chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Reporter stated that his wife and two friends tested positive for covid over the weekend. All were fully vaccinated. Reporter stated one of them took moderna. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive on unspecified date. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive on unspecified date. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recv vax & devel localized induration 1" x 3" @ area of inj painful, warm to touch & indurated;
Pt experienced dizziness, slurred speech, couldn't stand up. Ambulance called to take her in. Doesn't remember being in ambulance at 11 am. Memory came back about 3 pm.  Patient taken to  Hospital ER.
Approx 4 weeks pregnant at time of first dose on 12/28/20, approx 6 wks at time of second dose. Daughter was born at 40 wks gestation. Diagnosed with heart murmur two days old, diagnosed with peripheral pulmonary stenosis approx 1 month old, diagnosed with hypoplastic aortic arch approx 3 months old. Negative genetic testing for William?s Syndrome.
dizziness, nausea, light-headed, loss of appetite, general ache, low fever with chills lasting approximately 48 hours.
Non-tender erythematous swelling of entire anterior aspect of left thigh. Tx cold compress and warm compress.
89 year old male with a past medical history significant for hypertension hyperlipidemia coronary artery disease history of pulmonary embolism diabetes type 2, obstructive sleep apnea chronic renal failure and congestive heart failure who presents emergency department from a residential facility complaining of cough, shortness of breath fever.  Patient has had mild upper respiratory symptoms but developed increasing shortness of breath and coughing with low-grade fevers and complained of some abdominal pain when arriving in the ED
Patient received her flu shot.  She stood up so her Mom could get her shot next.  As she was standing there, she fainted.  911 was called and she was taken to the hospital to be checked out.  The family returned later in the day to inform us that the patient was fine.
pt recv vax 7SEP97 & 36hr p/vax pt exp numbness & tingling in extremities (initially thought to be GBS), weight loss (20 lb) & flu sx;pt was not hosp but was described as getting sicker;flu-like;lower extremities paresthesia;
hair loss; autoimmune disease; covid_test_result=Positive; covid_test_result=Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 14:30 as dose 1, single (Lot number: Fp4554) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 01Oct2022, outcome "unknown" and all described as "covid_test_result=Positive"; ALOPECIA (disability), outcome "not recovered", described as "hair loss"; AUTOIMMUNE DISORDER (disability), outcome "not recovered", described as "autoimmune disease". The events "covid_test_result=positive", "hair loss" and "autoimmune disease" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Positive, notes: Nasal swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reporter stated that it was not acceptable to approve this vaccine it has caused patient to have Severe hair loss and now being diagnosed with an autoimmune disease and still going to doctors to try and get help for the hair loss, patient noticed this after getting the first COVID vaccine when patient worked in hospital. Patient also know 2 young ladies my age who both just got diagnosed with Miastenia Gravis and giving it to young children is not safe either I hope someone will stop giving this vaccine it is causing more harm than good. The patient had no COVID prior vaccination.; Sender's Comments: A contributory role of BNT162B2 to event covid_test_result=Positive, hair loss and autoimmune disease cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Around one hour after injection, patient experienced fever, pain in arm of injection, malaise, symptoms better around 18 hours, but returned with same and all joints very sore/ achy: per patient symptoms better AM of 12/20/04. Did have MD exam 12/18/04 for follow up. Rest , fluids, NSIDS, RTC prn.
This spontaneous report was received from a physician via a company representative and refers to a 72-year-old non-pregnant female patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX, injection (dose, route of administration, lot # and expiration date were not reported) for prevent shingles. Concomitant therapies included sterile diluent. On an unspecified date in October 2017 (reported as diagnosed on 30-OCT-2017), the patient experienced severe shingles rash that was on the trunk of her body and spread around her belly. The patient sought a medical attention. The patient was treated with unspecified antivirals and pain medication. The varicella zoster virus (VZV) was offered but the patient declined. The outcome of herpes zoster was reported as not recovered. The reporter did not assess relatedness between the event and ZOSTAVAX.
expired dose administered; No other AE or PQC  identified; This spontaneous report was received from a medical assistant referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 19-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) 0.5 ml intramuscular in the arm, lot # S006833, expiry date 02-SEP-2020 for prophylaxis. No other adverse event or PQC identidfied. No other information available.
recipient had a metallic taste in her mouth after vaccine administration, states this had happen before with other vaccines.
THERE WAS NO ADVERSE EVENT, THIS IS REPORTING A VACCINE ADMINISTRATION ERROR. PATIENT RECEIVED MODERNA (0.5ml) 1st DOSE. THERE IS NO ADVERSE EVENT TO REPORT AT THIS TIME. NO REACTION TO VACCINE.
doses were administered from one expired vial; Administered improperly stored vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD21-128181, MOD21-128210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up includes No New Information. On 09-Aug-2021: Follow up includes No New Information.
I was already having tinnitus after the first vaccine and it eventually subsided. Then a few hours after the 2nd vaccine, my ears began ringing again but became much worse. I did not go to the doctor after the 2nd dose because they said there is no treatment after I went to them after the 1st vaccine. It had started to subside but then I contracted COVID 9 months later and it become worse again. It's bearable now but still there.
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, drug reactions and allergies were reported. On 18-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II, 0.5 ml, expiration date 29-JUN-2014 (strength, route, dose number and lot number were not reported). No adverse effects reported. Concomitant therapies were not reported. The outcome of received an expired dose of M-M-R II was unknown. Additional information has been requested.
achy, fever, headache, fatigue, chills Narrative:  Other Relevant History:
This child complains of stomach ache and he was lethargic on 01/17/01; he stopped talking on 01/19/01. Went to the ER on 01/20/01. The child complained of headache on 01/18/01. Diagnosed with encephalitis on 01/22/01. Child talking again but unable to form many thoughts; no longer counting to 10.
Started to develop rash and itching on face.  Then at 1:30 pm noticed shortness of breath, took two Benadryl but at 2 pm still shortness of breath.  Had Epipen and felt better within 10 minutes.
Patient reporting shoulder, neck, back of head pain, dizziness, white of eye completely bloodshot at the top
Patient presented with 8-8.5 cm swollen area around injection site. Tender, moderate erythema, warm to touch, there is no adenopathy, no evidence of abcess. Temp. 99 .2 at home 10-12-2005. No Temp. noted 10-13-2005 Placed on oral Keflex 1 gram  twice daily for 10 days. Pt. will follow up Monday the 17th or sooner if needed.
Very painful arm and shoulder following morning and continuing for about 4 days. Extremely tired brain fog. Continues to this day. 04/22/2021 woke-up with total hearing loss on left side, extreme vertigo & dizziness 04/22/2021 08:21 AM went to ER. (Exam for stroke, ran EKG, etc.) 04/22/2021 02:15 PM went to ENT. 05/03/2021 7:58 AM Exam: MRI Brain w/wo Cont.: H90.3 SNHL BILAT,  H91.22 SUDDEN IDIOPATHIC HL OF LT EAR. 05/03/2021 - 05/26/2021: 9 Sessions Hyperbaric Oxygen Therapy. Daily Brain Fog, loss of energy (exhaustion at times), loss of smell, taste, some stumbling, still happening to-date.
SIDE EFFECTS SINCE VACCINE 1)  March 27, 2021: Thirty minutes after first dose experienced warmth numbing sensation at injection site (left arm) that traveled from arm to shoulder, neck and left side of face cheek.  Sensation subsided within the hour; I had already left the clinic. Also experienced soreness and fatigue for the first 24 hours. 2) April 23, 2021 to present: Muscular pain and inflammation on left arm, shoulder blade and neck. This affected all daily life activities like bathing, dressing, lifting etc.   Was able to resume daily activities after one month, but area still experiences some pain and inflammation.   3) May 2, 2021 to present: Chest pain and inflammation 4) April 23, 2021 to present: Fatigue, headaches, body aches  Treatment: Ibuprofen for chest/muscular pain and inflammation, 81mg aspirin for blood clotting, minimized activity, increased rest and monitoring
On March 12, I was having issues swallowing and it was very painful. I couldn't hydrate and I had a really dry cough. I had a mild headache no fever and the occasionally sneezy. I thought I had a case of strep throat. I took a home COVID-19 test and it was positive and I was shocked. I then went to the doctor and was told to isolate, and I did. A total of 14 days later I retested and was negative. I do believe the vaccine minimized the COIVD-19 case I had.
Pt's mother reports that pt received a series of three vaccines at a primary care visit earlier in the day. Pt's family was driving on highway and witnessed pt having a "full body, arms, and head shaking" for less than 1 minute. EMS was called and pt did have a temperature 100.8°F at that time. Pt had temperature in ED of 101.8°F. Pt had not been treated with any anti-pyretics.
The patient received a J+J COVID vaccine. She stated she had a fear of needles and had fainted after receiving vaccines before. After receiving the vaccine she took a few minutes to collect herself before walking to our post-Covid vaccine waiting area. After approximately five minutes of sitting in a chair she fainted falling sideways out of the chair onto the floor and bumping her head on a shelf located behind her chair. She lost bladder control and was shaking a bit before regaining full consciousness and began crying. We called 911 and tried to keep her calm until paramedics arrived. She quickly began trying to use her phone to call someone. Once paramedics arrived they performed full check-up the results of which I am not sure. I do know that she regained composure enough to refuse to be taken to the hospital and was lucid while talking to paramedics and the store manager. Approximately 25-30 minutes after paramedics treated her she left the store.
This is a spontaneous report from a Pfizer sponsored program [IBCC (Inbound Call Center for HCPs)].  A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single on unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced limitation of arm movement on an unspecified date with outcome of unknown.
Patient got second shingrix in 11/22/2019, seen here for shingles rash on 11/29/2019
My period started two weeks early, light spotting and some cramping that lasted 3/4days
I began to feel rash on the vaccination site on my arm that was painful and caused itchiness. Caused swelling down to my hand as well. I also had major fatigue, chills, and feverish as well. 3 days later I was given steroids for the reaction, which helped resolve the symptoms completely after steroid course.
Sunday morning (2 days after vaccine) slight pain on right palm led to discovery of swollen palm (one-third of the palm). Swelling has persisted until date of reporting. Contacted Moderna who took down information and issued a case number.  Moderna stated someone from their company may or may not contact me. Indefinite as to the resolution.
Information has been received from a pharmacist referring to a 42 year old female patient. The patient had no drug reaction/allergies. On 26-AUG-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# was reported as I022262 with expired date 05-NOV-2016, intramuscular, dose was unknown) for vaccination. No concomitant therapy was reported. During the same evening, the patient experienced injection site swelling, tenderness, joint pain and chest pain. The patient did not seek any medical attention. No treatment was given and no lab tests were performed. On 27-AUG-2015, the patient, who also worked at the same pharmacy where the vaccine was administered, stated that the events "injection site swelling, tenderness, joint pain and chest pain" were resolving. Additional information has been requested.
Two weeks after administration, patient awoke to a burning sensation bilaterally above each hip. The sensation has come and gone since it first appeared and each occurrence lasts for 2 hours or more. Patient has still had symptoms as late as date of report (02/25/2018). Patient has obtained symptom relief using ice-packs on area and rest.
I?ve had severe joint pain, fatigue, muscle pain that were delayed 6 days after my shot. I have also experienced anxiety since my first shot and panic attacks. Weakness as well in my arms and legs for a month since the first shot.
mom called 30APR93 to report had taken pt to ER the previous noc w/c/o swollen, reddened & feverish lt arm & generalized body itching; no c/o temp or rash; ER staff tol this was probably a reaction to DTP immun;
10/24/21:  present to ED with complaints short of breath/dyspnea upon rest, fatigue, and cough.  Admitted for acute hypoxic respiratory failure with positive COVID test.  On 3L NC sat 92%, RR20s afebrile, mild cough noted.  Started on IV decadron, IV remdesivir, IV Levaquin (due to extensive allergies), vitamins, dulera. 10/27/21:  continues to be mild SOB, afebrile on 3L NC.  decadron changed to IV Solu-medrol 10/30/21:  Increased oxygen need to 5L NC maintain sat >88% and initiate BiPap at night.  Afebrile, RR 26-30, HR 100-110s.  Aggitated at night. 11/5/21:  improved respirations and cough, on 3-4L NC sat >88%.  changed to oral prednisone, oral fluconazole added for thrush and new onset dysphagia. 11/7/21:  increased cough, chills, Tmax 100.7, requiring 9L NC sat 90% with desat to 70% with activity.  Resumed IV steroids. 11/10/21:  Chest CT shows new bilat. pulmonary infiltrates 11/12/21:  significant SOB at rest requiring 15L HFNC with intermittent BiPap during day and continuous at night. 11/14/21:  RR40s with desat at rest to 80% while on 15L HFNC.  CXR shows new Left sided pneumothorax.  Chest tube placed and BiPap held 11/15/21: Rapid response called for patient significant dyspnea sat 80% on 15L HFNC and NRBM RR36 HR 120.  Portable CXR shows new large right sided pneumothorax with near complete lung collapse.  Patient intubated @0132 and transfered to ICU.  Family meeting held and patient made comfort care.  Terminal extubation @1640 to 10L HFNC.  Patient expired @1700.
Presents with fever. She then developed squeezing head, frontal, 9/10 in severity but not associated with mental status changes, photophobia, neck stiffness. Was then seen in follow-up by Urgent Care and noted to have leukocytosis so she was given empiric antibiotics due to her immune compromised state and referred for admission.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On unknown date in June 2018 (reported as unspecified date four months ago), the patient was vaccinated with first dose of VAQTA (route of administration, lot number and expiration date were not reported) for prophylaxis. On 17-OCT-2018, the patient was vaccinated with second dose VAQTA lot number R018775, expiration date 09-AUG-2019 (route of administration was not reported) for prophylaxis. No adverse event reported.
Similar to what happened in April, almost like clockwork, about 10 hours after receiving the shot, the first thing I noticed, I was having trouble swallowing. Then I had pins and needles and burning that started from my feet and spread throughout my whole body. After some time, the numbness and tingling was then more prominent on the left side of my body. (I had received second shot in left arm, but the booster shot in right arm, so this was strange). I had trouble breathing, don't know whether this was anxiety or a reaction. I immediately took a Benadryl and 1/2 a Xanax. It subsided after a couple of hours.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, hives, thrush, injection site discoloration and vaccine administered at inappropriate site. The patient was treated with Steroids. On an unknown date, the outcome of the injection site pain, hives, thrush and injection site discoloration were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, hives, thrush and injection site discoloration to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. The patient received a dose of SHINGRIX shot a couple of days ago from the date of reporting. The reporter was concerned because, the pharmacist gave the SHINGRIX vaccine way up in the shoulder instead of giving it lower. He felt it was way up high near the top of the shoulder and there's not a whole lot of muscle in there, which led to vaccine administered at inappropriate site. The patient complained about pain right away and hives. About 36 hours later, the patient started to have thrush at the site of the injection and skin discoloration at the injection site. She was been to a clinic twice since then to check on her symptoms. One of the physicians gave her steroids. However, she had not been hospitalized for the symptoms. The patient still had all the symptoms. The reporter would have his wife call with the reference number to provide further information. The reporter did not want to stay on the call for further questions.