chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Young girl died from the Moderna vaccine after her second dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Young girl died from the Moderna vaccine after her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not provided.  Treatment information was not provided.  Company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of death. The event occurred on an unknown date after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of death. The event occurred on an unknown date after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Fever. Injection area hot. Inflammation and redness moved down the arm. Dr. prescribed 1 week worth of cephalexin, beginning 6/7/13. As of 6/13/13, patient feels fine and infection has cleared.
This spontaneous report was received from a pharmacist referring to a newborn patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated concomitantly with two doses of RECOMBIVAX HB (strength, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. No adverse events were reported. Additional information has been requested.
Patient received H1N1 vaccination Friday Oct 30 night and developed rash and itching generalized on Saturday. On Sunday, developed nausea, diarrhea and vomiting.
Fever. (to 103.0 F) Vomited repeatedly, Fatigue. No Diarrhea, no rash. Treated with antipyretics, and zofran. Symptoms resolved within 24 hours of visit on 09/14/2022
Although I'm reporting the adverse affects from the 2nd dose of SHINGRIX, I had the same affects from the first dose in October. The affects from the 2nd dose were slightly worse. Since Friday evening, December 7, I've had a temperature of 100.2, nausea, headache, sharp pains in my head, aching and weak joints, muscle pain all over, skin hurts to touch (all over), dizziness, and swelling, redness (approximately 2.5" diameter) and extreme tenderness at injection site. As of now, noon on Sunday, symptoms are thankfully fading.
I started feeling a headache around 9:00 P.M. Eventually around 11-12:00; I started experiencing body aches and chills. Eventually in between the hours of 12:00 A.M. to 4:00 A.M. I started a fever. I dealt with varying degrees of the previous stated symptoms throughout the day with varying effectiveness with OTC Tylenol. On Friday, most of the symptoms had dissipated, however I did experience random bouts of hot flashes.
Arm swollen 2X NL size, Red, hot vesicules around injection site had given Benadryl in ER.
48F with PMH of cystic fibrosis s/p BLTx 2012, HTN, chronic sinusitis, and transaminitis, who presents with low grade fever, nausea, vomiting, unable to tolerate PO x1 day. Found to have +COVID, given monoclonal antibodies and symptoms resolved by discharge  #Fever, nausea, vomiting, headache Patient reported nausea/vomiting x1 day, tried to eat crackers and minimal liquids, unable to tolerate PO and was nervous about not being able to keep down transplant medications, therefore presented to ED. Also with associated headache and noted fever with Tmax 100.3F, improved with tylenol. On admission, nausea improving with PO zofran and continued home PPI. Hyponatremic (Na 129). Given NS 500 cc bolus for hydration. Empirically given IV Ceftaz 2g x1 for immunocompromised with fever. Blood cultures x2 with NGTD. Found to be +COVID as noted below, GI sxs likely related to viral infection. Improved at discharge, given Rx for PO zofran to use at home.   #COVID Found to be COVID+ on admission. Afebrile, no URI symptoms, satting well on RA. CXR with no acute findings. She had COVID last year (no symptoms, tested due to exposure to coworker) and was also vaccinated x2 (Pfizer) but had not yet gotten booster due to significant reaction after both vaccines and wanted to test antibody level first. Given mAb (12/1) for prevention of worsening infection, tolerated well without complication. Did not meet criteria/require dexamethasone or Remdesivir.
Injection site is very sore like a big bruise upper left arm. Big toe right foot GOUT. I take Allopurinol 100 mg for that
Fridge temp went out of range by 4 degrees overnight sunday due to storm, closed on 1/17. Vaccines were administered to patients in the morning
Initial report was received 25 May 2011 from a health care professional. A 29-year-old male patient who had no past medical history, had received a first dose intramuscular left arm injection of ADACEL, lot number U3872BA (sanofi pasteur, Ltd lot number C3827) on 10 May 2011 as part of wound management treatment for a head injury. On 13 May 2011, three days after vaccination, the patient developed right sided facial numbness and tingling, with numbness and tingling of the right hand, and fingers of his right hand. He also experienced fatigue. On an unspecified date, the numbness, tingling and weakness then spread to the left side of his face, and to his left hand and foot. The patient received a neurological consult with negative exam findings. A CT scan of the head was negative. On 25 May 2011, his symptoms were beginning to resolve (also reported as subsiding) and had mostly disappeared. The patient had no concurrent illness and he had not received any other vaccinations within four weeks of ADACEL. At the time of the report, outcome was not recovered. Documents held by sender: None.
One week after receiving first shot, just below the injection site started itching bad; red rash; swollen; warm to touch; approximately 5 inches round.  I had been taking penicillin and augmentin in January for an abscessed tooth.
Fever; chill; headache; body aches; sweats; This is a spontaneous report from a contactable consumer reported for himself. A 46-year-old male patient received his 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) at single dose via an unknown route in left arm on 15Feb2021 08:15 AM for Covid-19 immunization. Medical history included vitiligo. No allergies to medications, food, or other products. Concomitant drug that patient received within 2 weeks of vaccination included Vitamin D 50,000 IU once a week. Historical vaccine included 1st dose of PFIZER-BIONTECH COVID-19 VACCINE (lot number: EL3247 on 27Jan2021 10:00AM in left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 12 hours after injection (on 15Feb202108:30 PM), patient experienced adverse events of Fever, chill, headache, body aches, sweats.  No treatment received for the adverse event. Outcome of the events was resolving.  Since the vaccination, the patient had not been tested for COVID-19.   The report was considered non-serious.
Patient was given 0.5ml instead of 0.25ml, no reaction noted and no complaints letter was sent to patient informing of dosage given
Tender swelling involving the right arm (deltoid area) extending down to the lower arm below the Right elbow joint. Warm to touch with reduced range of motion at the elbow joint.
Breakthrough case admission after 2 vaccines Moderna 12/30/22 lot# 026L2-0A;  Moderna 1/27/21 lot# 029L20A
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L020861, expiration date 25-JAN-2017; lot # M002252, expiration date 28-FEB-2017; lot # L023870, expiration date 20-APR-2017; lot # M004885, expiration date 23-OCT-2017 (dose was not reported, orally). The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a date logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received PPD .5cc IM left deltoid - was to have received Tdap instead. Called for recommendations told that "no adverse effect was expected.
This patient was given a dose that was expired. The ActHib vaccine had expired on 3/7/21 and it was administered on 3/8/21. There were no adverse symptoms observed. The patient has been notified and scheduled for a new ActHib vaccination.
a 3 month old patient was injected with Quadracel in error,No AE; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case from a consumer (office staff).  This case is linked to case 2020SA182003 (same reporter)  This case involves a three month old female patient who was injected with 0.5 mL first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], vial once (lot number: C5688AA, expiry date: 26-Nov-2021) via intramuscular route in the left thigh for prophylactic vaccination on 08-Jul-2020 in error.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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
Patient is a 82 y.o. male with a history of Hypothyroidism, BPH, Anxiety, and Osteoarthritis who presented to RMH 9/23/2023 with worsening shortness of breath for 2 days after he tested positive for COVID. In ED: required BiPap.     1. COVID-19: Vaccinated, on Paxlovid prior to admission. Symptoms started on 9/19/23 (3 days prior to admission). SARS-CoV-2 positive on 9/20/23. CXR 9/23/23: non-acute. Blood cultures 9/23/23: no growth to date. CT chest 9/25/23 seems more consistent with bilateral lower lobe pneumonia and pulm started CAP abxs as bellow. Supportive care. Weaned off oxygen 9/29/23. No need for further steroids. Isolation completed 9/30/23. 2. Acute Hypoxic Respiratory Failure: Not on oxygen prior to admission, required BiPap 18/10 in ED due to above, weaned to HHF on 9/23/3034. CTPA 9/25/23 with small segmental PE and concern for consolidations RLL worse than LLL. Anticoagulation started, abx started. Home o2 eval 9/29/23 and weaned to RA.  3. CAP: Per ct as above. Rocephin azithro started. Abx through 10/1/23 transitioned to omnicef on discharge. 4. Pulmonary embolism: In setting of covid and pneumonia. LEVD negative. Heparin gtt started, transitioned to eliquis 9/27/23. Continue for 3 months for provoked PE in setting of COVID.
Bilateral Pulmonary embolism based on CT chest, symptoms started after 5-6 days of J&J COVID vaccine. Possible pancreatitis
No Adverse Event; Accidentally administered a 0.5mL dose of the Moderna COVID 19 bivalent vaccine to a child; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Accidentally administered a 0.5mL dose of the Moderna COVID 19 bivalent vaccine to a child) and NO ADVERSE EVENT (No Adverse Event) in a 6-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Patient had no allergies.     On 21-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) .5 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL OVERDOSE (Accidentally administered a 0.5mL dose of the Moderna COVID 19 bivalent vaccine to a child). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, ACCIDENTAL OVERDOSE (Accidentally administered a 0.5mL dose of the Moderna COVID 19 bivalent vaccine to a child) 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 OVERDOSE (Accidentally administered a 0.5mL dose of the Moderna COVID 19 bivalent vaccine to a child).    Not on any concomitant medications. Patient accidentally got a 0.5mL dose of the Moderna COVID 19 bivalent vaccine instead of 0.25mL dose. No treatment medication was provided.
no adverse event; The patient was inadvertently administered a dose of MMR II (Lot#N024696/Exp: 4/7/2019), on 4/9/2019, that was expired.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 09-APR-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), lot # N024696, expiration date 07-APR-2019 for prophylaxis (dose and route of administration were not reported) (expired product administered). No adverse effects reported. The outcome of expired product administered was not reported.
Cloudy left eye, saw Dr determined the problem. Have an appointment at Eye Physician,  Dr. on July 26 th at 1pm.
Patient reported the event on 10/16/19.  The TDap was administered on 10/1/19. Patient stated that her left arm is swollen an has a knot feel to it.  She ran a fever off and on for four days.  She still has a stuff nose, throat swollen, and her left arm is still hurting and is swollen.
13x13cm area of erythema, mild low grade fever. Pt presented to ED 2/1/19 9:29pm with above Sx's. Ibuprofen 176mg given to pt in ED. Pt F/U in clinic 2/2/9, continued large (L) thigh erythema, "remains within outline made in ER yesterday." At 2/2/19 appointment, mother of child did confirm that two immunizations were given in the (L) thigh and two immunizations were given in the (R) thigh. While rooming the patient I did visualize two injection sights on (L) thigh and two on (R) thigh. During the rooming process, pt's mother stated she had a similar vaccine reaction around pt's current age.
Case  + in January 2021, received both Pfizer doses in April 2021 then became infected again + June 2021. Was hospitalized for GI bleed and tested + at that time.
I began experiencing symptoms of COVID-19 on 1/24/22 with chills, fever, congestion, cough, fatigue, headache, body aches, shortness of breath, oxygen levels dropped into 80's 1/28/22. I tested positive 1/25/22 and experienced symptoms for 10 days, but the fatigue and shortness of breath lasted for 4 weeks. Was prescribed antibiotics, steroids, and decongestants while ill.
Neck is sore and hurts; Headache; 101.0 F temperature; Body aches; Nauseous; After the vaccination, she felt a little sore; A spontaneous report was received from a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt a little sore, her neck is sore and hurts, has a headache, a 101 F temperature, body aches and feels a little nauseous.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, after administration, the patient felt sore.  On 06 Jan 2021, the patient stated she feels "more sore", her neck is sore and hurts. She has a headache, and a 101 F temperature. She mentioned that she hardly runs a temperature when sick. Upon call back, she reports that she still has body aches, pain, and feels a little nauseous. No treatment information was provided.   On 06-JAN-2021 laboratory details included body temperature which was 101°F.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for events, felt a little sore, headache, a 101 F temperature, were unknown.   The outcome for events, her neck is sore and hurts, body aches and feels a little nauseous, were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Within minutes, flushing, increased HR sensation throat closing given DEPO-MEDROL.
Dizziness, some loss of balance, low grade fever of 99.8 F, chills, body aches and mild diarrhea that lasted for 3 days. And a persistent, dry cough that started 2 days following the vaccine shot and persisted for 5 days.
The patient presented with ITP on June 30th, 2022 which started a couple of weeks before the visit. She was stable and treated with steroids. Sx resolved. She did test positive for COVID a couple of months earlier per history.
"put him to bed for 4 days"; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced movements reduced. On an unknown date, the outcome of the movements reduced was recovered/resolved.   It was unknown if the reporter considered the movements reduced to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's ex-wife. The patient received his 2nd dose of Shingrix and was in bed for 4 days. The lot and expiry date was not provided. The report did not consented to follow up. This case has been linked with case US2021AMR124573, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR124573:Same reporter, different patient (invalid case)
Fever over 104, vomiting, back pain, not lucid at times, loss of appetite, fatigue.
Severe headache, joint pain, swelling of lymph glands in arms & neck side of booster, swelling, redness & pain @ injection site, ringing in ears.  Symptoms.  6 days
Information has been received from a physician concerning a 32 year old female who on 07-MAR-2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #0211U) and a second dose on 30-MAY-2007. On 18-AUG-2007 the patient began to experience neurological disturbances, generalized swelling of the body, drooping of her face, numbness of her hands, pain in her fingers, pain in her joints and abnormal thought processes. The patient called the doctor. As of 20-AUG-2007 the patient had not yet recovered. Additional information has been requested. 10/29/07-rcords received for DOS 3/7-10/11/07-Seen for routine exam and on 3/29 and 4/4/07- for breast biopsy. 8/20/07-seeing neurologist for C/O swollen face, drooping, numbness of fingers. Myalgias, arthralgias. 9/5/07-continues with neuro symptoms. Guillain-Barre has been rulled out. DX possible autoimmune syndrome with selective malabsorption.  11/7/07-neuro consult records received for DOS 8/16/07-Impression: Symptoms of paresthesia all over, unsure of etiology. Sensory-type seizure is possible.Complex partial seizures may also be possible explanation for transient episode of confusion. Neurological examination is nonfocal.
About one month after receiving the 2nd dose of the Pfizer Covid-19 vaccine, I started suffering from tinnitus, an issue I had never experienced before.  I visited an ENT for a full check up.  No treatment at this time prescribed other than learning how to deal with it.
Died 7 days after shot after shot had uncontrolled sugar levels  could not get sugar up and felt sick 2 days after and died 7days later
I was a little sore for a day or two afterwards and I did fine all summer long, but 10/08/2021 the right side of my face became paralyzed and I was talking through the other side of my mouth like I was having a stroke and so we called an ambulance. They ended up saying I had facial paralysis and then I had to see a neurologist and it could be either Bells Palsy or Ramsey Hunt syndrome. Right before it happened I possibly had shingles because I had blistering on my cheek which I thought was a reaction to makeup. When you're paralyzed your eyes are wide and I had to tape it shut at night and I couldn't drink because my mouth wouldn't close all of the way and I couldn't pucker up and I had a loss of appetite. I've mostly recovered but not totally and I still have a problem with my mouth and talking out of one side and it feels.
Rapid heartbeat 24 hours severe stomach pain two weeks muscle and joint pain two weeks extreme high blood pressure two weeks. Extreme fatigue two weeks.  The vaccine triggered an auto immune response.  It triggered a flareup in my body and I was very ill for several weeks.  Because of my severe stomach pain and blood pressure soaring my doctor ordered a CAT scan and blood work up.   I am now three weeks post vaccine and my body seems to be calming down my blood pressure has returned to normal and the stomach pain has stopped.  The extreme fatigue muscle and joint pain is still present but much better.
p/vax pt had low grade fever 100.7 R, rash all over body & itchiness;pt hosp & had a blood culture performed which were negative;dx erythema multiforme;skin biopsy planned;
Patient developed large, hard, nonpainful thyroid nodule. Workup is still ongoing, but TSH and CRP normal. Ultrasound is reassuring for malignancy. Date of adverse effect is the date she noticed it, but it is large enough that she couldn't have missed it more for than a day or two. I'm not sure that this WAS an adverse effect, but the timing seemed necessary for reporting.
Patient was sleeping with her Mom and Mom heard her make a gurgling noise. Patient became limp and both eyes rolled into the back of her head. She remained this way for about 45 seconds and finally started to cry when Mom put both of her feet in cold water. Her cry was weak and odd sounding - not her normal strong cry. Mom reports a few episodes for leg stiffness in the 2 months prior to flu shot too, but never had any seizure-like activity or episodes like the one above.
Cognitive impairment noticed after first dose of Moderna vaccine. Started forgetting things and make very simple mistakes that were not done before. Brain fog and goes blank in between.