chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT COMPLAINED OF LOW BLOOD SUGAR AND ANXIETY. PATIENT DRANK OWN ORANGE JUICE HE HAD BROUGHT WITH HIM.  PATIENT STATED FEELING BACK TO BASELINE
About 20 minutes after shot, I felt pressure in my chest. I felt like I could not catch my breath. I went to the pharmacist, she ask if I had I felt like something was in my throat. I told her no. She said then I am not having a anaphylactic reaction. Then she if I wanted her to call emergency services. I went and sat back down. These symptoms continued on for about a week. When I walked or do any activities it would get worse. I was also very fatigue and tired that whole week as well.
Information regarding poliovirus vaccine (manufacturer unknown) was received from an attorney regarding a female patient who experienced malignant brain tumor. The patient received vaccine. Medical History: Relevant medical history was not provided. Product Details: Indication for poliovirus vaccine was immunization. Product was administered "during the 1960's." dose regiment was not provided. Concomitant therapy: Concomitant medications were not reported. Event Details: The attorney alleges that the polio vaccine received by the decedent contained a harmful prohibited animal virus known as Simian Virus 40 (SV 40). The Simian Virus 40 contained within the polio vaccine product was the cause of the malignant brain tumor (brain neoplasm malignant) that caused the death of the decendent. The decendent died on 03-Dec-2001. No additional information was available at the time of this report.
Patient developed a welt and rash around the vaccine site approximately 5-6 days after  the vaccine. As with her twin sister, I waited a few days to see if it would resolve before scheduling a visit with her doctor. The day of the visit (03/09), pt had 102.2 fever and had bumps that had developed around the injection site. By 03/11/2018 pt had developed a few more bumps around her chest and back. She developed a milder version of chicken pox than her sister did and by Monday was doing fine. For reference, her sister's E-Report Number is 135180.
FULL FLU LIKE SYMPTOMS STARTING THE DAY AFTER VACCINATION; EXTREME FATIGUE, PERSISTENT BODY ACHES, CHILLS, FEVER, HOT FLASHES, HEADACHE. THOSE LASTED UNTIL THE NEXT MORNING. THE 2 DAYS FOLLOWING THAT, I HAD GREEN BOWEL MOVEMENTS AND ABDONIMAL CRAMPING.  THERE IS A WELT AT MY INJECTION SITE AND HAS BEEN ITCHY. I DID NOT EXPERINCE THAT WITH MY 1ST 2 DOSES. NOW 5 DAYS AFTER THE INJECTION, I AM ONCE AGAIN FEELING EXTREME FATIGUE AND BODY ACHES.  I HAVE NOT FELT LIKE "MYSELF" FOR 5 DAYS NOW
States was in severe pain the evening of receiving the vaccination and for the whole week following it. Had discomfort for a second week also. States had a raised area at site of injection. That lasted about 1 week. She took MOTRIN for the pain.
Severe chills; shaking like a leaf; This is a spontaneous report from a contactable Consumer. This Consumer reported for 83-years-old female patient (mother) that: A 83-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, NDC/UPC number: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included allergy, dementia with lewy Dementia, difficulty in walking and weak-all were from an unknown date and unknown if ongoing. It was reported that she just have difficulty in walking and she is very weak and I have to put her on a wheel chair. She has got Lewy Dementia (not appropriately paraphrased and clarified). Diagnosis date of Dementia: Probably a year ago. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for cognitive reasons, start and stop date were not reported (Reporter stated, Very small amount for her cognitive reasons) and clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for allergy, start and stop date were not reported (Reporter stated, it was a just regular over the counter). On an unspecified date, the patient experienced severe chills and shaking like a leaf. Reporter stated, was just calling to let you all know that my mother had her second shot and she was having a reaction like she had chills, she was shaking like a leaf. She is 83 years old. She was sleeping right now. So was there anything else that we have to worry about. Anything serious. Reporter further stated, I guess I will take her to the ER if it is serious. Reporter was informed about role of Pfizer Drug Safety department and was provided with the number of Pfizer Medical Information Department. Reporter stated, she had severe chills today and I woke her up and she was shaking and now she is asleep. We gave her a Tylenol 600 and she is in sleep right now. Prescribing Healthcare professional details: Reporter stated, No, it was a regular facility. The patient received Tylenol 600mg as treatment for the adverse events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SORE ARM--HEADACHE--BODY ACHES --SCRATCHY THROAT --FATIGUE
EXCRUCIATING PAIN THROUGH MY WHOLE BODY. COULD NOT BE TOUCHED WITH OUT SCREAMING IN PAIN. COULD NOT LIFT MY ARMS, STAND UP OR WALK  FOR TWO MONTHS. MY CHILDREN PICKED ME UP AND CARRIED ME IN AND OUT OF BED AND TOOK ME TO BATHROOM WAS IN AND OUT OF EMERGENCY ROOM AND URGENT CARE BETWEEN 80 AND 90 TIMES IN 6 MONTHS.
Varicella Information has been received from a physician concerning patient (between elementary school age and high school age) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In approximately November 2005, "between November and December 2005" the patient experienced breakthrough chicken pox. There were 20 lesions or less. Unspecified medical attention was sought. Subsequently, the patient was fine and recovered form chicken pox. No product quality complaint was involved. Additional information has been requested.
Diarrhea starting 12/25/20 at 11:00 am (5-6 episodes in a 24 hour period)
10 patients received expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Elevated temperature of 99.5, headache, tired, severe nausea beginning following (Sat) morning, severe vomiting Saturday evening. Nausea persisted Sun and part of Mon.  Able to eat normal food Mon night but had nausea after eating. Able to eat normally Tues.
the 8 month old patient recived 2 doses of Menactra  2 month and 6 days apart, no AE; the patient received first dose of Menactra when she was 8 month and 18 days old, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00437336) and transmitted to Sanofi on 20-Jan-2021.  This case involved an 8 month and 18 days old female patient who was vaccinated with the first dose (one dosage form) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on an unknown date of Sep-2019 (product administered to patient of inappropriate age) and the second dose (one dosage form) of same vaccine received at the age of 10 months and 14 days (total duration 2 months and 6 days) (Inappropriate schedule of product administration) on an unknown date of Nov-2019 (batch number and other dosing details were not reported) for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   This was an actual medication error due to drug dose administration interval too short and Inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event reported to the patient.  The reporter wanted to know if this vaccination was enough.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
Nothing happened right away but a few weeks after the 1st vaccine, he ran a temp and then March 20 he was very sick, 103 temp, weak, unable to stand on his own, confused, delirious. Rushed him to Urgent Care, they sent him home and the next day I took him to ER. He was admitted. MRIs, CT scan, Blood Cultures, 2 Covid tests.  Nothing definitive as to why he was so ill other then a viral infection.   We are not assuming or indicating it is vaccine related but we think it's worth noting.  Nothing in his routine had changed other then receiving the 1st vaccine.   No one at the hospital indicated it was related.
Vaccinated 9-11-07. On 9-14-07 patient reported local reaction at injection site. On 10-2-07, patient reported shingles rash on buttock. "Small patch". Self treated with valacyclovir orally and penciclovir cream topically. Resolved in about four days without sequelae.
fever, 100.8, achy, very tired.  Took advil felt better within 24 hours.
Report A0375498A describes the occurrence of learning disabilities in a male child of unspecified age who received hepatitis B vaccine recombinant. This report was received as part of litigation preceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On unspecified dates, the child received his first, second and third injections of Engerix B (lot ENG1992A2, ENGENG220A2; ENG220A2 is not a valid lot number). He also received hepatitis b vaccine recombinant (Recombivax-HB), DTaP/DTP, DTaP (Acel-Immune), and Haemophilus influenzae type b conjugate (Hib-Titer). The child's attorney alleged that "The highly toxic emissions of certain pwer production facilities in the environmental zone of the Plaintiff's residence contributed to the Plaintiff's total dose of poisonous mercury. Because of Plaintiff's heightened vulnerability to heavy metals poisoning and his compromised condition related to the mercury poisoning discussed above, he was and unable to process heavy metals and suffers neurological compromise as a result of the heavy metals contributed by the fossil-fuel burning utilities. His impaired condition is compounded by these exposures and his injury is made worse by them. The Plaintiff was poisoned by the cumulative doses of mercury in the environment and, as a result, the Plaintiff now suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning." The attorney further alleged that "After being injected with Thimerosal and inhaling mercury-contained emissions, he had the following symptoms: severe learning disabilities, impairments in social related ness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. His problems are caused by Thimerosal and the mercury and/or other heavy metal contained therein." The "severe" learning disabilities, impairments in social relatedness, language difficulties, communication difficulties, and mercury poisoning in this report are considered medically serious.
Extreme tiredness and lethargy and weakness in both arms. Unable to open things using hands and wrists.
Pain, redness, swelling, tenderness in the left arm that has spread to involve a large area of the arm. Symptoms started 2 days after vaccine administration.
This spontaneous report was received from a registered nurse refers to a 4 month old patient of unknown gender. On 12-NOV-2014 the patient was vaccinated with ROTATEQ dose 1, oral (strength and lot # were not reported). No adverse effects had been observed or reported by the time of this report. Additional information has been requested.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # L0101142 with expiration date of 24-SEP-2016, lot # L026728 with expiration date of 15-JAN-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
BACK ACHE; LETHARGY; MINOR CHILLS; This spontaneous report received from a patient via a company representative concerned a 25 year old male. 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 not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced back ache. On 10-APR-2021, the subject experienced lethargy. On 10-APR-2021, the subject experienced minor chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back ache, lethargy, and minor chills. This report was non-serious.
got the second dose on 23/Apr/2021 (day 108); tested positive for COVID-19 11 days after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 11 days after receiving the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 23/Apr/2021 (day 108)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19 11 days after receiving the first dose). On 23-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 23/Apr/2021 (day 108)). The patient was treated with BAMLANIVIMAB at a dose of 1 dosage form. On 23-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 23/Apr/2021 (day 108)) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19 11 days after receiving the first dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
A report has been received from a Physician concerning multiple patients with unknown age and gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. On the 2nd, rd, and 4th of January, the patients received FLUMIST, that expired at the end of December 2012. The outcome of the event of FLUMIST THAT EXPIRED IN END OF DECEMBER AND WE GAVE IT TO PATIENTS is unknown. The report was considered to be non-serious by the reporter.
1/25/11 Mother called to report onset 2 days ago of redness & swelling (L) thigh in area of vaccine administration 4 days prior (1-19-11). Child rec'd 3 vaccine injections in (L) thigh that day as noted below. Mother states increase in swelling & redness today - has golf ball size lump & itching - states looks like bee sting. No fever, no limp just tender to touch. Advised to have physician exam. Seen by Dr on 1-25-11. Rx ORAPRED & BENADRYL. Stated prob reaction to MMRV. Was able to note injection site of DTAP above - no reaction. As of 1/31/11 reaction resolved.
By the night the day of vaccination the following started: chills, nausea, red rash by vax site, itchy, fell ill. Next morning went to walk-in clinic, did not get any recommendations. By the next day, did not take any medicine.
7/29/21 G2P2 F, presents via ems after spontaneous delivery of baby F at home
Patient was administered the third dose since immunocompromised on 10/13/21 at 11AM from a vail that was thawed and held at room temperature from 1:15 PM the previous day and was held at room temperature since. (beyond 12 hours expiration window once punctured)
infection at the injection site; long raised red itchy hard spot at injection site and was raised and hot; redness at injection site; injection site itch; A spontaneous report was received from a Consumer concerning a  78Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08-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 Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 14-JAN-2021, The patient experienced the events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site.  Laboratory details were not provided.  Treatment details in narrative include Her neighbor got the vaccine at the same location and they said it was an infection and gave antibiotics. She went to her doctor and he said he would give her antibiotics in case. She is wondering if this is a normal reaction.  Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site was Not Recovered/Not Resolved.  The reporter assessed the events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site related to the study drug was unknown.
Patient came in for her 2nd Moderna vaccine shot. She had had a similar reaction after her first shot which was also reported to VAERS. She said her first shot reaction lasted until that evening but she was fine the next day and willing to get the 2nd shot. We administered the shot and asked her to wait for 30 mins for observation, because of her history. After 30 mins, we checked on her and she said her arm felt a little numb. We called our local EMS service and they came to check on her. They allowed her to go home after checking on her. I called and spoke to the patients mom/caregiver a couple of hours later. She said the patient was doing better and felt a little worn out. She also mentioned that the patient had a headache, for which I recommended some tylenol.
Patient experienced vaccine site reaction resulting in very bad pain, skin itching and skin pain. She also developed a moderate rash and used VALTREX to treat it. Resolved quickly.
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came.  Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
1st shot 3/13/2021 my left arm still hurts 4 months later. Not a constant pain but for example if i stretch or try to sleep on my left side or if i flex my muscle. Even though it hurt i did have my seconfd shot on 4/15/2021 Please advise am getting very concerened
Weakness loss of appetite 1wk after  trouble breathing body  hicups  heart attack death (almost 2 wks after)
Case number PHEH2014US025382 is an initial spontaneous report from a pharmacist received on 13 Dec 2014. This report refers to a female patient of an unknown age. On an unknown date in 2013, she was vaccinated with FLUVIRIN (batch number: not reported), intramuscularly. It was reported that the patient received only partial dose of FLUVIRIN as a means of tolerance of flu vaccine. No adverse event reported following this medication error.
This spontaneous report has been received from a Registered Nurse referring to a patient of unknown gender and age. No concurrent or medical history were reported. On 18-MAY-2015 the patient was vaccinated with VARIVAX (dose, route and frequency unknown, Lot number reported as J013278 - expiration date 30-Oct-2015 (the lot number was not valid for VARIVAX). The nurse reported that the VARIVAX was improperly stored. No adverse event was reported. No further information was provided. This is one of several cases received from the same source (#MARRS 1506USA012333, 1504USA005104, 150USA020362). Additional information has been requested.