax.
About 5 minutes after the shot I felt a quick moving tingling sensation near site of shot, which was the left arm, then the sensation radiated up and down the same arm and then up to my neck. It then radiated to my left side near my back and stayed there. My heart beat was a little fast and my head began to feel overtly heavy but not dizzy. After an hour symptoms subsided and I was left with a very bad headache.
After receiving the vaccine I had pain at the site of injection. When I caught COVID-19 I had congestion, cough, a low grade fever between 99 to 101 degrees, body aches, and fatigue. I called an urgent care and they gave me a prescription for Paxlovid. I took the 5 day course of it, and then 3 days after not taking the Paxlovid anymore the cough and congestion came back. I called urgent care again. I have been taking Sudafed, Afrin nasal spray, Tylenol, Robitussin DM during the day, and Robitussin with codeine at night.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first dose of 0.5 ml VAQTA 25/0.5 U/ml (lot number not reported) on 02-APR-2012 and the second dose on 27-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Pt. states that after receiving the 1st dose of Moderna 12/29/2021, started experiencing symptoms 01/06/2022 of weakness, feeling faint, and feverish. No noted Primary visit/communications. Pt. still experiencing symptoms.
After the shot was administered, patient was asked to sit for 15 minutes for monitoring. Within 5 min after administration, patient said she was feeling hot and sweaty. We provided patient with a cold bottle of water and ask her to take small sips. Also gave her ice pack to apply to get her to cool down. After few more minutes, patient stated that she was itchy and having burning feeling thru her body. We asked the mother to see if she would like us to call 911 but the child told the mother she will let us know if that was necessary. We asked her to sit longer at this point because of how she was feeling. Few more minutes passed by and patient was starting to feel a little better but the burning didn't go away. She tried to take a walk with her mom in the store to see if she can shake it off, but returned after about 10 min stating that when she walks, the burning feeling is getting to be excessive in her feet. So I asked her to sit for few more min and said they are ok to leave when they feel comfortable but if condition worsens, they should go to ER.  I told mom to keep very close eye on her and that she should lay down when she gets home.  Next morning, I followed up with a phone call. Spoke to patient and she said everything seems fine now and that it started going away after few hours of administration.
Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patient 1 month beyond Use by date.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on11-Jan-2023 and Dose was administered on 09-Mar-2023).    No concomitant medications were reported. Vial size was reported as 2.5 mL. Vial was initially stored in the refrigerator on 11-Jan-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8735), on 05May2021 as dose 2, single (Lot number: ER8735) and on 23Nov2021 as dose 3 (booster), single (Lot number: EW0183) for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraine" (unspecified if ongoing); "IBS (constipation)" (unspecified if ongoing), notes: IBS (constipation); "mild sleep apnea" (unspecified if ongoing), notes: mild sleep apnea. Concomitant medication(s) included: TOPIRAMATE, start date: 01Jul2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Throat and vocal cord spasms, leading to uncontrollable coughing and gagging and trouble breathing in and out. Excessive sweating and hot flashes. Treatment was nebulized lidocane and epinepherine, along with a number of other nebulized medications, steroids, and anti nausea medication. Active symptoms lasted about 30 hours. For the following 5-10 weeks I had episodes of coughing up watery, pink, foamy liquid, and intense gagging without throwing up. I still have allergic symptoms that began after the vaccine reaction: fatigue, crampy stomach pain with diarrhea, skin rash, hives and swelling, joint pain, hair loss, low grade fever.
Became ill 11/9/10 fever, h/a, cough on 11/16/10 large left positive deep vein thrombosis and bilateral pulmonary emboli dx.
after recv vax 5/97pt on 3/98 devel breakthrough chickenpox, had a scattered papular rash w/less than 25 lesions
Fever 102 Vomiting (more than 4 times) Strong headache Fainted/black out/ passed out/ involuntary loss of consciousness and muscle control (woke up on the floor, remember trying to get from bathroom where I was vomiting to my bedroom where someone could see me. I was afraid and felt like something bad was happening to me and I knew I needed someone to find me. Lost faculties quickly. Stumbled and held on to the wall to get me from one area to the other, approx 6 ft., and I don't remember entering the room. I woke up feeling faint and was aware of the loud thud from me hitting/falling to the floor. I wasn't aware of the actual blacking out. ) Arm pain for a week  Phantom arm pain where I still feel the numb/tingly feeling where my shot was as of June 25.   The pharmacist's application of my second dose hurt me excruciatingly. The first shot I barely felt and was painless. Arm pain came a 1/2 day later. First experience/dose was arm pain, mild fever 100, headache, and fatigue.
A miscarriage was determined on 1/18/2021. There is no history of miscarriages.
A consumer report has been received. The report concerns a 21 year old, female consumer, who had been receiving FLUMIST quadrivalent (intranasal), half dose. FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced pharmacist forgot to take the clip off and she only received 1/2 the dose in one nostril and sore throat. The outcome of the event of pharmacist forgot to take the clip off and she only received 1/2 the dose in one nostril and sore throat is unknown. The report was considered to be non-serious. Corrected report: 31-Oct-2013: Have you reported this AE previously field ticked.
had a rash on her legs, by her lower heals and ankles/ also had a rash on her arm; This is a spontaneous report from a contactable other health care professional (Nurse) patient. A 51-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Second dose administered on 14Jun2021 at 13:00 in left arm. Medical history included covid-19 in Mar2021, pneumonia, anaphylactic shock four times. Chronic allergies. Nothing was working for her. She survived on Vicks. Concomitant medication(s) included vitamin b complex (VITAMIN B), cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID), hydrocodone bitartrate, paracetamol (NORCO) taken for neck pain She can take it four times daily as needed for pain. She takes it a minimum of one tablet every 12 hours. The patient previously took sulfa 12 for hypersensitivity and experienced hypersensitivity. On 24May2021 (within eight hours post vaccination) patient experienced had a rash on her legs, by her lower heals and ankles/ also had a rash on her arm. She did not have a fever or anything like that. There Is a Product Complaint that she takes for her neck, the pain does not go away. The outcome of event rash was recovered (within 24 hours) on an unspecified date in 2021.   Follow-up attempts are needed. Further information is requested.
On May 23-26 I woke up with sore throat and cough and I knew I had COVID because I had just attended a conference over the weekend.  May 28th, I felt like I had a fever although I never took my temperature. I drove back home on Saturday night, and I took aspirin at 8am and again at 10.  The medication did help then Sunday May 29 the symptoms were intermitted cough runny nose temp was 100.2 at 16:00 hour took 2 aspirin then. I felt hypotensive when I got up to walk to another room and then that resolved. The temperature was then normal 2200. The next day which was May 30 I had a productive cough, sore throat, normal temperature, and I want to Urgent care 1400 that day. I took an antihistamine 1730 for the runny nose. The Doctor gave me a prescription for Paxloviod that I didn?t fill that day. The next day which was the 31 I took my first dose at 1100 and I had no fever and intermittent cough, and loose stool. Took the Paxlovid as prescribed the next few days. My symptoms stayed the same all through June. On June 2 I still had a positive at home test then on June 3rd still positive and I didn?t sleep well at all the night before. June 4th Saturday I didn?t sleep well the night before and I had a slight headache due to Paxlovid and I took another test and for the very first time I was negative at 10:15 am. The last dose of the medication that night. I monitored myself for the next few days ?I had a slight headaches on June 5th  and then it resolved. I had soft stool on June 6 and the only other symptoms were sneezing.  June 7  Tested negative and I still had soft stool  June 8  Soft stool and some vivid dreams  June 9 I slept well normal bowl movement  June 10 I didn?t sleep well  Cough several times but it resolved 1100 Normal stool Negative Test  June 11 Slight cough over night and when I woke up but that resolved A slight positive test -which I called a relapse to Paxlovid   During this entire time I have been isolated  June 12  Soft stool in the morning  At home test 1000 negative I felt a-symptomatic  June 13  Negative at home test  June 14 Negative test and normal bowl movement  Residual  cough in the morning  June 15  negative test  I slept well  June 16 No symptoms June 17 No symptoms
Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering.  No follow-up attempts are Possible. No further information can be obtained.
Information was received on 11-MAY-2017 from a male consumer who is the patient. The patient did not report any medical history, concomitant medications or current conditions. On 11-APR-2017, the patient received a dose of ZOSTAVAX (lot, expiration dose and site were not reported). After receiving the vaccine, (date not specified) he had "joint, muscle and everything else pain". The outcome was not reported. It is unknown if he received any treatment. No other information was reported. Additional information is not expected. No contact information.
This spontaneous report was received from a pharmacy technician and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. Since 04-MAR-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035692 with an expiration date 07-NOV-2017 for prophylaxis (doses, routes of administration and anatomical location were not reported). There was no adverse experience reported.  Administered doses of ZOSTAVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 40 minutes. There was no previous temperature excursion, A digital data logger was was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015675: