chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever, nausea and vomiting, chills, and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back
This spontaneous case reported by a consumer, describes the occurrence of menstrual disorder  (patient had a full menstrual cycle in December 2021) in a female patient, of an unknown age,  who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. December 2021, patient experienced menstrual disorder (patient had a full menstrual cycle in December 2021). At the time of the report, menstrual disorder (patient had a full menstrual cycle in December 2021) outcome: unknown. The patient had a full primary series of the Moderna COVID-19 vaccine in the spring of 2021. Patient said she has not had a cycle in 1 and ½ years. No concomitant medication or treatment information reported.
HOSPITALIZATION AND DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID-19 VACCINE SERIES
Patient fell asleep on the way home from her vaccinations. She woke up within an hour or so. Around 3:00pm she spiked a fever of 104.4 so I gave her Tylenol. 4-6 hours later I gave her Motrin and a luke warm bath. Her fever remained high for 3 consecutive days and eventually breaking by day 4. I continued alternating the motrin/tylenol during this time as medical professionals in my family suggested. During that time, she began banging her head like she was in pain, screaming a very loud pitch sound I had never heard before and just wasn't "herself" The fever broke, but her behaviors continued. Within 4-6 weeks she lost all words, eye contact, and socialization. Her behaviors remained the same and I then took her into her Pediatrician. Her doctor referred us to a Ped Neurologist where they then began tests. She began to have chronic ear infection and tubes were placed in July 2018 by Dr at the Medical Clinic.
Headache, chills, nausea and the worst side effect was swollen gums, open sores/ abrasions inside mouth on gums lasting for several days.
Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha  Day 4..... headache, cough diarreha
Pt s/p ROTARIX 4/15/17. On evening of 4/26/17, et had abdominal discomfort. On 4/27/17 pt had vomiting and bloody stool. Seen in office and referred to ER. (+) intussusception (ileocecal) on U/S. (+) reduced w/o complication.
Rash all over body. Hives and redness painful and extremely itching. Cannnot sleep from itchiness.  It has been 14 days now with no improvement.
pt recv vax 7AUG89 & 10AUG96 pt devel rubeola confirmed by lab test;
lt leg, groin to knee, got very sore w/in a couple of hr of the inj;knee was very swollen the next day;was sore & has erythema over the knee & leg;had t100.2 oral noc of 24MAY;knee was tender w/moderate effusion when exam 25MAY
C/O feeling Anxious and having a fast heart rate  Vital signs were monitored and were WNL  She wanted to return home, was seen by MD @ site and was sent home
Rash Vesicular Information has been received from a health professional concerning a 5 and a half year old white patient who on 19-FEB-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 07-DEC-2005 the patient experienced rash for seven days that was worsening. The patient was seen in the office on 16-DEC-2005 with 30 isolated vesicles with excoriation. Subsequently, the patient recovered. Additional information has been requested.
The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was 1st punctured @ 9:30 am on 18Nov2021 then was left at room temperature until this dose was administered @ 8:45 am on 19Nov2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received their first dose from Johnson and Johnson and the date of administration was unknown.  This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 039F21A. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 11 hours and 15 minutes past its first punctured time. (first puncture date and time: 18 November 2021 at 9:30 A.M; mRNA-1273 vaccine administration date and time: 19 November 2021 at 8:45 A.M, mRNA-1273 vials should be discarded 12 hours after the first punctured time). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 039F21A. The event expired product administered occurred right after the booster dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 11 hours and 15 minutes past its first punctured time. (first puncture date and time: 18 November 2021 at 9:30 A.M; mRNA-1273 vaccine administration date and time: 19 November 2021 at 8:45 A.M, mRNA-1273 vials should be discarded 12 hours after the first punctured time). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
swollen induration in site of injection; swollen induration in site of injection; This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Menveo. In September 2020, less than a week after receiving Menveo, the patient experienced extensive swelling of vaccinated limb and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site induration were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site induration to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not reported. The patient presented a 10 x 9 inch swollen induration in site of injection after the first dose. Batch number or expiration date and patient's initials was not known.  The reporter consented to follow up.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 02-OCT-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location or administration were unspecified). The vaccine underwent a total temperature excursion, of 912 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Staff/patient was given shot of 0.50 ml Janssen on the L arm site detoid area at approx 15:04 pm after signing the consent, educational h/o & education given, verbalized understanding, questions answered; observed for 15 minutes per protocol, no c/o any s/e; tolerated procedure well as documented at 15:19 post observation. Staff went for PCR testing per CRC protocol for unvaccinated EE.  After PCR test at approx 15:42, staff c/o slight dizziness & no other complaints. Assessed & V/S taken & were WNL (documented). Staff then requested rapid test for c/o slight dizziness; staff stated he has no Covid sx; explained to staff that POC test is done if there's Covid sx (enumerated) & will be sent home after test;
Weakness, inability to work, my parents had to drive to my work site to pick me up and drive me home. I was unable to drive or carry luggage. I experienced diarrhea, difficulty breathing, high fever, weakness,  and tiredness. These symptoms lasted approximately 5 days.
pt recv vax & devel chills, a feeling of hot & cold, explosive diarrhea, aching eyeballs & hurt muscles; No further details were provided;
High Blood Pressure (170/78) I do not have hypertension. Irregular vaginal bleeding. Starting bleeding mid cycle for a day. This has never happened to me. I have a normal menstrual cycle.
This spontaneous report as received from a nurse practitioner refers to a 21 years old patient who on 19-AUG-2008, was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). The nurse stated that the patient might have received improperly stored GARDASIL. The nurse did not have the nature of the excursion because another facility sent the letter informing her of the incident. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a consumer via field employee refers to a 17 year old male patient. On an unknown date, the patient was vaccinated with GARDASIL 1 injection, intramuscular for prevention of HPV (human papillomavirus). On an unknown date, the patient fainted and fell to the side after being administered GARDASIL. No treatment was given for the adverse event. The outcome of fainted and fell to the side after being administered GARDASIL was unknown. Additional information is not expected because no reporter details were provided.
Patient was previously administered the Pfizer Monovalent vaccine number 1 in the series on 04/14/2023, 3 weeks prior, and was given the Pfizer Bivalent as 2nd dose in series prior to the 8 week recommended time frame. No adverse signs or symptoms have occurred. Pfizer was notified and recommendation is revaccination of Pfizer Bivalent 1 dose in 8 weeks from administration date of 05/06/2023
12/18 vaccination 12/19 Nausea started in afternoon. Fever off and on; comes and goes. Nausea, vomiting has consistently been present till present date.  PCP,video chat; blood work and possible nausea meds is scheduled for 2/8/2021. *it is not all the time, it comes and goes. Some days better then others.  I had to leave work on 4 occasions.
Immediate dizziness, hot flashes, felt like rapid onset of flu. Fibromyalgia symptoms went into intense unprecedented flare. Fibromyalgia symptoms at intense level persisted for many months afterwards and continue to date.
88-year-old male brought to the emergency room for generalized weakness and confusion.  History is the patient had a positive COVID test 4 days ago.  I believe he was started on doxycycline.  The patient also has a history of COPD and has been on prednisone intermittently.  The patient has been fully vaccinated and has had a booster.  The patient was hypoxic in the emergency room tonight.  He is confused.  He has a white count of 18000 with a left shift.  Procalcitonin is elevated at 1.71.  BUN and creatinine are elevated at 66.5 and 2.2 which is a new finding.  His baseline creatinine is around 1.1.  Initially he presented in atrial fibrillation with rapid ventricular response but his rate became controlled prior to any intervention.  The patient has a history of having a Watchman device although when asked he states that he is on an anticoagulant.  I cannot find any record on the prescription list of any anticoagulant that he is currently taking.  He was admitted to this facility in November of 2021 and at time of discharge was not on any anticoagulation.  The patient has been borderline hypotensive in the emergency room.  He has received a couple of fluid boluses which have helped his blood pressure.  Chest x-ray does show interstitial prominence and a left pleural effusion which appears small but also appears new.  The patient has a history of diastolic heart failure.  His last echo was November 4, 2021 with an ejection fraction of 50-55% but did demonstrate diastolic dysfunction.  I have been asked to admit the patient for his presumed sepsis and COVID pneumonia.  INPATIENT AT THIS TIME.
Patient was inadvertently given a booster dose (0.25 ml) instead of a 0.5 full first dose.
This case was reported by a pharmacist and described the occurrence of increased sleeping time in a 30-month-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 September 2013 the subject received 1st dose of FLUARIX (.5 ml, unknown details) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for FLUARIX. On 24 September 2013, less than one day after vaccination with FLUARIX, the subject experienced increased sleeping time. Per the reporter, the subject "slept for 4 hours after the injection during naptime." The subject "usually only sleeps 1 hour during naptime." At the time of reporting the outcome of the event was unspecified. No additional details were provided by the pharmacist.
Information has been received from a physician concerning an 16 year old female who on 12-JUL-1994 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 19-MAY-1997, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 09-DEC-2009, the patient experienced mumps (diagnosed date reported as 30-DEC-2009). The patient was afebrile and had left side parotitis. The patient was reported as being exposed to mumps. On 30-DEC-2009, the IgM was <1.1 the IgG was 6.92 and serum amylase was 282. The outcome of the mumps was not reported. Follow up information has been received concerning the 16 year old male patient who on 12-JUL-1994 and on 19-MAY-1997 was vaccinated with the first and second doses of MMR II (route and lot # unknown), respectively. On 19-NOV-2009 the patient experienced mumps (he was diagnosed on 20-NOV-2009). The patient was afebrile and had L parotitis. On 20-NOV-2009, an IgM, and IgG and a serum amylase test were performed and results were 0.34, 3.81, and 176 respectively. At the time of the report the patient's outcome was unknown. No further information is available.
This case was reported by a healthcare professional, via GSK representative, and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included TWINRIX; GlaxoSmithKline given on an unspecified date. On an unspecified date the subject received 2nd dose of TWINRIX (details unknown) 7 days after the 1st dose as per the accelerated schedule. At an unspecified time after vaccination with TWINRIX, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. The vaccination course with TWINRIX was discontinued. The healthcare professional considered the event was probably related to vaccination with TWINRIX. It was reported that the subject was referred to a neurologist who confirmed that the Bell's palsy was due to administration of the accelerated schedule of TWINRIX.
On 11/27/00 the pt received Prevnar and on 12/21/00 she was diagnosed with Type 1 Diabetes. There is no family hx of diabetes.
Client called 6/25/13 at 1630 to report onset of pain and achiness to arm where injection received, area red at injection site this started on 6/22/13 redness improved still is present although better, 6/24/13 reported a lump on (Lt) side collarbone arm remains achy along with muscles under arm. C/O pain from lump up neck.
pt recvd vax 10NOV94 & same evening, informed MD that arm hurt (which recvd vax);arm was red & swollen from elbow to shoulder;bruising @ inj site;treated w/ice & DPH 11NOV;pt reported severe chills;recovered;
Muscle or body aches,  New loss of taste or smell,  Fatigue or tiredness, breakthrough COVID-19
Injection site became very swollen and red.  Continued to swell more of next couple days and became bruised.  Swelling, buising, and redness covered whole side of thigh size larger than grapefruit.
Pt developed fever, chills, swelling at the injection and purpura like rash on lower legs.
PEG allergy; just now recovering from horrible symptoms of eruption from Pfizer vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "medication allergies: cabergoline, Midrol, Levaquin adverse tendon pain, Cipro, Penicillin " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMERS ALLERGY (non-serious), outcome "unknown", described as "PEG allergy"; IMMUNISATION REACTION (non-serious), outcome "recovering", described as "just now recovering from horrible symptoms of eruption from Pfizer vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the patient was oddly told to remain compliant by neurologist after Covid vaccinations as it turned out that patient have a PEG allergy and patient was just now recovering from horrible symptoms of eruption from Pfizer vaccination approximately 3 weeks after 1st jab. Other description: Aimovig 140mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to clinic on 26-Jul-2017, in no acute distress, 3 days after receiving Anthrax #6 and Rabies #1 on 23-Jul-2017, with chief complaint of Itching, burning, and swelling to the right deltoid muscle. Physical examination Skin- Deltoid with mild edema and erythema with tightness noted to the muscle. No LAD noted. Patient was given DIPHENHYDRAMINE 25MG, LORATADINE 10MG, and ACETAMINOPHEN 325M. Patient reported relief of symptoms within 4 hours of presenting to clinic with use of medication. Patient released with no work restrictions and to follow up as needed if symptoms do not decrease or worsen. Patient encounter documented in AHLTA.
Swelling arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     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 PERIPHERAL SWELLING (Swelling arm) and RASH (Rash). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-398870, MOD-2021-398894 (Patient Link).
Information has been received from a physician concerning a 21 month old male who on 08/23/2003 was vaccinated with MMR vaccine live. On 06/10/2004 a titer was taken and the pt was found to be negative for mumps. No other symptoms noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
patients received the vaccine that was stored for longer than 2 weeks in the freezer; patients received the vaccine that was stored for longer than 2 weeks in the freezer; This is a spontaneous report from contactable other health care professional reported similar events for 12 patients. This report is the 3rd of 12 reports. A 14-year-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0177, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 02Jun2021 (at the age of 14-year-old) as single dose for COVID-19 immunisation at Doctor's Office/Urgent Care. The patient medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine that was stored for longer than 2 weeks in the freezer on an unspecified date. It was reported, HCP explained that patients received the vaccine that was stored for longer than 2 weeks in the freezer. Their vaccine should have been removed from the freezer on 01Jun2021. However, it stayed longer in the freezer. The patient received the vaccine on 02Jun2021 (which was one day over the allowed 2 weeks in the freezer. The outcome for all events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021664910 similar report from same reporter
Initial report was received 05 February 2013 from the investigator for a trial. A 20-year-old male subject (medical history and concomitant medications not reported), had received ACAM2000 on 16 May 2012 and a previous dose of ANTHRAX vaccine on 02 May 2012 (routes and sites of administration not reported). On 22 May 2012 at 04:00 hours, six days after receiving ACAM2000, the subject developed chest pain described as twisting in the middle of his chest (mid-sternum) rated 5/10 on pain scale which resolved that same day at 12:00 hours. He had no other associated cardiac symptoms. No further episodes occurred and no treatment was sought. On 28 May 2012, troponin level was drawn (results <0.10 ng/mL) and rapid test was negative at that visit. He also had an ECG performed with normal findings and was released back to duty. Medical notes indicated possible follow-up for a stress test upon return to base. On 16 June 2012, medical notes indicated the subject was assessed properly with appropriate follow-up and no further action was required. The event was reported as recovered/resolved on 28 May 2012. According to the investigator, the event of chest pain was possibly related to the study vaccine. Documents held by sender: None.