chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Black diarrhea; Lethargic - didn't feel like doing anything; Not feeling good  like when you are coming down with something; A spontaneous report was received from a Healthcare Professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events black diarrhea/melaena, lethargic - didnt feel like doing anything/lethargy, not feeling good like when you are coming down with something/malaise.  The patient's medical history included constipation. Concomitant medications reported were Fluoxetine, Rosuvastatin, Zonisamide, Pregabalin, Alendronic acid, Prednisone, Multivitamin, Aspirin, Calcium for drug use for unknown indication.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events black diarrhea, lethargic - didnt feel like doing anything and not feeling good like when you are coming down with something.  The event of black diarrhea was considered to be serious with criteria of important medical event.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events black diarrhea, lethargic - didnt feel like doing anything and not feeling good like when you are coming down with something was resolved on 31 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (Lethargy, and malaise) a causal relationship cannot be excluded. Very limited information regarding the events (Melaena) has been provided at this time. Further information has been requested.
Pt had hives/rash after first SHINGRIX vaccine 8/16/18. Administered about 12pm and pt reported rash started in the evening, started on arms and abdomen, moved to groin and elbows "shingles-like" rash that waxes and wanes (gets better and then worse on its own). Pt went to urgent care and the providers determined it was likely an allergic reaction to the vaccine.
Headache starting at 9:00 AM Syncope event after getting out of bed around (blurred vision, fall, ringing in ears) 1:30 PM  Fever 101 noted right after syncope event  Fatigue, Weakness throughout day   Used damp cloth to cool myself and took Tylenol as directed. Symptoms resolved the next day.
FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine.; FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine.; severe HA's; achy bones/muscles; achy bones/muscles; weak; sleeping for sev days; night sweats; This is a spontaneous report from a contactable other hcp (patient). A 72-year-old (non-pregnant) female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EVV 0217) via an unspecified route of administration, administered in arm left on 08Sep2021 12:00 at dose 3 (booster), single for covid-19 immunisation. Medical history included Hashimoto's, Mast Cell act, High BP, often have adverse reactions to meds (known allergies: Often have adverse reactions to meds). Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); lisinopril (LISINOPRIL) both taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient previously received first and second dose of BNT162B2 for COVID-19 immunization. On 09Sep2021 12:00 the patient experienced had severe HA's, achy bones/muscles, weak, sleeping for sev days, night sweats. Adverse event: FYI: I had a very strong reaction to the Booster (3rd shot) Vaccine. Starting following day I had severe HA's, achy bones/muscles, weak, sleeping for sev days, night sweats. I had no reaction to the 1st two shots, so surprised with reaction. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the adverse events. Outcome of the events was resolving.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.
Groggy, listless, aimless stare, woke screaming and unconsolable (very high pitched); cried intermittently for no reason (again unconsolable).
PATIENT MISTAKENLY RECEIVED PFIZER BIONTECH VACCINE AS 2ND DOSE INSTEAD OF MODERNA VACCINE.
2nd  booster.  Site of injection has swollen hard lump that is red and  noticeably warm to the touch. Slightly itchy. Started small this morning (12 hours after shot) and continuing to grow at 24 hours after. This was my first Moderna shot. First 3  (initial 2 and first booster) were Pfizer and I did not have this reaction.
history of random urticarial rash for last 3 months, abnormal lab work, elevated IgA, IgE, ANA titer positive on 3/11/2010 at immunologist office visit
Information has been received from a consumer concerning her currently 26 year old daughter with penicillin allergy who on an unspecified date was vaccinated with a dose of GARDASIL (site, dose and lot# not reported). The patient's mother reported that her daughter had "lost about 1/4 of her hair amount, mostly at the crown", after receiving the second dose of GARDASIL. At the time of the report, the patient was recovering. The patient did not seek medical attention. The relationship between GARDASIL and the adverse event was unknown. No further information is available.
Pt was supposed to receive a flu vaccine, but instead received an additional dose of pfizer covid 19 vaccine. Pt had previously received a booster for pfizer on 11/20/21. No other adverse effects have been reported at the time of this writing.
After injection, patient jolted and eyes fluttered. He seemed to be having a seizure like reaction. He then slumped to side and head hit side of wall since we had chair with side rails positioned against wall. He lost conscious for maybe 30 seconds and then eyes opened. I asked if he was OK and the first thing he asked for was water. He said he felt light headed and dizzy. I had my intern who was working grab him water from the deli and had him sit and rest. He started sweating and asked for paper towels. I grabbed him a couple of towels so he can wipe his face. I continued to check on him while doing my work. He seemed fine after that. After 30 minutes, I checked his blood pressure. It read 100/63.  I continued to monitor him and he left after that. He did have friend with him the entire time who helped him.
This was an out-of-the-blue psychotic episode which I have never had before. Likewise, I do not use any substances, nor have I had experiences of sexual assault or abuse. The doctors at the hospital were not able to give me a diagnosed mental health condition.  Tuesday, September 27:     Fluzone quadrivalent vaccine from  Health Center (flu shot clinic) Saturday, October 1:     rollerbladed in the evening, stayed up until 2:00am working on homework Sunday, Oct 2:    delusion thoughts, inability to concentrate October 3, Monday:    religious delusions, loss of appetite, insomnia, amnesia, abnormal sexual comments, flashes of light in vision Tuesday, October 4:     aggressive comments to roommates, locked myself in a bathroom for 3 hours with little recollection later, stared at mirrors and out windows (no recollection of doing this), suicidal remarks, inability to think rationally, religious delusions. Taken to the Clinic at 4:00pm then immediately transferred to Hospital. Attempted to leave hospital, assaulted a police officer, delusions and hallucinations of being sexually assaulted by the police officers, sedated and put on a stretcher and sent to the ER.  Wednesday, October 5:    Transferred to another wing of hospital, continued amnesia for large chunks of the day, inability to form coherent sentences, delusions, hallucinations, difficulty concentrating.  Prescribed with 2mg of risperidone at night to help with psychotic symptoms Saturday, October 8:    requested 1mg of risperidone instead, able to think and function rationally again Wednesday, October 12:   discharged from hospital with safety plan
At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021; The injection site also itches Started; Last 5 days she has an ongoing rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Last 5 days she has an ongoing rash), VACCINATION SITE WARMTH (At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021) and VACCINATION SITE PRURITUS (The injection site also itches Started) in an 80-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300042722) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (Last 5 days she has an ongoing rash). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site also itches Started). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021). At the time of the report, RASH (Last 5 days she has an ongoing rash), VACCINATION SITE WARMTH (At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021) and VACCINATION SITE PRURITUS (The injection site also itches Started) outcome was unknown.        The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown.
Pain in arm and flu-like symptoms. Symptoms came on 20 hours after the vaccine was administered and then subsided a bit then returned stronger than before, which is the current state. Have been getting a flu shot every year for quite a few years and have never had an adverse reaction before.
RN inadvertently gave the patient a ped/adolescent dose of Hep A to the 22 year old patient instead of the adult Hep A dose.
This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 09-SEP-2014 the patient was vaccinated with an improperly stored dose of PROQUAD (strength unknown, 0.5 ml, subcutaneous) exposed to -8 degree for two hours. This is one of several reports received from the same reporter (linked to 1409USA007877). Additional information has been requested.
Fever, headache, rapid heart rate, lower leg cramps,  Acid indigestion, very dry mouth These adverse events started around midnight (which was around 12 hours after the injection) and continued for at least 4+ hours during the night. The fever and headache was intense. I took 2 ibuprofen in the morning . Also the site of the injection was extremely painful. I also had similar events that lasted much longer after my 1st Moderna injection on 1/29/2021 and they also started about 12 hours after the injection.
The patient experienced no symptoms; On 27-JUL-2020 a patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drugs reactions or allergies were not provided.  On 27-JUL-2020, the patient was vaccinated with with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered subcutaneously (strength, dose, vaccination scheme frequency, and anatomical site of vaccination were not reported; lot number S031497 has been verified to be a valid, expiration date reported and validated as 07-OCT-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number S038697 has been verified to be a valid, expiration date reported and validated as 10-AUG-2022).  The administered dose of the vaccine experienced a temperature excursion of 28.4 degrees Fahrenheit for 6 hours and 38 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Patient presented to emergency department in afib RVR with heart rate in 180's. Patient has no known history of afib, and stated that the heart rate of 180 started several days prior to arriving to emergency department. Patient was given IV push of 15mg cardizem, heart rate came down to 130. Patient then placed on cardizem drip at 10 mg/hr. Afib still present, but heart rate controlled in 120's. Patient underwent transesophageal echocardiography with cardioversion in order to convert patient back to normal sinus rhythm. Patient also stated that she slept for an extra 4 hrs/day for several days following vaccination and developed a scaly rash on injection site. Patient currently admitted in ICU under close monitoring.
Itching, redness at injection site approximately 1 week post-vaccination.  Triangular, red, raised area, approximately 4x4cm.
Heart racing, jittery inside, arm ached, dizzy, lightheaded - lasted 5 hours. Treatment with Ibu. Then got muscle aches, eyes burning, fatigue, sick headache. Next day was the same, plus nausea and exhaustion. Night at too sick to sleep or get up. Thursday - diarrhea - watery, with same symptons as before. Unable to eat - just fluids.  Friday - very fatigue, eyes still hurting, same on Saturday and Sunday and Monday - still tired but muscles not achy and no diarrhea.
per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 2/10 and 1/13. Patient is admitted for mild congestive heart failure secondary to cardiomyopathy
This is my second shot of the Moderna vaccine.     I also had a reaction after the 1st shot which I will also summarize here:  1st shot - 4/3/21 - sore arm for 2-3 days, fatigue for a week.  At day 7 my arm became swollen and I had a red rash for another 2-3 days.  2nd shot - 5/4/21 - On 5/5/21 I experienced a sore arm along with headache, dizziness,  extreme fatigue and flu-like symptoms (chills, fever) and general brain fog.   I was in bed all day.   On 5/6/21 - I am still experiencing moderate dizziness.
Soreness in her back, legs and feet; Cold symptoms; Bones were hurting; Soreness in her back, legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Soreness in her back, legs and feet), NASOPHARYNGITIS (Cold symptoms), BONE PAIN (Bones were hurting) and PAIN IN EXTREMITY (Soreness in her back, legs and feet) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BACK PAIN (Soreness in her back, legs and feet), NASOPHARYNGITIS (Cold symptoms), BONE PAIN (Bones were hurting) and PAIN IN EXTREMITY (Soreness in her back, legs and feet). At the time of the report, BACK PAIN (Soreness in her back, legs and feet), NASOPHARYNGITIS (Cold symptoms), BONE PAIN (Bones were hurting) and PAIN IN EXTREMITY (Soreness in her back, legs and feet) outcome was unknown.            No concomitants medication were provided.  No treatment medication were provided.  No lab data has been provided by the reporter.   Reporter did not allow further contact
Three inch by two inch red rash with pimples followed by bruising and itchy for 5 days and persisting.  Arm weak and sore.
administered Menactra to a patient subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 18 years old female patient who had administered menactra to a patient subcutaneously instead of intramuscularly with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 14-Apr-2022, the patient received 0.5ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (frequency, strength was unknown, lot U6952AA and expiry date: 09-Jun-2022) via subcutaneous route in unknown administration site for prophylactic vaccination.  It was reported that Patient last menstrual period was on 25-Mar-2022. On 14-Apr-2022, (Latency: same day) Nurse administered menactra to a patient subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration) and they just want to know what to do moving forward. Nurse just wants to know if the dose needs to be repeated.   Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
For 40 hours after injection: joint pain, skin pain, fever, pain in lungs for regular/deep breathes (had to shallow breathe), vomiting twice, nausea, nearly passed out 3 times (I recognized the oncoming feeling and laid down immediately).
pt recvd vax; w/in 12 hrs post-vaccination, exp a swollen lt arm, & a lump at the inject site (lt arm);exp redness radiating down her lt arm & into back;lt arm pain & back pain;vax given on lt arm;
No additional AE/PQC; Inbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX. Temperature: -12.48 C; This spontaneous report was received from a consumer and refers to a 5-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 17-JUL-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, subcutaneously in the left arm, lot number X006983  with expiration date 07-MAR-2025 for prophylaxis. The vaccine was stored at -12.48 degrees Celsius for 1 hour and 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Rash developed 24 hrs after shots. Pt very irritable. Scratching skin. BENADRYL was rx to relief itching.
Injection site pain; Tiredness; Felt fuzzy; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021, the patient experienced injection site pain, tiredness and felt fuzzy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site pain, tiredness and felt fuzzy were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt states pain began on date of event; pain at site of injection that has caused tenderness in her right upper arm into her armpit. States there is slight shoulder joint pain rated on a scale of 4/10. Date of injection 9/14, report submitted on 9/18.
Shortly after TD vaccination, I developed arthritis (on toe & frozen fingers upon awakening every AM) and tingling, "Pins & needles", burning sensation in hands & feet diagnosed as mild case of peripheral neuropathy (idiopathic) no known cause. I have no idea if these health issues are related to TD vaccination but I wanted to report it.
Usual Right arm tenderness at injection site, tired, achy, and headache.  But at 3pm, he developed hives most pronounced on arms and legs, but present on torso and back.   He was given Benadrly 25mg and 1000mg Tylenol and went to bed at 10pm.  When he awoke the next am at 6:30, all was resolved.  He did NOT have any difficulty breathing, shortness of breath, trouble swallowing, lip or tongue edema.
Young man came to clinic for vaccine.  Name and DOB verified for identification.   screening reviewed and client reported to be of appropriate age for vaccine.  Vaccine given.   After clinic, age of client realized and mother was called to verify DOB.  Mother verified that DOB in is accurate, and that client is 17 years old.  She stated that she completed  screening for client, verifying that he was of appropriate age for Moderna vaccination.
Information has been received from a physician concerning a 59 year old female with no pertinent medical history who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently, the pt experienced general malaise, fever of 101, body ache, joint pain and swelling at injection site. No labs or diagnostic studies were performed. Unspecified medical attention was sought, but no prescription drug was required. No product quality complaint was involved. Additional information has been requested.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/21/2021 and 02/18/2021. They became symptomatic for COVID-19 on  10/28/2021 and tested positive for COVID-19 on 10/29/2021 at a clinic. They were admitted to hospital on 11/01/2021. They were found to have pneumonia and their health continued to decline. Per the individual's wishes, they were put on comfort care only and had a DNR order in place. The individual died on 11/13/2021.
Site: Pain at Injection Site-Mild, Additional Details: Patient reported blood shot eyes on the same side as the arm they got the shot in.
pt had severe allergic rxn large local (8inches x 3 inches) & systemic rxn that lasted 3 days; fever, body aches, fatigue;