chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered greater than 12 hours post puncture; Dose administered greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered greater than 12 hours post puncture) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient took the second booster dose. The vial was initially stored in the refrigerator on 22 Mar 2022. The vial was first punctured on 04 Apr 2022 at 9 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was less than 10 total minutes while drawing but otherwise the vial was in the fridge. The vial exposed to room temperature for greater than 24 hours.   No treatment medications were reported.   This case was linked to MOD-2022-533442 (Patient Link).
I?ve seemed to develop what has been identified as ?Covid arm.? Developed 9 days after first Moderna dose. Large, red circle about 2-3inches in diameter on left arm at injection site. Mildly tender, itchy, raised. Overall I feel fine.
next day extreme fatigue, fever lethargy.  Got better but never got energy back and had some body aches and trouble sleeping.  On Wed. March 25th an EXTREME headache began and I could find no relief with High doses of Tylenol or Ibuprophin or a mixture of both. It was my whole head. Stayed on the couch all day Saturday and Sunday  27th and 28th unable to move because of the pain and extreme fatigue.  Monday the 29th made myself go to work but was not able to function or get much relief.  On Tuesday the 30th went to see physician who said he thought it was Occipital Neuralgia and gave me prednisone and said use hot compresses. Told him I thought it was more due to other symptoms like hallucinations (shadows I would see) Mind not clear and made me worry about driving. Asked if the shot could be a possibility. He just said he couldn't rule it out.  The doctor also mentioned I felt very hot but never took my temperature. I Took the prednisone. Headache did start to clear on Wed the 31st in the evening but my neck seized up where I could no longer turn it to the left and was very painful. Also felt like my lymphnodes were swollen.  I called on call doctor and they prescribed a muscle relaxer.  I did not start to get better until Sunday April 11th. Experience a couple occular migranes as well during this,  Still experiencing some fatigue and almost to a fainting point in the mornings
15 x 7 cm area of warmth and redness on left shoulder at site of recent flu shot. Close observation, patient instructed to call if sxs worsen, or do not resolve in few days.
Approximately two weeks follow the first vaccination, my sense of taste  and smell to a lesser degree, has changed. It has worsened following the second vaccination. It primarily affects certain food types (starches like potato based foods, corn, certain grains, nuts, sweetened sodas). Certain smells have been affected as well, the most noticeable is related to celery which has become overpowering. Also, the smells of the aforementioned foods are also different.
Within about 90 minutes of vaccination, patient developed tremors, a very high fever (104.5), and somnolence; he was hard to arouse and wouldn't stay awake for more than a few minutes. About 6 hours later, he also had projectile vomiting and full-body jerks. The fever lasted for more than 24 hours, and the tremors and jerks persisted for about 18 hours. He was also quite swollen at all three injection sites within 30 minutes of vaccination; I know this is a common reaction.
stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX; CRESTOR. Patient has no known allergies. Vaccination history included: Bnt162b2 (approximately 4 weeks after taking the Pfizer COVID vaccine in 2022), administration date: 2022, for COVID 19 immunization, reaction(s): "stroke". Patient have no covid prior vaccination and post vaccination. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 27Oct2023 at 07:00, outcome "not recovered", described as "stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Echocardiogram: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of cerebrovascular accident and included treatment with blood thinners and meds.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353195 same patient/AE, different vaccine dose number;
28nov89 pt vax hepta B. late dec pt ex flu-like illness & sinusitis.  28dec89 pt vax 2nd hepta B. Treatment was initiated w/ PCE Dispertab & Augmentin. pt devel hives on 19jan90.  See worm...
Patient complained of pain at injection site of the left arm. He mentioned that he can't move his arm normally and had to do physical therapy. It has been an ongoing pain and affect his normal life.
This spontaneous report as received from a office manage refers to a 78 year old male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 17-JUN-2009, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneous (lot number and expiration date not reported) for prophylaxis. On 24-MAY-2017, the patient experienced a "chicken pox-like rash." On an unknown date, the patient was seen by a dermatologist (no details available). The outcome of rash vesicular was reported as recovered/resolved. Additional information has been requested.
Patient received Moderna on 05/10/2021.  Patient stated that approximately 2 am on 05/11/2021 he started to experience pain in left calf.  When patient awoke that morning left calf was red and swollen.  Patient was sent to medical facility for US to rule out DVT.  Blood clot noted and patient was sent to ER>  Patient was sent home.  Appt made with Dr., vascular, for 05/12/2021 at 10:30 am.
Sudden Infant Death preceeded by nasal congestion and dry cough. Per autopsy F/U 3/27/02: The pleural surfaces are smooth and glistening with petechiae (thymic, epicardial and pleural). There is hemorrhage within the periadrenal fat of the bilateral glands. According to the parents, they awaken with the decedent in bed with them and not breathing. They call 911 and began CPR. EMS arrived and CPR continued en route to the hospital. Efforts at resuscitation were continued in the ER, but they were unsuccessful. The infant was pronounced dead at 6:30 AM on 12/1/01.
The next day, I began getting body aches and  a sore throat. Then had low grade fever of 99.0 that evening. Sore throat worse. Body aches.
On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the touch. There is a sensation of warmth and feeling "full" in this area. At this time, no treatment has been taken as it is not uncomfortable. It is 1:45pm, and all symptoms are still present. The warmth sensation has slightly increased throughout the day. I have had bouts of chills throughout the day, but no fever or headache.
ARM HURT; FELT TIRED; LITTLE NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced arm hurt, felt tired, and little nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and felt tired, and the outcome of little nausea was not reported. This report was non-serious.
7-19-2021, five hours after receiving the vaccine, her mother states she developed a "severe headache" and vomited.  7-20-2021, in the afternoon, mother states patient became dizzy, passed out, hitting chin on concrete floor and became unconscious.  Mother drove patient to ER, mother states that it took 20-30 mins before she regained consciousness.  Patient was released from ER and followed up with PCP the next day.
The patient's child received chickenpox vaccine on 07/18/2001. The patient broke out with chickenpox on 07/22/2001. By 07/26/2001 the patient was covered head to toe and by 08/01/2001 scabbed over. The patient believes she touched the area of immunization on her child and got contaminated because the area was wet.
Case previously recorded as MA2009-4585. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse events was reported. Reference no: NA09-008308.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-AUG-2014, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (HSA) (lot # H014991, expire date 31-AUG-2014, strength: 0.5ml, dose: 0.5 ml; route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the highest recorded temperature of -14 centigrade degree. The total cumulative excursion time of the second time was 80 hours with the highest recorded temperature of -13 centigrade degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional  information has been requested.
Uncontrollable crying for 2 1/2 hours. Also had uncontrollable leg jerking.
This spontaneous case reported by a consumer, describes the occurrence of uveitis flare-up in an elderly female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Co-suspect product included Humira (adalimumab), solution for injection, for an unknown indication. No medical history reported. In 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. April 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient took Humira (adalimumab), unknown route; at an unspecified dose. On an unknown date, patient experienced uveitis flare-up (medically significant), back pain and pain in extremity (pain in arm). At the time of the report, uveitis flare-up, back pain and pain in extremity (pain in arm) outcome: unknown. Unknown if patient was enrolled in COVID-19 vaccine trial. No concomitant medication or treatment information reported.
Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Fever 99.5 for ~2 hours, extreme clumsiness/lack of full control of appendages, muscle aches, and fatigue all day. Sore arm (injected arm), intermittent headaches. At 10pm: swollen lymph node (size of cherry tomato of injected arm). For the next 9 days: arm tingling, as if nerve(s) were pinched, when trying to extend or stretch straight (injected arm) Symptoms caused fair/tolerable discomfort, but not severe.
This study case was received from the investigator in a trial on 23 January 2014. A 24 year-old male subject had received the following vaccines on 07 January 2014: ACAM2000 (lot number, route and site of administration not reported), anthrax (manufacturer, lot number, route and site of administration not reported) and typhoid (manufacturer, lot number, route and site of administration not reported). On 13 and 14 January 2014, the subject experienced two episodes of chest pain during exercise. The subject took ibuprofen per os once prior to physical training on unspecified date. On 14 January 2014, the subject had a normal Troponin and on 15 January 2014 had a normal ECG. The subject was referred appropriately as myopericarditis could not be ruled out. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of chest pain was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.
Patient was observed for 15 minutes after vaccination with no adverse effects during that time period.  Patient experienced  throat closing, tightness in back of throat, dizziness, light headedness, heart racing approximately 20 to 25 minutes following vaccine. Adverse effects were sudden in onset. Patient was in her car when adverse event started. Patient called 911, ambulance arrived, EMS administered epinephrine IM. Patient was given 50 mg of diphenhydramine orally 30 minutes after event. Patient reported no breathing issues within 3 minutes of epinephrine. Patient reports no other problems following that except for feeling jittery.
1 wk p/vax pt devel fever & rash to face, extending to chest, back, arms & legs;flares up when pt in car or out in the sun;saw MD who drew blood work (pending) & tentative dx of rubella
CRT transfer customer who reports that an adult patient at their office was accidentally administered a pediatric dose of RECOMBIVAX HB. Consent given to follow up. She is requesting information on revaccination. No PQC. No additional information.; This spontaneous report was received from a Nurse and refers to a female adult patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 17-JUL-2023, the patient was accidentally vaccinated with a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 0.5 mL (lot # W016842, expiration date: 19-NOV-2023) (route of administration, anatomical location not provided) as prophylaxis (incorrect dose administered).     .
not feeling well/is not feeling so good; legs are aching; she may have a mild fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well/is not feeling so good), PAIN IN EXTREMITY (legs are aching) and PYREXIA (she may have a mild fever) in a 69-year-old female 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 21-Jan-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 26-Jan-2023, the patient experienced MALAISE (not feeling well/is not feeling so good), PAIN IN EXTREMITY (legs are aching) and PYREXIA (she may have a mild fever). At the time of the report, MALAISE (not feeling well/is not feeling so good), PAIN IN EXTREMITY (legs are aching) and PYREXIA (she may have a mild fever) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication were reported. patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that, patient was usually very healthy and strong, but it seems like this time she was affected by the vaccine. She had received all Moderna COVID-19 vaccines previously and had never had any side effects. However, caller stated that she was not feeling well. Her legs were aching, and she may have a mild fever. Usually with her, even if she gets the flu, she may be achy and feverish for a couple of hours, but after that she starts feeling normal again. But this time, she was not feeling so good. Caller also stated that if she ends up taking off due to not feeling well tomorrow, it will be the first time in 17 years that she had done that. She usually never gets sick. patient had not taken any medications for her symptoms.
itchy upper arms and neck,  tongue felt enlarged- resolved after a few minutes - evaluated by paramedic
I had a headache; myalgia; dizziness; fatigue; supraclavicular lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 15:00 (Lot number: ER2613) at the age of 31 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Apples" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "allergies: Avaguard" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Betadine, reaction(s): "allergies: Betadine". The following information was reported: HEADACHE (non-serious) with onset 15Jun2021, outcome "not recovered", described as "I had a headache"; MYALGIA (non-serious) with onset 15Jun2021, outcome "not recovered", described as "myalgia"; DIZZINESS (non-serious) with onset 15Jun2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 15Jun2021, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 15Jun2021, outcome "not recovered", described as "supraclavicular lymphadenopathy". Therapeutic measures were not taken as a result of headache, myalgia, dizziness, fatigue, lymphadenopathy.  Additional information: After vaccination, I had a headache, myalgia, dizziness, fatigue for 3 days and the symptoms went away. I figured out today that supraclavicular lymphadenopathy is noted on the left side. I am not sure since when it happened. No covid prior vaccination. Not tested covid tested post vaccination  No follow-up attempts are possible. No further information is expected.
25 weeks and 6 days, due 8/8/21, birth weight unknown. Adverse effects: fever, body aches, joint pain
Headache, SkinRash, NauseaVomiting, SOB, chills, facial rash, nausea, headache Narrative:  Other Relevant History:
Immediately after receiving the 2nd injection child stated that "her tongue hurt and she felt dizzy". No tongue swelling or uvula swelling noted upon exam but patient was laid down and she passed out for less than one minute. Patient also became pale and diaphoretic. EMS was called and we continued to monitor child and she did have some slight wheezing but no difficulty breathing and wheezing cleared in 2-3 minutes. BP was 82/40. EMS arrived and assessed patient - she was then ambulatory and was alert and talking. Patient departed to Hospital per EMS at approximately 10:45am with mother at her side.
whole body had blood red blisters and rashes; whole body had blood red blisters and rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 15:00 (Lot number: FL0007) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: BLISTER (non-serious), RASH (non-serious) all with onset 11Dec2021 06:00, outcome "recovering" and all described as "whole body had blood red blisters and rashes". The event "whole body had blood red blisters and rashes" and "whole body had blood red blisters and rashes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of blister, rash. Patient received Prednisolone for the treatment of events.  Additional info: No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.  Follow-Up (29Dec2021): Follow-up attempts are completed. No further information is expected.
injection site is really hot; injection site is bruised; injection site is dark; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site is really hot), VACCINATION SITE BRUISING (injection site is bruised) and VACCINATION SITE DISCOLOURATION (injection site is dark) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     It was reported that patient had no allergies.  Patient never had COVID positive test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No medical history reported by the patient.     On 12-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site is really hot), VACCINATION SITE BRUISING (injection site is bruised) and VACCINATION SITE DISCOLOURATION (injection site is dark). At the time of the report, VACCINATION SITE WARMTH (injection site is really hot), VACCINATION SITE BRUISING (injection site is bruised) and VACCINATION SITE DISCOLOURATION (injection site is dark) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications information was reported.  The patient never experienced similar event in the past. AE did not cause patient to seek medical care. There was no change in the symptoms.   No treatment medications were provided.
Information has been received from the registered nurse concerning to an approximately 68 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 22-DEC-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.