chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak.  Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the unspecified number of patients were vaccinated with improperly stored oral, ROTATEQ (lot# K016263, expiry date: 14-JUL-2015, lot# K016261, expiry date: 15-JUN-2015 and lot# K023532, expiry date; 19-MAY-2015) prior to the labeled expiration. No adverse effects were reported. Additional information has been requested.
Patient feels very sored muscle and it hurts when she raise her hand. She's been using hot compressions and VOLTAREN gel. Her Dr. said nothing serious and should go away.
Expired dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No treatment medications was provided.
Day 1.  Evening, sore upper left arm. Day 2.  Cold and achy all day;  not chills, but rather cold from the core on out.  Stayed in bed bundled up with lots of covers, no sleep all day.  Got up every two hours to pee and eat something.  In a.m. could only navigate going downstairs by one step at a time with both feet and holding securely to rails on both sides, as I did not trust my knee, hip, ankle and feet joints and muscles.  By end of day could navigate stairs normally.  Fatigue, foggy mentally, and bicep pain and limited range of motion all day.  Night 2.  Woke at 3 a.m. with extreme headache; got up and went pee and drank a half cup of apple juice; headache gone in twenty minutes and went back to sleep. Day 3. Thigh and calf muscles of both legs, but mostly left thigh, spasm-ed with pain, off and on all day.  Body temp back to normal.  General achiness, fatigue,  lack of mental clarity, and pain itchiness redness of left bicep and limited range of motion continued. Day 4.  Nose bleed lasting about five minutes, mid-morning.  Achiness and fatigue not as severe; clarity returning. Days 5 through 7.  Gradual improvement of all symptoms. Days 8 through 14.  Final resolution of all symptoms;  able to confidently take dog for regular walk, and to do errands and important financial coversations.
After injection in arm, felt just local pain maybe 3 out of 10, then around 12 hours later, pain at injection site shot up to maybe 9/10, started to feel chills, aches, chills were really bad, couldn?t get warm so took hot bath, drank some tepid water and went to bed.  Chills gone in morning. Arm pain back to 3/10 except if I touched it, then up to 7/10.  Had local pain, and felt like there was a bump, itchy for 3 or 4 more days but no other symptoms.  Since its a fairly new vaccine, thought I should report it.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult 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 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case pertains to the 32nd patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
no adverse effect reported; the patient received improperly stored PROQUAD; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown) (product storage error), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a 4 years old female. On 27-NOV-2018, she was vaccinated with improperly stored varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012377:
The pt developed generalized red rash on trunk of body with small blisters. Pt has had rash for 6 days at the time of report. Treated with prednisone, Zantac, and Clarivex.
Patient received vaccine and later that night symptoms of swelling started. This is a new problem. The current episode started 3 to 5 days ago. The problem occurs constantly. The problem has been gradually worsening since onset. The problem is moderate. Associated with: received pneumonia immunization and symptom started on the night. The exposure occurred at home. Swelling location: present on the axillary area, left side. Past treatments include ibuprofen. The treatment provided mild relief.
Information has been received from a certified medical assistant (CMA) concerning a 17 year old female with no known drug allergies and asthma who on 31-JUL-2007 was vaccinated with the first dose of Gardasil. On 25-SEP-2007, the patient was vaccinated in the left deltoid with the second dose of Gardasil (lot # 658563/1063U). Concomitant therapy included ADVAIR and MAXAIR. On 27-SEP-2007, the patient experienced fever for 2 days and called the physician's office. No laboratory/diagnostic tests were performed. There was no illness reported at the time of vaccination. On 29-SEP-2007, the patient recovered from fever. Additional information has been requested.
nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: "polyethylene glycol". Outcome of nausea was not recovered. Outcome of other events was unknown.  Information about lot/batch number has been requested.
"Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern"; "Had a little headache"; This spontaneous case was reported by a patient and describes the occurrence of RASH ("Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern") and HEADACHE ("Had a little headache") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ZINC, MULTIVITAMIN [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ("Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern") and HEADACHE ("Had a little headache"). At the time of the report, RASH ("Rash localized on right inner thigh", Rash description: "Lacey, reticulated, localized vascular pattern") and HEADACHE ("Had a little headache") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment products reported.   This case was linked to MOD21-091683, MOD21-091684, MOD21-091689, US-MODERNATX, INC.-MOD-2021-143088 (E2B Linked Report). This case was linked to MOD-2021-142886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non-significant follow up received on 18 May 2021; Sender's Comments:  MOD21-091683:crosslinked MOD21-091684:crosslinked MOD21-091689:crosslinked US-MODERNATX, INC.-MOD-2021-143088:Crosslink
felt very dizzy, tightness of chest and stiffnes of neck, palpitations, cold extremities. constant urination and bowel movements during attack.
devel fever of 103 by 630PM 8OCT93; called MD & was seen 9OCT93; cold sx cough & h/a; MD stated it was caused by the flu shot; pt was given rx of Ceclor;
Patient should have received PNEUMOVAX 23 vaccine as he had been given PREVNAR 13 one year prior. Instead he was given PREVNAR 13 vaccine again.
I'm having fatigue, muscle soreness, shortness of breath, no change in smell or taste, I'm having a fever, and bad cough.
Tiredness, chills, headache, heart palpitations, feeling weak, shakiness, fever (100.9), and nausea
Information has been received from a registered nurse for the Pregnancy registry for Gardasil concerning a 26 year old female who on 20-DEC-2006 was vaccinated IM with the second 0.5 mL dose of Gardasil. The patient was vaccinated with the  first 0.5 mL dose Gardasil (lot # 653937/0637F) on 27-OCT-2006. Concomitant therapy included hormonal contraceptives (unspecified). In January 2007, the patient became pregnant. In March 2007, the patient had a miscarriage at 8 weeks gestation. The patient sought unspecified medical attention. Subsequently, the patient recovered. Upon internal review, the patient's miscarriage was considered to be an other important medical event. Additional information has been requested.
On April 26, 2010 this child broke out with a rash mostly all over the trunk of the body.  None on arms and face. There was no cough, cold, or conjunctivitis. Patient was seen by his PCP Dx. Viral infection.  Patient Started with fever on 04/29/2010 and was up to 104 F. Saw the PCP on 5/03/2010 and was hospitalized due to the high fever still getting up to 104 F.  Hospitalized x1 day.  Dx: Viral Infection.  Rubeola IgM ordered.
Pt awoke as usual to urinate.  She shivered without being cold and began to feel nauseous.  She yawned repeatedly, but slept very poorly.  At 8:30 AM, she experienced dry heaves, but did not vomit. However, her headach became worse.  At 11:30 AM she took ALEVE with good relief from the headache.  By 3:30 PM, she felt pretty much entirely well.  Pt evaluted her blood sugar.  At 2:30 am it was 89.  She consumed some orange juice at that time.  At 8:30 am it was 152.
Per public health department event is to be reported if patient gets COVID if fully vaccinated. This person was vaccinated on 2/3/21 and 2/26/21 for COVID-19. On 8/9/21 she presented to Hospital w/SOB and was diagnosed with COVID. Receiving palliative care prior to admit. Currently she is intubated in ICU.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness and bump, all at the injection site. The subject didn't use a heavy duty Band-Aid. At the time of reporting, the events were still unresolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
Pain on the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 91-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Nov-2022 Reporter's comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The reporter asked what he/she could give to the patient for relief of the pain on the site were she was given injection. Additional supportive information: Follow-up would not possible as no contact details were available.
On 3/7/21 I felt fine, the next day on 3/8, I was very active that day. That night I did not feel well, I felt flu symptoms. My body was achy and I was tired. I rested just thinking I overdid it, running my immune system down. The next day I felt find, I was walking 2-3 miles. I felt great and was active. Four days after my vaccine, I felt a little tired. I was starting to get arrhythmia. The following Saturday I started feeling a tingling in my left arm and left leg, I called the hospital. I drove myself to the hospital. My heart was beating fast, I was in the ER for 10 hours doing tests. They said  I did not have a stroke but there was elevation in my heart. They had me on IV. 10 hours later I was transferred down to another hospital and stayed overnight. My cardiologist came in the next morning and told me I had a heart attack. They transferred me again to another hospital and did an angioplasty. When I woke up from that and was told I had very little plaque in heart and everything looked good. I went home the next day. I was put on metoprolol and have to take a baby aspirin everyday.  I haven't had any palpitations since.
Approximately 3 minutes after receiving the vaccine, while waiting in the designated area for his 15 minutes, the patient started feeling lightheaded and experiencing vasovagal syncopal symptoms. I was grabbing a bottle of water for him when he fainted and fell out of the chair he was sitting in at the time.  I rushed to him and rolled him to his back. He had already regained consciousness in the 2-3 seconds it took to get to him. He was pale and clammy, but stated he was feeling much better. he asked to sit back in a chair, so I had him sit in one with arms. 9-1-1 was called and the rescue squad arrived. His blood pressure was 130/82 and his pulse was 73, his o2 sats were 98% and he was alert and oriented x 4. He declined going to the hospital with the rescue squad and his girlfriend who was with him drove him home after another 20 minute wait.
Irregular menstrual bleeding.  Period at 7 weeks postpartum while exclusively breastfeeding.
Sharp Pain in shoulder blade and Rib Area under Arm Pit on the same side as vaccine was injected. Pain is worse with movement and deep breaths as diaphragm expands.
12AUG devel temp of 102.5 early AM; vomited afternoon temp went down; 13AUG & 14AUG listless, no temp, no rash; 15AUG93 devl very red pen point size rash on cheeks, around mouth, arms & upper trunk; temp 99.3 17AUG93, sl red rash;
2 days after the vaccine, patient developed swelling of left arm from shoulder down to forearm, with increased warmth, and redness. No fever, minimal pain. Patient seen in office after this developed, and swelling has already started to decrease.
L arm SQ area red and swollen about half of back arm, hot to touch, hurts to touch and itching.
Developed shingles on left hand near palm one week after second dose of Moderna vaccine.  Sharp pain (like a pinched nerve) in left shoulder, neck and hip.  Blisters partially scabbed by the time treatment was sought at urgent care center a week later.  No treatment provided but self-diagnosis confirmed.
Per mom, pt had shots hadn't ate a lot today. When left office, didn't feel well, sat on steps outside office. Still wasn't feeling well. Went to car, then he got "stiff, eyes rolled back, and jerking for a few seconds" Mom brought pt back in office.
edema & pain started day p/vax;edema lasted 7 days, pain cont;pain starts @ inj site & goes to elbow;has severe pain when reaching out in front of body, behind body & can only reach 3/4 way above head;can not pick up objects 5lbs or more;
sw pt wife reporting on 10/15/2021 @2am after covid 19 pfizer vaccine administered on 10/14/2021 pt went to er  with chief complaint of headache, increase blood pressure(systolic 220) at urgent care, & fever of 104F. Urgent care gave fluids and recommended going to ER where pt was admitted to hospital for 4 days stay.  Doctors ruled myocarditis diagnosis due to Pfizer Covid vaccine.
BODY HURTING; LEGS DID NOT SUPPORT; FEELING TIRED; PAIN IN RIGHT SIDE CHEST; PROBLEM BREATHING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and diabetes, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced problem breathing. On 10-APR-2021, the subject experienced pain in right side chest. On 17-APR-2021, the subject experienced body hurting. On 17-APR-2021, the subject experienced legs did not support. On 17-APR-2021, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, body hurting, problem breathing, legs did not support, and pain in right side chest. This report was non-serious.
Pt reported numbness/ tingling in right arm, disorientation, after flu vaccine. Pt also reported itching on back and right leg and warmth and itching in face. HR increased to 120bpm @ approx 12:04pm. Pt did not experience any SOB/ wheezing or resp distress. Pt was administered 25mg diphenhydramine in clinic at approx 12:10pm. Pt laid supine on exam table for approx 10 mins. Hives on right forearm began to develop at 12:14pm and itching began to worsen on right arm, face itching increased as well during this time. EMS activated at 12;20pm. Hives developed on forehead at this time as well.