chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an RN concerning a 12 month old female pt with no known allergies and no concurrent medications who was vaccinated, SC, in the right arm with a 0.5ml dose of MMRII. Concomitant therapy included varicella in the leg and HIB + Hep-B  into the leg. Subsequently, the pt developed an immediate reaction at the injection site. The affected area was 0.72mm X 5.3mm in size and tender to the touch. The pt was observed for 30 minutes and was seen by the physician. The mother was instructed to observe the site and report any changes. She called to report the redness had resolved when the pt got home. Additional info has been requested.
Day 8 pain in arm returned.  It is almost as swollen as it was on day 2. It is sore and there is about a 2.5 inch in diameter area that is tender and red.   Summary of the time course: Day 1 easy injection. Mild soreness Day 2 Painful arm including numbness in hand and fingers   Swollen around injection site. Movement hurts including raising arm to shoulder level.  Arm felt heavy as if it weighed 30 lbs.  wore ice pack to sleep day 3  painful arm beginning to feel less intense.  Sore injection site still  Day 4. Pain has subsided. Soreness continues but only to the touch near the injection site Day 5. Pain gone. Soreness continued but mild.  Day 6 same as day 5 Day 7 same as 5 Day 8 pain in are returned.  Sore to the touch, swelling increasing.  Arm feels like a dull ache. Put a salon pas patch on injection site to reduce the pain for sleeping. Ice pack provided some relief  Day 9 same as 8
New hire was administered a bivalent booster as his second dose in his primary series instead of the Movalent. Individual received his first dose of primary series on 5/3/2022 (pfizer).
Sore arm; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included blood thinners.       This case was linked to MOD-2021-072067, MOD-2021-077195, MOD-2021-070997, MOD-2021-071416, MOD-2021-070988 (Patient Link).
vaccinated on 5/17/21 & 6/4/21 and diagnosed with covid on 8/8/21 U07.1 - COVID-19
No adverse event; Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-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 04-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.).    It was unknown patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    No treatment information was reported.
My Doc and I are not sure if it's realated to me getting COVID or the Vaccine but I got thyroditis at the beginning of April and it lasted 3 months.  Thought I would let you all know.  My doctor just had me keep up with the NSAIDs (Aleve) like I did with the pericarditis I had after COVID.  As of Mid July the thyroid pain has gone away.
CONFUSION; PARANOIA; SWALLOWING DIFFICULT; SLEEPING ALL DAY; FELT EXTRA WARM; NOT EATING; NO ENERGY; NAUSEA; HALLUCINATIONS; AUDITORY HALLUCINATIONS; This spontaneous report received from a consumer concerned an 89 year old male. The patient's weight was 104.5 kilograms, and height was 185.42 centimeter. The patient's concurrent conditions included diabetes type 2 ( insulin dependent), hypertension, and cardiac heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.The product was stored in appropriate temperature conditions and was it properly stored from receipt to administration. No concomitant medications were reported.  On 22-MAR-2021, The patient was not eating, had no energy and had nausea. On an unspecified date after 28-MAR-2021, the patient developed confusion, hallucinations, paranoia, auditory hallucinations and difficulty swallowing. On an unspecified date, the patient was sleeping all day, was confused about where he was. On 09-APR-2021, the patient felt extra warm. The patient's daughter was his caregiver, stated that the patient was mentally sharp before taking the covid-19 vaccine on 19-MAR-2021.The patient had doctor/healthcare professional office visit for not eating, no energy, nausea and felt extra warm. On 01-APR-2021, the lab test was done to see if the patient had an urinary tract infection, the results of the test were negative The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt extra warm, not eating, no energy, nausea, confusion, hallucinations, paranoia, auditory hallucinations, swallowing difficult and sleeping all day was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210419860-COVID-19 VACCINE AD26.COV2.S-hallucinations, auditory hallucinations. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder and neck pain pretty bad) and NECK PAIN (shoulder and neck pain pretty bad, sometimes the pain is as severe as an electric shock) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ARTHRALGIA (shoulder and neck pain pretty bad) and NECK PAIN (shoulder and neck pain pretty bad, sometimes the pain is as severe as an electric shock). At the time of the report, ARTHRALGIA (shoulder and neck pain pretty bad) and NECK PAIN (shoulder and neck pain pretty bad, sometimes the pain is as severe as an electric shock) outcome was unknown.            No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable. It was reporter she did not experience any side effects at all after the second shot. She went on to state she could tell if the shoulder and neck pain she experienced with the first shot was from the vaccine.    Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Followup information was received on 08 May 2021, dosage related information was updated.
12:06pm Patient felt dizziness when walking to her car after vaccination. C/O dizziness, tightness in neck. Vitals:  12:08pm 150/68 64 16 O2 99%;  12:15pm 142/58 65 16 O2 99%;  12:25pm 124/58 64 16 O2 99%; 12:35pm 122/58 66 16 O2 99%;      DISPOSITION:  12:38pm  Patient left with husband, Headache and dizziness are better.
9cm erythema and swelling with ecchymosis around vaccination site. Previous vaccination yielded pinpoint papules on trunk unsure if that was viral or vaccine related.
"Pt received first dose Pfizer, immediately c/o dizziness and sweating after vaccination at approximately 2:57PM. Pt brought to triage area, NP and on-site clinic lead notified. Pt on recliner chair and was provided water, upon request. Pt denied SOB, chest pain, and any other abnormal sxs.   V/S @ 2:57PM: BP - 125/74, HR - 82, RR - 22   Continued to monitor pt for approximately 30 min, and pt verbalized improvement to sx.   V/S @ 3:35PM: BP - 132/66, HR - 79, O2 - 98%   Pt denied experiencing any more abnormal sxs. Per NP instruction, pt okay to leave when comfortable. Pt verbalized that she is ready to leave clinic. Pt left in stable condition, stable gait. ED precautions provided."
Nurse injected the vaccine as she removed needle the employee started to feel weak and short of breath.  The employee repeated said "I am weak" and "I can't breath."  A rapid response was called, checked her oxygen level (94%).  Due to employee stating she could not breath the team gave her a dose of epinephrine and started oxygen.  Her oxygen saturation increased to 98%.  They took a blood pressure - 150/88.  EMS arrived and took her to local hospital for observation.
short-winded; muscle fatigue in my arms and thighs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short-winded) and MUSCLE FATIGUE (muscle fatigue in my arms and thighs) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPNOEA (short-winded) and MUSCLE FATIGUE (muscle fatigue in my arms and thighs). At the time of the report, DYSPNOEA (short-winded) and MUSCLE FATIGUE (muscle fatigue in my arms and thighs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 2/9/2022 I went to raise my left arm & had a very intense and sharp pain in my shoulder. After my left pinky finger, ring finger, and the side my hand and wrist closest to my little finger are partially numb. There is still a pain in the top of my shoulder. I've also lost strength in the left hand.
Eye infection with pus in the lower part of the eye; This spontaneous case was reported by a consumer and describes the occurrence of   in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
joints ache, are stiff & swollen in hands, wrists & shoulders & knees;rt side is worse;c/o still joints;knees are sore;h/a;arthralgia;27JUN96 pt reports hand are sore & stiff in mornings & a little puffiness in hands;
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-OCT-2015, the patient was vaccinated with a dose of M-M-R II, lot # L015281 with expiration date 30-APR-2017, (dose and route of administration were not provided); which was exposed to 10.9 C for 6 hours and 6 minutes. No adverse effects had been reported. This is one of the several reports received form the same reporter. Additional information has been requested.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case is linked to case 2019SA024673 (same reporter). This case involves a 14 years old male patient who received a 0.5ml dose of FLUBLOK QIV batch number: QFAA1833, expiration date: 30-Jun-2019 via unknown route in the left deltoid on 26-Dec-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Post vax, had swelling on right side of face with 2 lumps. This is a reoccurrance of a childhood problem that began in school immunizations at age 5.
they are going crazy and want peace of mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "they are going crazy and want peace of mind".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
01/18/2021-Patient became short of breath with c/o throat tightness and difficulty speaking 30min post vaccine. Given  epi 0.3mg subcutaneous,  Benadryl 50mg by mouth, placed on cardiac monitor for 4 hours with mild tachycardia post epi. Solu medrol 125mg given IV.  Sent home and then returned 38 hours later with c/o epigastric pain, nausea, vomiting and weakness.  Sent to Medical Center
Information has been received from a physician concerning a 20 week old male who on 20-APR-2007 and 28-JUN-2007 was vaccinated with the first and second oral doses of Rotateq. There was no concomitant medication. On approximately 04-AUG-2007 the patient experienced intussusception. The patient was treated in the ER with an enema. Subsequently, the patient recovered. There was no product quality complaint. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.  9/5/07 Received vax record from pcp.  Unable to read lot #s.  T/C to provider to clarify.  VAERS database updated with verbal confirmation of same.  9/18/07 Reviewed ER medical records from initial hospital which reveals patient seen 8/5/07 for vomiting, lethargy & abdominal tenderness.  Transferred to higher level of care. ER FINAL DX: Intussusception. 9/28/07 Medical records faxed to CDC. 10/2/07 2nd Hospital medical records reviewed which reveal patient experienced lethargy, bilious vomiting & bloody mucousy stool.  Transferred from outlying ER.  Admitted 08/04-08/05/2007 for observation s/p enema administration to reduce IS.  Progressed well & d/c to home. FINAL DX: Intussusception, air enema reduction.
"COVID Arm" with raised, itchy red blotch (approx. 4"x3") at/near injection site appearing at day 8 following injection. Treating with antihistamine (Zyrtec) and gradually fading but still red (visible) on day 11 following injection.
Within 10 minutes pt had tingling of lips and started itching all over; Given 50 mg oral Benadryl; Transported by EMS to Emergency Department; pt reports she was given epinephrine in the ED; Reports her B/P was 160/120 and pulse was 130 in ED; Reports she was kept in ED 3-4 hours and then discharged
Swollen, tender contusion at vaccine site. Fussiness, loose stools, decreaed appetite for 1 week. Refusal to walk for 48 hours then walking fine.
After 10 minutes post administration, patient felt lightheaded, dizzy and sweaty. Patient then fainted and was conscious again within 10 seconds. Blood pressure went up to 132/85. Patient was given water and snacks. She was instructed to sit an additional 30 minutes to see how she felt.
3-4 days after the vaccine, the patient developed severe stabbing pain in the hands and feet followed by worsening numbness in the hands and feet with weakness of the hands and trouble with her balance
1 week after shot broke out in hives,,,its been 6 days so far of hives
Case died of Covid after completing the Covid vaccine series.  Patient is a 75 y.o. female with a history of OSA, afib, COPD, who presented to the ED after being found down at home. Was last seen by friends on Saturday (3 days ago). Was found down by neighbors Tuesday (10/5). She had some altered mental status on presentation and tested positive for covid in the ED. CXR with findings suspicious for COVID pneumonia. She does have a history of a pleural effusion, but based on imaging, it looked like COVID was by far the driver for her respiratory failure. Patient's closest relative is her sister-in-law. ICU physician called sister-in-law and it was determined that patient would not want intubation or CPR. The admitting physician spoke with sister-in-law as well. She relayed that patient had been in general poor health and declining recently and had made comments indicating that she may die soon. The poor prognosis for covid patients who are intubated was discussed with sister-in-law. Sister-in-law confirmed that patient's wishes are consistent with DNR/DNI. Due to respiratory failure and hypotension, she was given a fluid bolus and high flow nasal cannula in the ED. Patient did not show any improvement. Admitting physician asked patient very clearly if she would want us to continue or treat her for comfort. She opened her eyes and yelled "comfort!" which was difficult to interpret given her encephalopathy. However, Patient confirmed that she would like only comfort measures did not want to be admitted to the ICU. She also confirmed that Patient would not want renal replacement therapy given her degree of renal failure presently. Patient was admitted to the medical floor where she remained hypoxic and tachypneic. She was supported on comfort care status and was treated with medications to alleviate her symptoms. Patient was accompanied by two of her friends at the bedside. Patient passed away peacefully at 0047 10/6/2021. Family was updated by nursing.
Pain began in back and knees.  Slight at first, hard to get up from sitting.  Substantially worse over next two months, and gradually worse from then to present.  Misdiagnosed for about a year.  Diagnosed now as autoimmune.
Headache, Arthralgia, NauseaVomiting, Malaise, Chills Narrative: Lightheaded and headache day after injection. Managed with OTC meds. Had stomach upset, vomiting x1, diarrhea x1 the next day. Ate yogurt and drank Gatorade.
Patient concerned that pain did not go away within a couple of days. Still warm to the touch and sore. These symptoms are getting better and not worse.
A pharmacist reported that an unidentified person received Prevnar vaccine. The pharmacist "thinks" the pt did have a seizure following the injection of Prevnar. This case is considered serious since convulsion was considered medically important in this case. No additional info was available as of the date of this report.
Lightheaded, dizzy, shakey, nausea, unable to look at any screens
minimal symptoms; This spontaneous case was reported by a patient and describes the occurrence of ILL-DEFINED DISORDER (minimal symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 ILL-DEFINED DISORDER (minimal symptoms). At the time of the report, ILL-DEFINED DISORDER (minimal symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Patient stated for the first dose the vial was swirled, then drawn up, then administered.   No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-028598 (Patient Link).
Invalid vaccine was administered (stored for 22 days in the freezer- 5 days more than recommended freezer shelf life), Pfizer recommended that we administer a booster shot on the opposite arm, no wait time between doses is required.
Employee states site started itching Saturday, 1 day after getting   varicella vaccination. States she has been getting spells of chills and sweats, diarrhea since Saturday. Redness and swelling at injection site. No fever today. She has been putting hydrocortisone on injection site.
Large, swollen red patch at injection site. Redness lasted 1 week. Still having residual mild pain and itching 2 weeks later.
Malaise, redness L arm near injection site, swollen neck glands, few small red itchy bumps on back.
G62.9 PERIPHERAL NEUROPATHY 8/6/2021 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT G62.9 PERIPHERAL NEUROPATHY 8/6/2021 COVID-19 DISEASE
Patient had reaction from TDAP - H/A, stiff neck, body aches all over, fever of 100.5 lasted 6-8 hours.