chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received moderna vaccine on 1/6/21, 2/3/21, and 11/4/21. Presented to ER on 1/9/22. Found to be COVID positive on 12/24/21. Admitted to hospital. She has had progressive decreased p.o. intake, but she continues to take her  medications, which include diuretics.  She does have a history of CHF with  ejection fraction of 35% to 40% and grade 1 diastolic dysfunction.  She came  to the emergency room complaining of generalized weakness and fatigue and  decreased p.o. intake and her creatinine was found to be bumped up to 2.0 from  her baseline of 1.0, potassium was 4.7.  She denies any fever, chills, or  cough.  No chest pain.  No shortness of breath.  No nausea, vomiting,  diarrhea.  She is saturating 93% on room air.  However, her H and H and  platelets are lower than before.  She is on medications for her Waldenstrom  macroglobulinemia, which I am going to hold and consult Oncology in the  morning.  She denies any bleeding issues.  She will be admitted as an  inpatient and she will be a full code.She was being treated with antibiotic therapy as well as Decadron.  Was stable on 2 L however on 01/17/2020 to her respiratory failure did worsen requiring high flow nasal cannula and this morning had to be increased to 15 L on high-flow.  Previous CT did reveal findings of COVID pneumonia.  With her worsening respiratory failure as well as the recent passing of her husband earlier this month, patient did change her code status to do not resuscitate and now has agreed to proceed with comfort care measures.    Given her worsening oxygen requirements discussed goals of care again with the patient as well as son who was present at bedside.  Patient states that she would like to be comfortable and agreed to proceed with comfort care measures. initially started on p.r.n. morphine, Ativan as well as scopolamine patch   Palliative care and case management consulted, Gradually decrease oxygen and  Plan to discharge to NH with hospice but patient developed respiratory distress and required Morphine drip, patient passed away at 1/21/22 at 05:59 AM.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. on 05-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
experiencing hives for 5 1/2 weeks and they keep coming, breakthrough hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experiencing hives for 5 1/2 weeks and they keep coming, breakthrough hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (experiencing hives for 5 1/2 weeks and they keep coming, breakthrough hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and HYDROCORTISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (experiencing hives for 5 1/2 weeks and they keep coming, breakthrough hives) outcome was unknown.            No Concomitant product use was reported.  The patient received the booster dose on 16-Nov-2021 and then 8 days later the patient have been experiencing hives for 5 1/2 weeks and they keep coming. The patient had found the most effective thing to help with the hives was Zyrtec once a day. The patient had previously tried Allegra, but it doesn't work as well, and hydrocortisone cream did help some. The patient had breakthrough hives. Reportedly, the patient had seen an allergist and they had seen a lot of people with hives. Patient states there is a ton of people approximately 1,000 + members that were in the group on Facebook who are primarily women around the age of 40.   This case was linked to MOD-2022-436371 (Patient Link).
Mom presented pt @ clinic on 1MAY91 w/generalized rash & t102, which had begun 30APR91 - advised to given APAP;
technician administered vaccine, within minutes pt developed stinging/burning in left arm, stated that they could not relax it.  pharmacists were notified at this time. Pt skin and face appeared red and pt was in distress.  Pt was given cold compress for arm,  and advised by pharmacists to wait additional 30 minutes.  Pt and mother (a nurse) agreed and agreed to have pt take diphenhydramine.  pt was then checked on every ~5 minutes by technician and pharmacist.  after ~45 minutes total, pt still complains of burning/arm pain but is able to move arm and denies any signs/symptoms of anaphylaxis.  I assessed pt at this time and stated they could stay as long as they wanted, but that they may leave if comfortable to do so. Upon leaving, I counseled pt and mother to watch for signs/symptoms of anaphylaxis and if they develop to go to ER immediately.  Also counseled to see a doctor if pain/burning does not resolve within 24 hours.  Also counseled could take APAP/IBU for pain in short-term.  This was all documented on back of pt's VAR
SORE, BURNING SENSATION AT INJECTION SITE. RADIATING DOWN THE RT. ARM TO MY HAND. WORSENED AND SPREAD TO DEEPER DELTOID AREA, WORSENING PAIN WHEN OUTSTRETCHING ARM. SEVERE BRING PAIN WITH MOTION OF RT. ARM. CONSULTED ORTHOPEDIC DR - NEGATIVE X-RAY. 5 MONTHS THERAPY AT CHIROPRACTOR - U/S WITH STIM, EXERCISES, HEAT. LITTLE IMPROVEMENT TO DATE.
Progressive ataxia since prior to 3/07 in pt with remote hx Langerhans histiocytosis; during this time, starting 8/21/07, received GARDASIL series with significant worsening of ataxia. 9/30/2008 Office notes received from PCP. Gardasil series given 8/21/07, 10/22/07 and 3/5/08 with no reported problems initially.  WCC 6/20/08 with worsening ataxia.  Has gait disturbance, slowed and slurred speech. PE (+) for above as well as R facial droop, pallor, reflexes 4+ with 3 beat clonus, Babinski (+). DX:  Cerebellar Ataxia, unclear etiology. Neurology referral. Seen by heme/onc consult for tx for histiocytosis 8/8/08. Worsening of balance and tremor with tx.  Chest pain resolved with reposition of PICC. Pt anorexic with wt loss. Neuro exam (+) for mild tremor, ataxia and imbalance with gait, slurred speech.  Impression:  CNS involvement with acute Langerhans cell histiocytosis causing ataxia and dysmetria Labs and Diagnostics: MRI brain (+) for atrophic corpus collosum, cortical gray matter abnormalities of the frontal lobe, and T2 signal abnormalities of the cerebellum. 10/13/08 Neuro consult received dated 6/24/2008 with DX:  Progressive Cerebellar Ataxia.  Hx of Histiocytosis X.  Anemia, presumed iron deficient. Abnormal MRI.  Pt presented with worsening gait difficulties, falling, difficulty using arms and progressive dysarthria.  Neuro exam (+) for minimal coarse nystagmus, eye tracking difficulty, brisk reflexes, dysdiadochokinesis, dysmetria, tremor, and profound ataxia. Pt emotional and tearful-?encephalopathy/frontal release syndrome. Referred to Heme/Onc.
Flu like symptoms. Fatigue, chills, fever. Lasted 2-3 days.
THE PATIENT WAS PALE, DIZZY AND EVENTUALLY FAINTED.  AFTERWARD SHE COMPLAINED OF A HEADACHE.
Starting 2 days after the vaccination, I had constant tingling in legs and feet and occasional tingling in head and face that would come and go. Three days after vaccination tingling in legs and feet became more intense and felt like pins and needles. Still had waves of tingling in head and face that came and went. Four days after vaccination had less intense tingling in legs and feet but more intense tingling in head. Again it came in waves that lasted a few seconds. Along with it I had trouble concentrating and a mild headache and fatigue. Five days past vaccination all symptoms were less intense and less frequent  but still came in waves  and included legs and feet, arms and upper body and head. Also had mild headache and fatigue. Six days past vaccination less often and less intense tingling sensation in all affected areas. Seven days past vaccination, again less intense and less frequent tingling sensation in all areas. Eight days past vaccination, tingling mainly in legs and feet and more noticeable when at rest. Nine days past vaccination, 6/28/21 tingling in legs and feet continued and I went to my doctor. The tingling sensation in legs and feet is still there as of today 7/14/21. It varies in intensity and happens mainly when at rest.
sore arm for 3 days, headache began a couple hours after and remained for 3 days, tiredness for a week including sleeping a lot on day 2, body aches first and second day, fever and chills first and second day with the second day having a lower grade fever (I took ibuprofen, 1 over the counter dose as needed, for the headache, fever and body aches on days 1 and 2 and it helped.)
itching; hives; Redness was also noted to bilateral upper extremities and trunk.; This is a spontaneous report from a contactable pharmacist. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an intramuscular route of administration in the arm right on 14Apr2021 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included NORVASC from an unknown date for an unknown indication and unknown if ongoing. On 14Apr2021, the patient experienced itching and hives during observation and redness was also noted to bilateral upper extremities and trunk. It was reported that vitals were within normal limits. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were taken as a result of the events included treatment with BENADRYL 12.5 mg and DEXAMETHASONE 4 mg per oral tablet. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itching, hives, and redness to bilateral upper extremities and trunk were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Change in menstrual cycle and no ovulation after shot. Had been tracking my cycles and everything was like clockwork. Periods were 5 days and heavy, I ovulated the same time every month. After shot periods were light, short and no ovulation.
Moderna COVID-19 Vaccine EUA - I have experienced the following : The injection site is very tender to the touch. The soles of my feet have become numb. Slight exhaustion through the first 24 hours after the vaccine.
cried for 4 hrs p/DTP shot today; pt is consolable & look OK on PE;
lt ant thigh had a bruised area about 4-5 cm on evening 22AUG94; by AM of 23AUG there was induration of reddness, warm to touch; 3PM on 23AUg93 this was 12-14cm in size; pt did walk & even run on leg;
Patient presented to the ED and was subsequently hospitalized for acute cystitis without hematuria within 6 weeks of receiving COVID vaccination.
Some would have us believe that if the reaction didn't occur in 7 days, the "vaccine" isn't the problem. Of course, when you go to an ER, the "vaccine" is never viewed as a problem. I have read otherwise, of  course, as I presume many of you have. I won't start citing these things here.  I nearly didn't take the second dose, but I thought I might have to travel in November. I took Moderna (1st illegible handwritten card looks like 0576 (maybeG?20a) end of January, then Moderna 010a21a end of February. My views on nearly everything have changed 180 degrees over the past year. Later, I saw "How bad was my batch" I'll attach a screenshot.. It looked as though my second dose was among the worst!   Well, I was d Well, a month later, I experienced the worst imaginable shortness of breath. I went back to the ER. This time, the found a major pulmonary embolism with a CAT scan. I was told they'd not seen anyone with this much blockage up and around, as was I.  I am a pedestrian/bicyclist and practice a Method. I was hospitalized over the weekend and told I'd be on blood thinner for the rest of my life.   My doctors won't hear any suggestion of "vaccine" injury. At the "follow-up" my "regular" physician found me irritating. I was rather upset by her various rebuttals. At the end of that visit, she told me I was in A fib and had high blood pressure. But, I guess my time was up. Since she made no recommendation for follow-up on either condition?
Patient experienced a silver-dollar sized red spot at the injection site 3 days post-injection. The spot was hot, itchy, and caused burning to the patient. Patient also experienced significant arm pain for days after the vaccine. Was still experiencing the symptoms when she called to report them.
PATIENT REPORTED A SMALL 3-5MM RAISED BUMP  ON ARM IN THE DELTOID REGION THAT APPEARED A FEW MONTHS AFTER GETTING THE VACCINE.  IT ITCHED AND IF SCRATCHED BECAME PAINFUL.
Pt exp a large area of erythema & induration @ the inject site p/ receiving Td;
Rash and welts all over legs, arms & crotch. Redness, heat and swelling of left arm. Prescribed prednisone and Benadryl.
Very foggy the night of the shot, general feeling of malaise. Got lost twice driving a familiar route. Fatigue. Woke up at 0200 2/25 with a 100.8 fever, chills, hot, muscle aches. The injection arm felt as if a hot poker was going through it. Long, loud gurgling in my stomach. Headache. Mostly resolved by 1400 2/25. Residual headache, fatigue, and some arm pain 2/26.
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1854) was received from a pharmacist on 17-Jul-2019. It describes a male consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took one dose of Vivotif, which was kept at room temperature for a day.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Period is affected. Very light and crampy; Period is affected. Very light and crampy; This is a spontaneous report from a contactable consumer (patient herself). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 03Mar2021 at 11:00 (at the age of 26 years old) as unknown, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. On 10Mar2021, it was reported that the patient's period was affected. She experienced very light and crampy, which was very uncommon for her. The patient's sister also had extremely heavy which was uncommon for her after the vaccine. The patient did not receive a treatment for the adverse events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.   Follow-up attempts are completed. No further information is expected.
approx 1 hour after vaccine pt reported headache with temp (had tem 99 deg) per pt mom tem up to 102 approx 4 hour after I 25-vomiting approx 2 hour after I 25
Pt developed .5-1 mm papules scattered on upper chest and anterior and lateral neck. Not pruritic or painful-not vesicular or pustular and minimal underlying erythema. Also reported UE and LE muscle weakness. Symptoms started within a couple of hours after getting vaccines.
Patient received Twinrix in May 2023 and is just coming back for his second dose today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix vaccine (1st dose received on May 2023 from lot number 2pg39 and expiry date 19th September 2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received Twinrix in May 2023 and is just coming back for his second dose today).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter reported that the patient came back for second dose today. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, CHILLS Narrative:
C/O onset fever up to 101 along with pain and redness starting 1d after injection.
On 25SEP91 mom called & reported pt devel severe diarrhea, vomiting midday 20SEP91; Pt taken to ER 23SEP91 & was given suppositories; These have had no effect problem continues;
Freezing (Freezing) during the night, then woke up with all the same feeling & symptoms of Covid
Itching at injection site; swelling at injection site; MILD PAIN at injection site; Redness at injection sie; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (MILD PAIN at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection sie) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (left side).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (MILD PAIN at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection sie). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (MILD PAIN at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection sie) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile.
11cmx9cm left deltoid. Hard, warm to touch. Treated with Keflex 250/5, 2tsp PO BID for 10 days.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, fever, nausea, swelling and erythema. On an unknown date, the outcome of the injection site pain, fever, nausea, swelling and erythema were unknown. It was unknown if the reporter considered the injection site pain, fever, nausea, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the adverse event to their provider. The patient experienced fever, nausea, swelling, redness, local injection site pain as a result missed 2 days of work.
arm pain; tired; This is a spontaneous report from a contactable consumer received from Pfizer Sponsored Program. A 70 years patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection (Batch/Lot number EN6198), intramuscular on 27FEB2021 13:00 as dose 1 single (At the age of 70 years) and dose 2 on 20MAR2021 13:00 (Batch/Lot number EP7534) for covid-19 immunisation. Medical history included anaphylactic reaction from ten years ago and never since (consumer had anaphylactic reaction in past to NSAID's and is wondering if she can take the Covid vaccine) and Gallbladder removal 5 years ago. The patient's concomitant medications were not reported. On an unspecified date, it was reported consumer had anaphylactic reaction in past to nsaid's and is wondering if she can take the covid vaccine. On an unspecified date the patient had experienced Arm pain and tired. No treatment was received. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown. At the time of reporting, the outcome of the events Arm pain and tired were recovering.  Information on the lot/batch number has been requested.  Follow-up (25Mar2021): This is a Follow-up  spontaneous report received from a contactable consumer. This consumer reported in response to Non-HCP letter sent to consumer which included that: Updated information:  Patient Age at Time of Vaccination:70 Years. Suspect vaccine administration date, route of administration and batch no was added for dose 1 and dose 2. New events were added.  Follow-up attempts completed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted event "Circumstance or information capable of leading to medication error".