chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited pregnancy report received from a health care professional (medical assistant) on 11 Aug 2016. This case involves a 17-year-old female patient who was vaccinated with a second dose of MENACTRA (batch number U5186AA, expiration date 14 Mar 2017, dose and site of administration were not reported) via intramuscular route on 11 Aug 2016. Pregnancy information of last menstrual period (LMP) was 01-Jun-2016 and estimated delivery date was not reported. Patient's medical history and concomitant medication was not reported. Mother's health during pregnancy, specify risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. It was a case of vaccine exposure during pregnancy. At the time of this report, the patient did not experience any adverse events. Treatment for infertility were not reported. Follow up information received from health care professional on 20-Mar-2017. This case involve 18-year-old patient. Patient's smoking history, alcohol history was reported as none. Patient had two previous pregnancy, one is current pregnancy and one miscarriage. Patient had one spontaneous abortions prior to 20 weeks gestation. On an unspecified date, post vaccination, the patient had experienced viral illness and dehydration. On an unspecified date, the patient was hospitalized. Outcome of the events was not reported. Documents held by sender: none. Sender's Comments: A 17 year old pregnant patient experienced viral illness and dehydration after vaccination with MENACTRA. Time to onset was unknown. The events are unlisted with the vaccine. No medical history or concomitant medication have been reported. Additional information regarding patients concurrent medical condition, concomitant medication and medical history with previous vaccinations is required. There could be a possibility of alternate etiology for the events due to some underlying medical condition during pregnancy. Based on available information the role of vaccine cannot be assessed.
This spontaneous report was received from a medical assistant, concerning a multiple patients of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On an unspecified dates, the multiple patients could have been vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route not reported) lot # M037533 with expiration date of 17-MAY-2018. The medical assistant had no details about the excursion regarding the time and temperature but just stated that "the vaccines went out of range once." No adverse effects were reported. No product quality complaint (PQC) and data logger were involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005697: US-009507513-1702USA005698.
Pt inadvertently received 5.0cc of Flu Shield (1999-2000 Formula). One day post vax the pt developed a fever 101F, aching, nausea and vomiting. Additional information received from the physician on 06/05/2000, indicated that the pt recovered within 2 to 3 days.
Six hours after the vaccine, she started shivering.   The chills lasted 4 hours.  She also had a headache and nasal congestion.
hiccups; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HICCUPS (hiccups) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HICCUPS (hiccups). At the time of the report, HICCUPS (hiccups) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Lower leg cramps, severe that evening.  Had done squats at school 2 days prior.
lymph node in left armpit swollen and very tender; lymph node in left armpit very tender; very bad body aches; felt really cold; slightly nauseous; headache; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 22Jun2021 at 14:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 01Jun2021 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Jun2021, at 06:45 the patient experienced very bad body aches and felt really cold. The patient tried to get warm to herself and also felt slightly nauseous and had a headache, as well as a fast heartbeat. On 25Jun2021, the patient noticed the lymph node in left armpit was swollen and very tender. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of very bad body ache, felt cold, slightly nauseous, headache and fast heartbeat was recovered on 23Jun2021, after the duration of 14Hours and that of swollen and tender lymph nodes in left armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Several weeks ago I started having an extreme and painful itch in my upper left arm.  I tried to ignore it, but it is so extreme it keeps me from sleeping.  Finally, as the severity and area of my arm affected increased, I went to the Emergency Room.  The ER doctor thought that it must be symptoms of a bug bite.  That had not occurred to me before, because I had not noticed being stung or bitten, and there have been no visible bite or sting marks on my arm.  However, I have always had a more severe reaction than the average person to bees, mosquitos and sting rays.  The doctor prescribed prescription steroids and OTC Benadryl.  I have been taking these two medicines for the past 5 days but my symptoms have NOT alleviated.  Even considering my normal bad reactions to bites and stings, I should be seeing improvement if that diagnosis were correct.  Today after I was reviewing the current status of the COVID pandemic, I got my "v-safe check-in" on the phone, and it suddenly occurred to me that I am having these symptoms at the site of my COVID vaccination shots.  So I'm wondering...if it could be relevant...
2OCT91 pt recvd vax in lt arm & exp pain @ inject site; immediately that evening c/o lt arm pain down arm affecting two fingers, generalized chills, ?fever; MD recommended APAP;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unspecified dates in July 2017, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# M031574, expiration date 11-NOV-2018, lot# M037248, expiration date 21-FEB-2018, lot# N002202, expiration date 04-NOV-2019; dose and route unknown) for prophylaxis. The vaccines were stored under 35F for 1.5 hours. There was previous temperature excursion under 35F for 3.5 hours and 34F for 2 hours. The call was because of a data logger. No adverse effects reported. The storage occurred between 07-JUL-2017 and 31-JUL-2017. This is one of several reports received form the same source. Sender's Comments: US-009507513-1708USA001320.
swollen lymph nodes under left clavicle; tiredness; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EK9231) via an unspecified route of administration on his left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient had no medical history and no relevant family medical history. There were no concomitant medications. The patient worked at 12-13 different hospitals and around first responders and COVID positive patients. The patient got the first dose of the Pfizer BioNTech COVID vaccine on 28Dec and he has developed adverse events as of 'yesterday'. Reported he was tired and having swollen lymph nodes under the left clavicle, no fever or other symptoms. The patient noticed the swollen lymph nodes on 06Jan2021 when coming out of the shower. Since he worked in the hospital he asked a few Physicians about it. Mentioned he did do something with the (Public health agency name) and signed up and they sent him text messages every day to see how he was feeling the first 7-8 days. He never had symptoms that day except for pain at the site and a little tiredness post day (29Dec2020) of getting vaccine and then nothing after that. The Physicians he spoke to were only to palpate the one lymph node, it was pretty visible. He had none visible or palpated in the neck and they couldn't feel anymore there or anywhere else. He has had some tiredness today also, but no fever or anything else. He did not receive any other vaccines the same day or 4 weeks prior. Has not had any problems with previous vaccines. He was to go back for the second vaccine scheduled on 15Jan, but not sure if he should hold off. He worked with medical Devices, pacemakers, defibrillators, pacemaker devices. He does not take any medications and has not had any bloodwork. Patient was asking what should he do if he still has the swollen lymph nodes when he is due to get the second vaccine. The patient had no relevant tests done. Outcome of the events swollen lymph nodes and tiredness was not recovered, while unknown for the other event.
28OCT97 devel febrile illness @ daycare was seen @ sick visit in office on same day temp was 103.2;exam was unremarkable;on the way home had 1-2min gen tonic clonic sz;T101.8 & exam back to nl;
Initial report was received from a consumer, who was also the patient, on 03 January 2012. A 73-year-old male patient had received an intramuscular injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, date and site of administration not reported) in August or September (year not reported). Approximately 2-3 weeks later, the patient experienced itching on the fingers and toes which persisted at the time of the report. Around the end of November, the patient also developed a swollen tongue, lips and cheeks. The patient's doctor discontinued ezetimibe and VYTORIN and started the patient on LIPITOR and the swelling resolved. The patient denied any illness at the time of vaccination, other vaccinations received within four weeks of FLUZONE HIGH-DOSE and any adverse event following prior vaccinations. The patient had a medical history of high cholesterol. The patient's concomitant medications included VYTORIN, "BENATAR" and finasteride 5 milligrams (mg). The patient received an influenza vaccine annually. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Given PREVNAR 13 on 1/7/15. Developed redness, swelling, tenderness at vaccine site on 1/9-10. Worsening over time.
HISTORY OF PRESENT ILLNESS: Pleasant 78-year-old female with history of lung cancer with remote partial pneumonectomy, some element of COPD and chronic respiratory failure on home oxygen therapy. She presents with worsening shortness of breath, which started rather abruptly the day prior to presentation. On arrival to the ED she was mildly tachypneic and slightly tachycardic and appeared to be in mild respiratory distress. Her O2 had been titrated to 4 L/m nasal cannula in order to sustain SaO2 values in the 90% or above range. Patient also noted to have pallor. No hematemesis, melena, hematochezia, abdominal pain, fever, cough or known exposure to COVID. Patient reports having received her first COVID vaccination just over one 1 week ago. A hypochromic microcytic anemia, progressive, was noted with a hemoglobin of 7.4 g/dL. Patient reported that she was up-to-date on EGD and colonoscopy within the past year without findings of acute pathology or bleeding. A CTA of the chest was conducted with findings of bilateral pulmonary emboli. She denies lower extremity swelling, pain or tenderness. Patient placed in observation in order to provide palliative blood replacement therapy and commence with anticoagulation for venous thromboembolism.  DISCHARGE SUMMARY/OBSERVATION COURSE: Uneventful observation course for this pleasant 78-year-old female who presented with somewhat sudden worsening of her chronic shortness of breath and was found to have CTA evidence of bilateral pulmonary emboli. This in the setting of a progressive iron deficiency anemia without evidence of active clinical gastrointestinal bleeding. The patient received 2 units of packed red blood cells in a palliative fashion for her presenting hemoglobin of 7.4 g/dL. Posttransfusion hemoglobin was 10.1 g/dL. Concurrently, she was placed on weight-based low molecular weight heparin for full anticoagulation. I examined the patient on the morning of February 12 and found her to be nondistressed. Her SaO2 value was 96% on 4 L/m nasal cannula O2. Recall that her baseline flow rate historically had been 2 L/m his cannula. Etiology of the patient's thromboembolism uncertain. She had no clinical findings of unilateral or bilateral lower extremity swelling or tenderness. Patient noted to be a survivor of both breast and lung cancers but without known evidence of active persistent malignancy. Of interest, she had received a COVID-19 vaccine just over one week prior to presentation. I contacted pharmacy in this regard and encouraged him to report possible adverse event via VAERS. I recommended a course of rivaroxaban and provided a prescription with a VTE dosing schedule. Patient was advised to followup with Dr in 10 days.  M.D., Hospital Medicine    MD Feb 12, 2021 08:40
Mac papular mild erythematous rash on upper thighs bilaterally; fine erythematous macules on back and scattered on face and chest.
Information has been received from a physician concerning a 4 month old male who one month after being vaccinated orally with a second dose of ROTATEQ developed hematochezia.  The hematochezia resolved without requiring any treatment and the patient fully recovered.  It was noted that the patient completed the series without further adverse symptoms.  The dates of administration and lot numbers of the first, second and third doses of ROTATEQ were unknown.  Unspecified medical attention was sought, which included the patient being examined in the office.  There was no product quality complaint.  Upon internal review the event of hematochezia was considered as a other medically important event (OME).  Additional information has been requested.
Chills; Fever; Pain in the arm of the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, chills and fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the injection site pain, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced pain in the arm of the injection site for one week, she did not recall which arm. The patient took Tylenol for the pain, and it was relieved. The patient also had fever and chills, she did not recall exactly when she experienced these symptoms.  The reporter did not consent to follow-up. All information was not available.  The consumer did not want to share her address.
PATIENT DESCRIBED HAVING ONE RED SPOT ON ONE OF HER HANDS YESTERDAY (08/05/2017) AND TWO ON EACH HAND TODAY (08/06/2017). NO FURTHER COMPLAIN STATED BY THE PATIENT.
Friday evening (9/10): fatigue, muscle aches, joint pain, fever all began Saturday (9/11): major fatigue, malaise, muscle aches, joint pain, bad headaches, fever and chills, dizziness, sore throat, terrible mouth pain with swollen and red gums and splotchiness on roof of mouth  Sunday (9/12): fatigue, malaise  aches, headaches, fever and chills, dizziness, sore throat, mouth pain, swollen lymphnodes under armpits Monday (9/13): mouth and throat pain, inflammation, redness, headaches, fatigue
Patient was given dose 2 MODERNA at week 3 instead of week 4 which is indicated. Patient did not experience negative outcomes. Patient was rescheduled to receive the dose 2 MODERNA at the 4 week interval as indicated.
Continuous ear ringing/ ringing/tinnitus, terrible; Lost weight; Ear infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 69-years-old) as single dose for Covid-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 04Mar2021 for via an unspecified route of administration as single dose for Covid-19 immunization. Medical history includes anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medications included apixaban taken for anticoagulant therapy, start and stop date were not reported. The patient experienced continuous ear ringing/ ringing/tinnitus, terrible, lost weight and ear infection on Mar2021. Caller was reporting "ear ringing/tinnitus, terrible (on Mar2021)" as a side effect of the Pfizer Covid 19 vaccine. He had tried everything and went to all kinds of doctors MRI and CT scan completed. Didn't have it before he got the injection. Never had ear ringing in his life and was 69 years old. The side effect started 1.5-2 days after the second dose. Caller has no other questions about the vaccine. The patient was 250 pounds now  he was down to 225 pounds so he had lost weight (on Mar2021). Consumer stated, " he did get ear infection (on Mar2021) and took Keflex, it was all after the Covid shot. The patient underwent lab tests and procedures which included computerized tomogram, electrocardiogram, magnetic resonance imaging on 2021 and weight as 250 lbs (I was 250 pounds now I am down to 225 Pounds so I have lost weight with this too). Treatment was received with Keflex for ear infection, it was all after the Covid shot. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Vomiting, frequent bowel movements, abdominal cramping, headache, chills, fatigue, and temperature of 99.6 degrees F.
Varicella Lot #0518U 13.09 given R arm MMR Lot # 1029418 18.08 given L arm 10:40 AM T. 96-4 11:30 AM Mom returns to office with child red-itchy rash all over her body. Scalp the worse. Benadryl 1 1/2 tsp given and transported to ER. for evaluation and IV therapy.
Pt developed typical post injection soreness in R deltoid followed by redness and warmth on 4/19/03 then swelling on 4/22/03. Denied fever, nausea/vomiting, SOB, CP, throat tightness, hives, joint pain. Felt malaise, increase appetite. F/U office exam 4/23/03 as below. Tx for cellulitis initiated with Keflex 250mg qid x 10d, NSAID, ice. (+) for 6.5cm x 7.5cm erythematous R deltoid region patch with ? tenderness, induration, thickening around injection site.
Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep.  Unable to initiate movement in arm. Use other arm to help move  arm. Went to ED on post vaccine day 4.   Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.
As the vaccine was being injected into patient's arm, he started to drop forward. He had is eyes open in a blank stare. He slowly fell into my arms and his dad came to push him back into the chair. He had a blank stare on his face for another few minutes. Then his face lost all coloring and looked as if he had fainted. Then he recognized his surroundings but was confused. His confusion lasted for about 7-10 min and then he was back to normal.
About 10 hours after injection; experienced pain, stiffness and soreness in low back and hip joints including muscles in anterior and posterior thighs and popliteal areas, which became progressively worse over next 2 days to the point of having to walk slow.  Took 3 doses of 2 TYLENOL each on both days.  Today (3rd day after injection) much better, but still some on both days.  Today (3rd day after injection) much better, but still some stiff and  sore.
Employee was administered the Moderna vaccine on 12/29/2020.  Employee stated more than half of the vaccine ran out of her arm.  Employee received the 2nd dose as scheduled without incident,  Employee stated she had titres completes which showed no immunity.  CDC contacted and recommended a booster vaccine to be given and mark the 1st dose erroneous.
PATIENT WAS IMMUNIZED BY 4:42PM AND HER MOM CALLED AT 7:20PM SAYING THAT SHE HAS ITCH ON HER ARM AND HIVES BY HER ELBOW.
Pt reported lightheadedness after injection. Pt moved to floor then relocated to different medical floor 1. VSS. Water and crackers administered. Pt reported lack of symptoms but after standing symptoms returned and pt positive for orthostatic hypotension. After multiple attempts at standing and no improvement over an hour's time, CVC clinician recommended further medical follow up. Mother decided to take pt to Emergency room/urgent care. Pt released to parent's car via wheelchair.
p/vax pt devel temp 104f, decreased appetite, & drowsiness but sleeping only 15min @ time. right leg sore & warm, gave tylenol, fever broke on 6/26, also treated w/pedialyte.
very sick from both, 3 or 4 days he ran fevers and all; very sick from both, 3 or 4 days he ran fevers and all; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that about her son's experience with Pfizer COVID 19 vaccination, her husband got it, and had both shots, he got very sick from both, 3 or 4 days he ran fevers and all. Report declined; states he is fine. The outcome of event was Unknown.  Information on the lot/batch number has been requested.