chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: A 73yo male with PMH of T, Lipoma, Duputryn; s contraction, Chronic PTSD, Moderate Depression, Alcohol and Tobacco Dependence in Remission, COPD, Pain of R. shoulder joint, Chronic Low Back pain, Hyperlipidemia, Type II DM and CKD stage IIIB. On April 11, 2022 Attending Physician reported the patient had a historical Vaccine Adverse Event by Moderna Covid - 19 vaccine booster shot. The ADR was describe as four days of fever, diffused fatigue with inability to stand or walk, severe headache, blurry vision and lightheadedness
localized redness, swelling, warmth and tenderness at injection site 5 cm x 4 cm
Following the first dose of the Pfizer vaccine, about 2 days later he started having bilateral shoulder pain which progressed over the following few days to include proximal muscle weakness. The symptoms seemed to slowly improve by the time he received his second dose on 4/20 but then he had worsening of symptoms again. Symptoms included difficulty with movement of the arms for routine daily activities, difficulty ascending stair or getting out of chairs.  Pain and weakness is more severe in proximal muscles, particularly the shoulders and hips.
Pt. states that after receiving the 3rd dose of Moderna 12/06/2021, started experiencing symptoms that evening of difficulty walking, joint pain, hand pain, fever, nausea, loose stool, and headache. Symptoms lasting 3 days. No noted Primary visit/communications. (Previous 2nd dose of Moderna 04/20/2021, similar symptoms lasting 7 days, residual Symptoms remained for 30+ days)
Had blood-streaked emesis and bloody stools following vaccination prompting hospital admisison on 4/28, blood has resolved 2 days post-vaccination but continuing to have painful mucoid stools.  Ultrasound on hospital admission negative for intussusception.  Unclear whether this represents a vaccine reaction or unrelated illness, however, no other illness identified on workup during hospitalization
Sore arm in day after dose; headaches in day after dose; This is a spontaneous report from a contactable consumer. A male adult patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced sore arm and headaches in day after dose. 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. The clinical outcome of the events sore arm and headaches in day after dose were recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Evening of 4/26-  body aches, shivering cold (could not get warm with warm clothes and blankets) Day of 4/27- extreme exhaustion, shivering and sweating Day of 4/28- mouth sores, swollen tongue, sore throat, mildly tired
Patient developed an erythematous area of induration (less than 1 cm) that was sore for 24hrs. This was first noted greater than 12 hrs post vaccination.
Developed a rash/red area about 4" x 6" around injection site which began to inch after 2 days. Two weeks later still have faint red area and minor inching.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 22-MAY-2017, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced occipital neuralgia and varicella meningitis. On an unspecified date, the patient was treated by a physician for occipital neuralgia and varicella meningitis. The outcome of the events occipital neuralgia and varicella meningitis was not reported. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event varicella meningitis was determined to be medically significant. Additional information has been requested.
Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, neck, back hips, upper legs), lethargic.  Sore throat resolved within a 8 hours.  Fever resolved within 24 hours. Muscle pain still in progress 33 hours later.  Have not taken any OTC treatments because I do not want to impede the vaccine's work.
Raised, red bump on site of injection.  Later in the day, I had extreme body aches, my body temperature was not staying consistent (severe chills and sweating bullets), and no motor function in my arm.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I have received 8 Anthrax shots as ordered by the military. While with some of the shots, I have not had much in the way of adverse reactions, the last two shots I received in 2002 and 2003 have caused significant adverse reactions. Both times, I had tenderness, touch sensations (ants crawling), heat, a large rash about 4 inches in diameter and a lump at the injection site. The symptoms lasted from 2 to 4 weeks. The lump would last months. I would like to see the Anthrax vaccine be listed as Category II (unsafe, ineffective, or misbranded), or at the very least, Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).
Eleven days after second Moderna vaccine, I started getting lightheaded.  It has continued to grow worse during the past four weeks.  My tinnitus is now significantly worse (constant loud ringing), and I become fatigued easily.  Sometimes I sleep a lot, other times I cannot sleep.  I have dizziness and lighteadedness constantly.  I recently started getting tingling in my arms and numb hands.  Had a bout of tingling in my legs like restless leg syndrome.  Feel tingling in my nasal area.  I have brain fog and have a hard time working.  I am extremely weak.  Went to three doctors (2 urgent care and my primary care doctor) and my chiropractor is working with me to lessen affects.  I can only equate it to the vaccine since I have no other apparent issues they can find.  I am getting quite depressed about my overall health and well being.
pain and discomfort under the left armpit; lymph node that is irritated; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6200) at the age of 31 years as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AXILLARY PAIN (non-serious) with onset 03Mar2021, outcome "not recovered", described as "pain and discomfort under the left armpit"; LYMPHADENOPATHY (non-serious) with onset 03Mar2021, outcome "not recovered", described as "lymph node that is irritated".  Additional information: the patient said that he received the vaccine on Tuesday 02Mar2021 and he started to notice the pain on 03Mar2021 and it was worse today 04Mar2021. He said that he was fine before the vaccine and his arm was fine. He said that if he tries to make a fist it is uncomfortable and to flex his muscles in his arm. He did say that he was doing some heavy lifting the day that he received the vaccine.  No follow-up attempts are possible. No further information is expected.
The first 3 days after I had chest pain, shortness of breath , and my legs felt so heavy and weak I could not lift them to walk (I had to shuffle) EXTREME fatigue, (I used to not take naps, now I take a nap most days of the week, sore throat, easily irritated vocal cords, weakness, memory deficit, balance/gait issues, I did not have high blood pressure before vaccines, now I do and am on medication for it, Pain to fingers and hands, chronic pain is harder to manage, pain to different areas such as left shoulder, hip and hamstring
PSA levels went up substantially after the first shot, and even moreso after the second.; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 56-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 56-year-old), both as single dose for COVID-19 immunisation. Medical history included prostate cancer which was ongoing at the time of report. It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine and unknown whether the patient received any concomitant medications. On an unknown date in Mar2021, the patient's prostate specific antigen (PSA) levels went up substantially after the first shot, and even more so after the second (shot). The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event PSA levels went up substantially after the first shot, and even more so after the second was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient developed initial injection site reaction that included swelling, red, warm welt on arm. Now has extended to include swelling of face and neck.
Pt is a 59 year old male who presented to the community center for Moderna vaccination. After receiving an intramuscular shot at his left arm he began to feel numbness and heaviness in his left arm, 3-4 minutes post injection. Pt stated he had associated light headedness and fatigue. Pts vitals were taken with 140/90 BP, HR 84, SPo2 97-98 %. Pts vitals were retaken and he became tachycardia with HR ranging from 130-125. PT stated his symptoms worsened and the paramedics were called at that time. PT received 125mg solumedrol to upper outer quadrant of left gluteal area. Paramedics arrived on scene within 10 minutes of onset of symptoms. Physical - General - Anxious , sweating   Cardiac - Tachycardia, no murmurs, rubs, or gallops. Resp - clear to auscultation B/L ABD - soft non-tender, non distended, bs + in all 4 quadrants. Presyncope rule out cardiogenic vs. neurogenic causes, pt was taken to the emergency room via paramedics secondary to what was described in the HPI. Pt was taken to hospital.
Patient received pediatric covid pfizer vaccine undiluted.  NDC:  59267-0565-01
passed out; felt dizzy all day long; concussion in her head; felt very nauseous; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at single dose in Feb2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In  Feb2021, the patient experienced passed out (medically significant), felt dizzy all day long, concussion in her head, felt very nauseous, diarrhea, headache, all with outcome of unknown.  Clinical course was described as follows: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine approximately 3 weeks ago, she's scheduled for her second dose on Saturday. When she received the first dose of the vaccine she felt dizzy all day long and when she went to the bathroom she passed out and had a concussion in her head, she also felt very nauseous, had diarrhea and a headache. Her doctor told her that she passed out from the injection and then her headache was from the concussion, he recommended her that for her second dose there's someone with her because she lives alone. Patient would like to know if this dosage of the vaccine could have caused her the reaction.   Information on lot number/batch number has been requested.
Vaccine was given in left arm on 3/24/21. Had fever and myalgia x 24 hrs. No further fever. Myalgia continued for 1 more day at a lower level. Day 3, started to have chest pain. Came to Emergency room  at the night of Day 3.
sore shoulder; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) and FATIGUE (feels tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (sore shoulder) and FATIGUE (feels tired). At the time of the report, ARTHRALGIA (sore shoulder) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitants were provided.  treatment medications were reported ice pack.
Inconsolable screaming for 4 hrs p/1st DTP given; no help w/screaming was upset & wanted to be held for 4 days p/shot;
Pt was supposed to be given a Hep B vaccine but instead a Hep A vaccine was ordered and given. No adverse events at this time
provider in the office gave a 5 year old child a dose of ADACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00676275) and transmitted to Sanofi on 09-Jul-2021.  This case involves a 5-year old male patient for whom it was reported that provider in the office gave dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 06-Jul-2021, the patient received 0.5 ml once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6817BA and expiration date: 18-Sep-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported that " Caller is requesting to know what she should do and if the child needs to have another vaccination to replace it. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age".  At the time of report, no adverse event 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Nerve pain for 6 months all day; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles about seven years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt blessed that the nerve pain lasted six months but it was all day everyday. The patient stated that he/she wouldn't wish it on his/her worst enemy. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Pt on 6th day post vaccine and is having swollen glands hard to eat and drink that is more painful on one side; Diarrhea; Body aches; Chills.
PATIENT WAS UNDER AGE OF RECOMMENDED AGE OF 18. Mom said on 9-22-2022 no reaction occurred other than than the normal pain at injection sight, tiredness and headache
Client received Pfizer vaccine at 1502 without any complications/client anxiety. Client was lead to lobby for CDC recommended 15 minutes of observation. At 1508, the client fell sideways in his chair but caught himself. Client reported having hazy vision for a second. Client's skin was pale and highly diaphoretic. Client then passed out for 20 seconds. Clinic RN grabbed under his armpits to hold him in chair to prevent him from falling over. Once client regained consciousness, (1510: BP 100/85, HR 60) Client was moved to the vaccination room to lie down on the floor with his feet elevated above his heart with a chair. BP taken at 1512, 110/80. Client given 4 cups cold water to drink and 3 fun sized candy bars to eat. At 1520 BP was 110/70, HR 70. Client monitored and assisted to chair. Ten minutes in chair he was allowed to try standing. Client was able to ambulate on own without assistance. Client was monitored for 45 minutes post vaccination, no obvious signs of distress, pruritus, apnea, hives/rashes, heart palpitations. Instructed to place family member on speaker phone while driving home/ leaving clinic.
Patient felt light headed x 1 hour.  Drank H2O and laid down and resolved.  Declined ED evaluation. All Vitals within normal limits.   #21 D/cC home with instructions to return if new symptoms or old symptoms recur.
Significant joint pain in entire body (Not Day 0, Day 1-3) Moderate joint pain continues on Day 4; Significant joint pain and stiffness in entire body (Not Day 0, Day 1-3); Headache on day 1; Booster dose; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an intramuscular route of administration in the left arm on 28Oct2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimotos thyroiditis and allergy to sulfa containing medications. The patient received unspecified medications within two weeks of vaccination. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an intramuscular route of administration in the left arm on 25Mar2021 (at the age of 48-years-old) and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via an intramuscular route of administration in the left arm on 22Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation.  On 29Oct2021, the patient experienced significant joint pain and stiffness in entire body (Not Day 0, Day 1-3), moderate joint pain continued on Day 4 and headache on day 1. The events did not result in doctor or other health care professional office/clinic visit and 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 headache and significant joint pain was resolving, while that of the event stiffness in entire body was resolved on 31Oct2021.
Morning after injection experienced exceptional fatigue, relief from fatigue by Sunday morning. The following two days after injection experienced redness around injection site.
Noo additional adverse effects reports; one male patient was administered improperly stored ROTATEQ; This spontaneous report was received from a vaccine coordinator and refers to a 4 month old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-MAR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # 1658255, expiration date 07-FEB-2021 (dose and frequency were not provided) for prophylaxis. No additional adverse effects reported. Administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion below 2 Celsius degrees (C): 0.8 C for 5 hours and 9 minutes on 02-MAR-2020; 0.9 C for 11 hours on 04-MAR-2020 and -1.3 C for 9 hours and 29 minutes on 05-MAR-2020. There was previous temperature excursions reported. The administered doses of the suspect vaccine experienced the temperature excursion above 9 C: 9.3 C for 3 hours and 33 minutes on 25-FEB-2020 and below 2 C: 0.8 C for 11 hours 39 minutes on 03-MAR-2020. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. The outcome of the events was unknown.
1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient felt numbness of lips -- > sent to ER
covid vax 2 given 2/16/21, and #3 ? mfg or lot # given 8/21/21  Sudden onset shortness of breath, called EMS, D-dimer was noted to be elevated at 32,072 on 15 June 2021 and a VQ scan showed high risk for bilateral pulmonary emboli, he was started on a heparin drip and transitioned to Eliquis, aspirin was continued that he was on prior to admission, and symptoms of shortness of breath continue to improve on anticoagulation  He has not had Covid but has had his Covid vaccines completed 16 February 2021, CBC normal, creatinine 1.37, GFR greater than 60, no travel or hormone use or recent surgeries though he is immobile on a regular basis, weight is just over 120 kg  December 2021 will transition to Eliquis 2.5 mg twice daily plus baby aspirin