chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely painful arm that prevented me from being able to use my arm; not ?sore? arm, but very, very painful arm. (Arm pain started approximately 3-4 hours after vaccine). Following symptoms started approximately 19 hours after vaccine:   Body full of pain mostly in arms, neck, low back, and legs.  Not achy, but pain.  All over pain with shooting pain in legs.  Fever went as high as 101.8 F.    Freezing with lots of shivering/shaking despite multiple layers of clothes and blankets.  Fatigue, but unable to sleep due to amount of pain.  Next day only symptom was excruciating headache that lasted approximately 12 hours...took Tylenol and Ibuprofen.
I have had a persistent right sided headache after receiving the Pfizer Covid-19 vaccine. The pain is constant and never goes away.; It has become debilitating.; This headache is causing me to be dizzy; This headache is causing me to be dizzy and nauseated.; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 28Feb2022 (Lot number: unknown) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. Past drug history included: Stadol, reaction: "Drug allergy", notes: Known allergies: Stadol.  The following information was reported: HEADACHE (non-serious) with onset 01Mar2022, outcome "not recovered", described as "I have had a persistent right sided headache after receiving the Pfizer Covid-19 vaccine. The pain is constant and never goes away"; ASTHENIA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "It has become debilitating"; DIZZINESS (non-serious) with onset 01Mar2022, outcome "not recovered", described as "This headache is causing me to be dizzy"; NAUSEA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "This headache is causing me to be dizzy and nauseated". The events "I have had a persistent right sided headache after receiving the Pfizer Covid-19 vaccine. The pain is constant and never goes away.", "It has become debilitating.", "This headache is causing me to be dizzy" and "This headache is causing me to be dizzy and nauseated." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, asthenia, dizziness and nausea.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that the patient had to see a neurologist to get those headaches managed because OTC Motrin, Tylenol, and Excedrin did not help ease the headaches. She had to have a computerized tomography (CT) scan of head/brain to rule out Cerebral venous thrombosis (CVT) and would be having a Magnetic resonance imaging (MRI). The patient never had headaches like those before the vaccine. The patient would have had an occasional headache from time to time that was resolved with over-the-counter (OTC) medication. She had never been diagnosed with migraines. Treatment included Fioricet and Tizanidine for headache, asthenia, dizziness and nausea. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT REPORTED RED, ITCHY BLOTCHES COVERING A SIGNIFICANT PORTION OF HIS BODY. HE STATED THAT IT BEGAN THE DAY AFTER THE VACCINE AND IS STILL OCCURRING TWO WEEKS LATER. HE HAS VISITED THE EMERGENCY DEPARTMENT AND A DERMATOLOGIST AND REPORTS THAT BOTH HAVE ADVISED HIM THAT THEY BELIEVE IT IS STEVENS-JOHNSON SYNDROME.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-OCT-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-FEB-2015 the patient was treated by a physician at his medical practice for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
No additional AE reported; HCP called to ask how long she needs to wait between administering of MMR II and VARIVAX? HCP continued to say that the patient was 8 years old received MMR II (3rd or 4th dose) yesterday 5/25/2023. She did not have his full records since he has move; This spontaneous report was received from Consumer and refers to an 8-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-MAY-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 25-MAY-2023, HCP called to ask how long she needs to wait between administering of MMR II and VARIVAX? HCP continued to say that the patient was 8 years old received MMR II (3rd or 4th dose) (Extra dose administered). She did not have his full records since he has move. She informed that he needs to receive VARIVAX to attend school. HCP did not have the time to stay on the line to report the AE. HCP did give permission to contact her for additional information. HCP did not wait to get her case#. HCP was in a rush and had to get off the phone. On an unknown date, the patient experienced No additional AE reported.
C/O pain (L) shoulder and (L) neck pain started 10/10 in evening. States twitching pain with movement - on 10/15/18. States that pain improved but not completely resolved. Also C/O feeling "off balance". Which is better but not completely resolved.
Client reported chest pressure to EMT at approximately 6:40 PM. Client ambulated unassisted, sat down in the anti-gravity chair, and the chair was reclined in a semi-fowler's position by EMT. RN responded. The client reported chest pressure, shortness of breath, and feeling hot on her chest. Client denied any itchiness or feeling of swelling on her throat, lips, or tongue. EMS was activated at 6:41 PM. Client denied any history of chronic conditions or medications. Client reported a history of "bleeding inside" after taking NSAIDS. Client was alert and oriented to person, place, time, and situation. RN did not see any visible swelling of the lips or tongue. Vitals obtained at 6:44PM were as follows: manual BP 150/80, HR 106, O2 98%. Repeat automatic BP reading was 173/101. Client reported a history of hypotension. RN noted visible hives on the client's chest and recommended administration of IM Benadryl. The client reported difficulty swallowing to RN. Client stated she had previously taken Benadryl without any adverse reactions. The client provided verbal consent and RN administered 1 mL (50 mg)  of Benadryl intramuscular into the right deltoid at 6:48PM. Client reported persistent chest pressure and difficulty breathing. RN did not note any signs of swelling on the client's lips or tongue. The client was alert and oriented to person and place and verbally responsive to questions. EMS arrived on site and assumed care at 6:50PM. Client was transported by
Nauseous; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nauseous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient has not taken any medication for treatment, but plans to take something for the nausea.
Arm pain that lasted 2.5 months according to pt.  The pain completely resolved after 2.5 months
Swelling under arm and lymph nodes. Went to Dr who sent me for  mammogram and ultra sound. Went back after 3 months for 2nd ultrasound. Still had swelling and now going next week for another follow-up ultrasound.  Mammogram was normal.
Patient is 30.3 weeks pregnant. Received vaccine in LD IM. Called on 7-25-18 at 8:54 to report that left arm feels heavy and sore, had temp = 103 and chills. Feels achy all over. No meds taken. FNP recommended EXTRA STRENGTH TYLENOL as directed. Patient to call if no relief. Will check with patient 7-26-18 if no response from patient. To call HD or go to ER if worsens. Had MVA on 5-12-18.
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 09-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2003USA007542: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
After vaccination that evening I started vomiting, the fatigue started the next day and it was mild. Day 6 or 7 in the middle of the night I had an itchy arm that woke me up,went back to sleep, woke up the next moring my arm was blown up like a balloon and I was worried about cellulitis, but this lasted about 4-5 days and I was back to normal.
Pt recvd vax 11JUL92 following vax devel idiopathic thrombocytopenic purpura; subsequently hospitalized & needed spleen removed;
7 days after the injection,  on 12/31 morning,  hives appeared 10cm below the injection site to left arm. Progressively, left arm became red, warm to touch, hard, swollen, itchy and painful through the course of the day. It spread rapidly and pain was radiating under left breast, where the lymph nodes are located, behind back/shoulder. The following  day it has spread even further,  down to elbow; numbing/tingling sensation radiating to left pinkie and left ring fingers.   Vital signs: higher than normal systolic BP 130-150s (normal for me:100-110s); tachycardic with HR in 130-140s on the first day of the adverse event, O2 sats normal high 90s to 100% on RA. No fever, highest temp 99.2F.
Within a short time after injection, developed a cough, sore throat, felt feverish but did not take temperature, had a headache. Left work to go home to rest. Discomfort off and on until went to bed for night, slept well. Went to work next day just feeling tired but all other symptoms gone. Has had vaccine past 7 years without any problem.
Received vaccine on 12/30/20 approx. 5pm. On morning of 12/31/20 experiencing fatigue, chills, aches, fever, loss of appetite and diarrhea. As of 1/4/21 continues to have diarrhea and loss of appetite. Going to see provider today as she found out that a church member tested positive for covid. planning to be tested today.
Dry throat; Numbness in left hand stiff at times; Numbness in left hand stiff at times; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 07Apr2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication from unknown date for blood pressure and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 14:00, the patient experienced dry throat, and numbness in her left hand stiff at times. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dry throat, and numbness in left hand stiff at times was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received first dose of MODERNA COVID vaccination on 3/8/21.  On 3/9/21 she developed chills, headache, dry heaves, and fatigue.  This last 24 hours and resolved with rest.
Chest pains and violent pflemy cough, tachycardia, high blood pressure.
1 month following 2nd injection, the pt became hot, dizzy with impaired vision. This reoccurred 1 week later and was worse. A CAT scan was performed. The pt remained sun sensitive all summer and was never sensitive before. The pt recovered during the winter months. Problems reoccurred in late Feb in the left great toe. The pt saw a podiatrist, had biopsy. Pain in toe (foot and thigh) lasted 4 months. Problems increased in 7/01 with multiple joint pain and heat sensitivity. Saw MD several times. The pt was treated with 400 mg of Celebrex daily. The pt has an appointment with rheumatologist. Additional information received on 12/26/2001: Patient continues to have symptoms as previously stated. He is being seen by a family doctor and Rheumatologist. After extensive blood tests, they are 99% sure that patient has some type of Lupus, but no definate diagnosis. We feel this was caused by the vaccine. He had no medical problems prior to the injections. Follow up information received 10/18/02 stated, " Pt diagnosed with Lupus. Pt still has some of the same original symptoms and is under doctor's care. He will have to be on medication the remainder of his life."
Fever to 104.4 (max) and suspected seizure x 30 secs. Paramedics called. F/U appt. next day.
pt was given Menveo in office. Pt waited the 15 minutes. Stated she was fine and left with her mother.  When pt was walking to their car, pt became faint and passed out. Rapid response was called. ER provider, 3 RNs, 2 ER Techs, Respiratory therapist came to pt within 3-5 minutes. Pt was evaluated by the ER provider and was determined that d/t pt had not eaten since the afternoon of the day before she had a vasal Vagle occurrence.  Pt was given juice, banana, and a candy bar.  Pt was doing better after 20-30 minutes and allowed to go home with her mother. Mother did refuse to go to ER with daughter. Reminded to return to ER if s/s returned. Mother voiced understanding.
improperly stored PROQUAD that was administered; Information has been received from a nurse, referring to a currently 4 years old patient of unknown gender. Information about medical history, concurrent condition and concomitant therapy was unknown.   On an unknown date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T003833, expiration date: 01-AUG-2021, therapy type: recombinant Human albumin (rHA); dose, strength and route were unknown) for prophylaxis (product storage error). Temperature excursion was reported as range -14 Celsius degrees (C) to -10 C (-11.84 C) for time frame 40 minutes, range -9 Celsius degrees (C) to 8 C (-4.12 C) for time frame 30 minutes. There was no previous temperature excursion. A digital data logger was involved. No product quality complaint (PQC) was involved in the case.
On an unspecified date, the vaccinee received her 2nd dose of Engerix-B. Subsequently, she experienced a rash at the injection site. As of 4/23/02, the outcome of the event was unknown.
Within a week of receiving the Covid vaccine last year and for every month since, my menstrual cycle has been drastically changed. The color of my menses has been nearly black every time.  I 'spot' for nearly a week without any real breakthrough bleeding, and mostly just have extreme cramping without any thorough bleeding---just some dry, sparse, blackish menstrual blood. My menses has NEVER been this dark, irregular, or uneven in flow.
Lot expired on 9/30/22 but was administered on 10/6/22. Information received from manufacturer indicates that stability data supports the use of this product through 10/19/22.
loss of appetite; diarrhea; vomiting; on and off fever; vaccine administered that day was expired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (on and off fever) and EXPIRED PRODUCT ADMINISTERED (vaccine administered that day was expired) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered that day was expired). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), VOMITING (vomiting) and PYREXIA (on and off fever). At the time of the report, DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), VOMITING (vomiting), PYREXIA (on and off fever) and EXPIRED PRODUCT ADMINISTERED (vaccine administered that day was expired) outcome was unknown.            Concomitant drugs were not reported. It was reported that patient received expired vaccine but since it was given within the grace period of 30 days it was okay. Patient visited twice to urgent care. Treatment medications were not provided.
Reported dairy/egg allergy but egg was not anaphylactic. After agreeing to vaccine, received it, then reported GI issues. Then itching systemically with some redness (not hives but redness), diaphoretic and then reported tongue swelling. Was taken to UC and checked in. In same bldg as work place where employee flu vaccines being given. She took 1 benafryl pill in bathroom during GI issues on her own without recommendation. Received more at UC and then epi pen.
Patient developed headache after receiving GARDASIL 9 immun. Headache developed within 15 minutes after immunization. Patient was brought back into exam room and examined. Neuro intact. Was given TYLENOL and food. Headache.
Patient received the vaccine after the BUD; vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) 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 (Patient received the vaccine after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. Dates of administration of vaccine was reported as 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023 and  21-Feb-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 9th of 42th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Patient 1 (Master Case)
It started as a scratchy sore throat. Then congestion that seemed to be only in my throat. My sinuses were not draining. I thought I had a strep throat and I did a telehealth visit with my doctor. He ordered a strep test and a Covid test and both came back negative. Things started to settle down. They gave me Prednisone and antihistamine. Within a few days I was feeling fine.