chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/11/18- both vaccines given IM Left Deltoid with no adverse reaction at that time. On 12/19/18- Patient seen in our office for injection site pain on left arm. Dr. evaluated patient. Left arm injection site oval shape, firm, slightly warm to touch. The mounded area measured 4cm long by 5cm wide. No redness or discoloration noted. Pt reports symptoms started 3 days ago on 12/16/18. Patient reports that the pain is migrating to other joints on both sides of her body.
COVID-19 symptoms started on 04/02/2023 in the afternoon. I had abnormal fatigued. I felt tired and wanted to take nap which I wasn't used to . On 04/03/2023 I was sneezing, and I was fatigued. I tested myself with a home test at 08:00pm which was negative. I had chills and fever during the night . On 04/04/2023 I did another home test which was positive. I called my doctor's office in the morning at 10;00am  and did a telehealth with my doctor's partner in the practice. He prescribe me Paxlovid and advised me to hold on to Lipitor. I tested negative on 04/13/2023.  As of today I still have fatigued but I have recovered 97% out of 100%.
Very large area of swelling in arm, tender at DPT site, resolved over 1 week.
Numbness of mouth, chin, redness of neck and upper portion of chest, no SOB, no hives, sensation of warmth of face and neck. Some swelling of lips - symptoms resolved spontaneously took 25 mg Benadryl at 3:00 pm.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/12/21 and 4/9/21. Admitted to Hospital on 12/4/21. On 12/9/21  intubated and transferred to another hospital for respiratory failure due to COVID-19 PNA. PMHx HTN, Hodgkin's lymphoma, COPD, combined systolic & diastolic CHF. Developed secondary bacterial PNA and shock. Respiratory status cont'd to decline. Tx'd w/dexamethasone, pressors, broad spectrum antibiotics and therapeutic anticoagulation. Expired 12/19/2021.
States 3 days after vaccine, she developed hives, severe pruritis, needed IM kenalog and po Benadryl, given by PMD
Left Upper arm very red, warm, itchy and sore. Seen by MD who stated she should not have flu vaccine again d/t this reaction.
Persistent tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Other medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 05May2021, the patient experienced persistent tinnitus in both ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event persistent tinnitus in both ears was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No Adverse event; Patient received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose) 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 ACCIDENTAL UNDERDOSE (Patient received Moderna Bivalent Booster 0.25mL dose).    No concomitant medications were reported.  The reporter asked for guidance on how to proceed with the patient, enquiring would the patient need a new full dose or can the patient receive a half dose.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live Follow-up received includes batch number was added.
Patient is an 83 y/o woman with a PMHx of Alzheimer's dementia, HTN, and CKD III. She lives at a facility in the memory care unit. There have been multiple cases of COVID-19 so residents are being tested frequently. She tested positive for COVID-19 approx 6 days ago. She has reportedly had no fever or significant respiratory symptoms. She was transported to the ED today (1/23) due to generalized weakness, lethargy, and decreased oral intake. Patient is non-verbal at baseline due to her dementia but is typically able to ambulate and able to feed herself when encouraged to do so. Over the past 2 days she has not been eating or drinking. No reports of N/V or diarrhea. Facility has been increasingly concerned about patient and asked family to come see her. When family visited patient they were concerned about how dehydrated she appeared and how weak and frail she appears. She was sent to ED for further evaluation.  Upon arrival patient was noted to be in new onset rapid atrial fibrillation with HR in the 150s. BP has been stable. She is afebrile. O2 sat high 90s on RA. CXR unremarkable. VRAD report of head CT with no acute findings. UA with trace leuk est, 10-30 WBC, 4+ bacteria. COVID positive. Labs notable for WBC 14.97, Hgb 16.7, Na 156, K 4.4, BUN 65.9, Cr 2.2, procal 0.16. She was given diltiazem bolus and started on dilt gtt in the ED. She was given a dose of ceftriaxone and 1 L LR. Hospitalist service contacted for admission.  PT IS INPATIENT AT THIS TIME.
We received on 16 JAN 2008 via agency from a consumer the following information: A 28-year-old female patient, born on 22 JAN 1979, was vaccinated IM with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007.  At 12-13 weeks gestational age caller discovered via ultrasound that she had miscarried on 08 JAN 2008.  Company assessment: seriousness criterion: medically significant.  Causality: insufficient date (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing).  Expectedness assessment according to product information: Miscarriage is unexpected, drug exposure during pregnancy is expected after vaccination with Fluvirin.  On a case level, the case is considered unexpected.  No change in benefit-risk-ratio.  No measures necessary.  No.: NA08-00183.
Pt was given MMR-V instead of Varicella dose.  MOP reported no symptoms.
Weakness, nausea, headache, severe aches, high temp, extreme pain in an area in my spine that has screws and a cage.  I was down for 3 weeks.
Vomiting, fever (102), chills, aches, nausea, and headache
flu like symptoms; fatigue; injection site pain in her left arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia. Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included pregabalin (Lyrica).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain and fatigue. On an unknown date, the outcome of the influenza-like symptoms and fatigue were unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced flu like symptoms consisting of fatigue.   The patient also reported that the injection site pain in her left arm that lasted about a week and had resolved.  The reporter did not consent to follow up. This case linked with US2020AMR084981, US2020AMR084982 and US2020AMR084983, reported by same reporter.
The morning after: chest pain, palpitations, high resting heart rate, high blood pressure, dizziness. Continuing through present: extreme fatigue with any exertion, elevated resting heart rate, blood pressure, difficulty regulating body temperature, extreme dizziness, chest pain, palpitations. Treatment: anti-inflammatories, prednisone, pain medication.
Patient received flu vaccine and then started having severe headaches 1-2 days after receiving the vaccination.  Had vomiting 1 day and was hospitalized for treatment of symptoms. Discharge summary states photophobia. msv Discharge summary states intra cranial hypertension. msv
6" x 6" area - red, warm, swollen; intense pain from shoulder to entire arm, including axilla, fatigue Dx: aggressive cellulitis Rx: penicillin.
reporting MD, who is pt, exp acute rt temple pain approx 16 days p/vax; dx 5th nerve inflammation; loss of sensation to the lower branch nerve; neurologist dx rt trigeminal neuropathy w/neg MRI scan approx 2 wks p/vax; pt improving;
Pt described local pain after 2 hours, which progressed into shoulder pain. He had fevers and chills the night after the shot followed by no appetite.
ERYTHEMIA IN AN OVAL PATTERN 5 CM BY 8 CM AROUND INJECTION SITE. PATIENT CAME TO THE MEDICAL CENTER ON THE AFTERNOON OF 10/04/2018 AND THE REACTION WAS RESOLVING WITHOUT MEDICAL TREATMENT. PATIENT WAS TOLD TO COME BACK IF THE REACTION DID NOT RESOLVE.
Slight pain at vaccination site, not severe; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP69SS) via an unspecified route of administration in left arm on 22Mar2021 at 13.00 (at the age of 30 years) as single dose, for COVID-19 immunisation. The patient had no medical history. The patient had not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any medication within 2 weeks of vaccination. On 22Mar2021 the patient experienced slight pain at vaccination site which was not severe. No treatment was received for the slight pain at vaccination site. The clinical outcome for the slight pain at vaccination site was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
Diarrhea for 4 days. The exact symptom that I had when I had covid. Only getting worse  (My friend who got the vaccine with me has a horrific cough that he has not had since he had Covid. Only came back after the vaccine - 24 hours afterwards and its been 4 days for him since vaccination as well)
PATIENT FELT DIZZY AND NAUSEOUS RIGHT AFTER RECEIVING THE VACCINATION. SHE WAS ASKED TO WAIT 30 MINS POST ADMINISTRATION AND RIGHT BEFORE SHE LEFT WE CHECKED THAT THE PATIENT FELT MUCH BETTER AND NAUSEA WENT AWAY .
Not getting 2nd dose, not uncommon due to COVID pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that, the patient never came back for second dose.  The pharmacist had no further details regarding patient or product, She stated that, this was not uncommon due to COVID pandemic, which led to social problem. The reporter consented to follow up. This case had been link with US2021183424, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183424:Same reporter.
Pt. fatigue, weak, barely could run around during softball game, felt like legs couldn't support her. Complaining of general malaise by night. Possibly took Advil. on 6/19 got bitten by tick and blood tests were done to check for lyme disease by 7/12 started with amoxicillin treatment  but changed to doxycyline by 7/19. Finished treatment by 8/16. All lyme tests have been negative. 7/14 trouble walking, needed assistance to the point of needing crutches. 7/31 felt weak all over, even weak to breathe.  Seen by rheumatologist on 7/29. 8/16 had been feeling well for a couple of days by this time; went to college on 8/20. 8/23 had hard time walking again and got worse to the 25th so pt could barely move, paralytic pain. In September 2005 more joint pain as opposed to before that it was more weakness. As of today has been on Celebrex for 3 weeks. Has ups and downs. Pt currently being treated as if fibromyalgia.  Medic Record rec'd 11/7/05 -- additional med hx - spondylopathy. Information from Follow-up report states: The neurologist just called me back. At this point, he believes that the pt has neither GBS nor lyme. She has complained of pain (everywhere) and weakness (diffuse) for three months (begining 1 mo after Menactra), and he states tht she has "nothing" neurologically. So far, all tests - including physical exam, EMG, and LP - are within normal limits. Most specifically, she has normal strength. He will see her again and will contact me when/if he has any further information.
Hospitalized 2/6/22-2/8/22 Cough, chest pain, runny nose, sepsis, PNA, fever,
24 hours after vaccination patient experienced intussusception.  It was diagnosed 3 days later and required surgery as a portion of small intestine had lost blood supply and had to be removed. Per the surgeon that patient "crashed" either during or right after the surgery and was stabilized. Patient was on life support for 2 1/2 days after surgery. 12/26/07-records received from transferring facility for DOS 9/30/07-Presented to ED with single episode of rectal bleeding. Symptoms began suddently, abdominal pain, crampy intermittent left upper and right upper quadrant. Symptoms are aggravated and alleviated by nothing. Constipation, vomiting. Seen in ED day before. PE: lethargic, pale, hyperactive bowel sounds. mild abdominal tenderness. 4/4/08-records received for DOS 9/30-10/7/07-DC DX: Intussusception. Surgery ileium and cecum resection/ileocecectomy, ileoascending colostomy after reduction with air enema was unsuccessful. Four days ago developed vomiting, 2 days ago developed abdominal pain and irritability. No stool for last 5 days. Day before admission had thick bloody stool. Intubated and ventilated after surgery. Episodic fevers. TPN. At time of discharge tolerating oral foods.
Patient came into the pharmacy on 6/2/21 to get his 2nd dose of Pfizer vaccine. One of our technicians noticed he had vaccination cards for all 3 COVID-19 vaccines in his wallet (Moderna, Janssen, and Pfizer). We refused service on 6/2/21 due to patient showing multiple COVID-19 vaccinations and admitting that he had received all except his 2nd dose of Pfizer. He stated he needed them for travel since he traveled to various countries for work. It is not advised to receive all doses of the COVID 19 vaccines, so myself as the pharmacist on duty at the time, refused to give him the 2nd dose of Pfizer.  We had already given him the 1st dose of Pfizer as he had written on the consent form he had not received any previous COVID 19 vaccines and when verbally asked on 5/6/21, he stated he hadn't either. Upon checking system on 6/2/21, it showed he was going to various clinics and pharmacies to get the different vaccines.
1st dose: 08/09/21.  2nd dose: 08/30/21.  My monthly cycle is always the same. On time, flow, etc does not change. Since receiving the 1st vaccine, my period was a week early and the flow was spotty, then heavier than usual. This started August 20th, expected to start Aug 27th.  My cycle after the second dose, started 4 days early and was just spots of blood for 3-4 days. I still have not had a full period this month. Expected start date:  Sept 17. Spotting began: Sept 13.  I also have been waking up with minor headaches off and on since vaccination (I rarely ever get headaches).
Few problems at times of 1st dose, and no problems at time of 2nd injection, but went outside to do yard work 2 weeks later and found myself extremely short of breath with very little exertion.  I had donated blood the day before, so that might be a contributing factor, but wanted to put this on the record just in case.
Starting 5 hours after shot and lasting a total of 40 hours - headache; body/muscle ache; fever (ranging 100 to 101); vomiting
fever (high 100.9 fahrenheit); chills; nausea; This is a spontaneous report from a non-contactable consumer via a sales representative. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications was none. The patient's historical vaccine included first dose of BNT162B2 on 28Dec2020 for Covid-19 immunization. The patient experienced fever (high 100.9 fahrenheit), chills, and nausea following second dose approximately 12 hours after dose (Jan2021) and falling to normal at approximately 36 hours (Jan2021). The patient received Tylenol 500 mg twice taken for fever every eight hours. The outcome of the event fever (high 100.9 fahrenheit), chills, and nausea was recovered on Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
9/12/21: STARTED WITH HEADACHES, THEN BODY ACHES. THISMORNING SHE COULD NOT SMELL OR TASTE HER COFFEE. HAD TEMP SINCE LAST NIGHT
After the first booster had a flush experience and was pretty red.; This spontaneous case was reported by an other health care professional and describes the occurrence of FLUSHING (After the first booster had a flush experience and was pretty red.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 025B21A and 040a21a) for COVID-19 prophylaxis.     Patient did not tested positive for Covid-19.  There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Surgery (A major surgery this year.) in 2022. Concurrent medical conditions included Drug allergy (47 medicines), Latex allergy (Latex allergy), Drug allergy (Sulfa drug allergy), Polyethylene glycol allergy (Polyethylene glycol alergy), Blood pressure abnormal, Liver disorder (Has a liver issue.) and Allergy to vaccine (Allergic to a ingredient that is in the Moderna vaccine.). Concomitant products included ATENOLOL for Blood pressure.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FLUSHING (After the first booster had a flush experience and was pretty red.). In November 2021, FLUSHING (After the first booster had a flush experience and was pretty red.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first booster.   The patient had not experienced any similar event in the past.  The adverse event did not cause patient to seek medical care.  No treatment drug details was reported.   This case was linked to MOD-2022-609280 (Patient Link).
Female, age 45. Both Pfizer vaccines in R arm. First shot 1/3/21. Second shot 1/23/21. Through Health System. No reaction to first shot. Saturday 1/23/21 - 2nd shot. 1 hour following shot and for the next few hours incredible energy, shooting out of fingers and toes, couldn?t sit still, overwhelming energy. Sunday 1/24/21 - 12 hours after 2nd shot, severe flu symptoms for the next 12 hours. Chills, joint pain, headache, fatigue, intense sensitivity to sound. Monday 1/25/21 got up, feeling fine, showered, noticed small lump in R axilla/breast region. I went to work and by noon, I asked my co-worker to look at my neck.  He rushed me down the hall to the ER.  I had severe lymphadenopathy in my R anterior neck and R axilla.  Both the ER nurse and doctor took a step backwards and said they had never seen anything like it. I called employee health and the response was that I should be happy that my body has had such a strong reaction and the symptom is on the side effects list. I got sent home. Tuesday 1/26/21. I had a pre-scheduled mammogram.  I didn?t think they would perform the mammogram, but I thought maybe the radiologist would see me and give me advice, i.e. heat/cold, NSAIDs, compression, something.  They sent me home. Wednesday 1/27/21 - I returned to work. The symptoms remained.  I was very uncomfortable and unable to wear a bra. I wore layered tank tops under my work polo. Thursday 1/28/21. I reached out to a friend of mine who is a transplant surgeon.  She called Infectious Diseases and they said the symptoms could last up to 1 month. I called employee health again and they said, ?I should be tickled, that I have had such a robust response. March rolls around and I still have severe lymphadenopathy. My transplant surgeon friend suggests I get my bloodwork done.  All bloodwork came back normal with no changes from when I had it taken October 2020. This entire time, I've also had moderate fatigue. I could work, but that was it. I would go to bed when I got home. July I get a PT script for lymphatic drainage massage. My PT measured a 3 difference from L to R. A month later it was down to ½. I discontinued PT. My energy level started to rise again. September I got a bug bite (I do not know what bit me) on my R scapula, inferior border.  My R side re-inflamed and has remained. October I got a bug bite (I do not know what bit me) at my L occiput/C1.  My entire L cervical region swelled up. I lost hearing in my L ear and got a severe migraine.
Died in sleep.  Not sick when he went to bed. Not breathing when found. No sign of puke, blood, urine or BM.