chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/10/21 (el3302) Pfizer Dose 2 3/4/21 (EN6199) Pfizer Dose 3 10/20/21 (lot not listed in database) COVID Positive 10/24/21  10/24/21: Patient is an 80-year-old male who presents to the ED today after being seen at Facility for shortness of breath. The patient has a past medical history significant for asthma, type 2 diabetes, OSA, HLD, HTN. The patient tested positive for COVID-19 today while at Facility, at which time patient pulse ox was low on room air.  The patient was encouraged to proceed to the emergency department for further evaluation.  The patient is vaccinated against COVID-19 and received his booster vaccination on Wednesday. He denies any fever, chills, body aches, chest pain, nausea, vomiting or diarrhea. His accompanying symptoms include headache, SOB and a productive cough.  Patient was seen and examined at the bedside in the ED.  the patient states he feels much improved since arrival and his shortness of breath is improved.   Upon arrival to ED patient's temperature is 99.3°, heart rate 105, respirations 26, pulse ox 86% on room air, blood pressure 215/92.  The patient was placed on 3 L oxygen via nasal cannula to maintain O2 saturations greater than 90%. Patient's chest x-ray revealed no acute cardiopulmonary process.  CTA chest completed which revealed no PE. Patient's laboratory findings are significant for glucose 234. The patient received 10 mg p.o. amlodipine, 30 mg IV Toradol, 2.7 L IV LR, 750 mg IV Levaquin.  10/27/21: Discharge Plan: P.o. azithromycin course  P.o. Decadron  P.o. zinc sulfate and vitamin-C  COVID-19 precautions per CDC guidelines  Hemodynamically stable for discharge  Will discharge home  Follow-up with PCP in 3-5 days  Patient agrees with plan of care
immediately after dose arm was sore as expected. This subsided within several days. No additional issues were noted until day 13 post dose when I suddenly felt an onset of a raised, warm, reddened area that was very sore and achy. Being a nurse I recognized this as cellulitis. I managed on my own as it was the weekend and I could only go to an ER which seemed unnecessary or the urgent care, which I knew would be busy. It subsided within two or three days
This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications. On 11-NOV-2021, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB), pre-filled syringe, 1 dose, lot #S002769 for prophylaxis (route and site of administration were not reported), which had expired on 04-NOV-2021 (expired product administered). The reporter confirmed no other adverse event occurred (no adverse event).
Severe insomnia, severe back and knee pain, extremely lethargic and fatigue  to a point cannot function normally
Pt developed severe respiratory distress within 30 mins. He is known to have bronchospasm in the past but no recent events. Pt received Benadryl, Orapred and Xopenex in office with resolution. Also hives.
Within 5-6 hours I developed a fever 101.2 body aches nausea and runny nose. I then took 200mg of ibuprofen. Later I developed diarrhea 5-6 watery stools. Later approx 0130 I developed a 103.5 fever. Took 400mg ibuprofen with little results. Sore L arm. Body aches.
Itching, hives, and swelling after Hepatitis B shot on 5/29/2021
Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 08-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011133: US-009507513-1610USA011245.
muscle pain; joint pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 031M20A and 025A21A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Allergy to Hydrocodone) and Allergy to antibiotic (Allergy to Ciprofloxacin). Concomitant products included ATORVASTATIN, METFORMIN, METOPROLOL, SERTRALINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (Fever). On 26-Nov-2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (Fever) had resolved.            On 19-NOV-2021 the patient received 1st booster dose. After receiving dose, the patient experienced muscle pain, joint pain, and fever. The patients symptoms lasted for a week, after which felt better.  The patient was never tested positive or diagnosed with COVID. The patient not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No treatment drug details was reported.   This case was linked to MOD-2022-595147 (Patient Link).
BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Non-smoker and Abstains from alcohol. Previously administered products included for an unreported indication: METHOTREXATE (for rheumatoid arthritis).   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced RASH (BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE). At the time of the report, RASH (BROKE OUT IN NECK AREA,ARM,LOWER BACK WITH RASH/ITCH AFTER GOT THE COVID VACCINE) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
First vaccine around 3:30PM on 4/14/2021. Sore arm started 7PM. 9:30AM started feeling unwell; body aches and pains, chills, a bit of a headache. 11AM very fatigued. No appetite. Fever confirmed 4PM.  Next day 4/15/2021, felt unwell as though I was getting sick or getting over being sick. Symptom free on 4/16/2021.
Pt recvd 3 doses of Engerix-B 6MAY91, 3JUN91 & 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
"somewhat extensive" blood clots in left calf and thigh. Symptoms originally noticed June 19th. Patient thought it was pain from exercise. Progressively got worse. Patient was diagnosed on July 28th.
Couple hours after receiving the shot I felt Fluid in my lungs end it has not subsided yet
Knee (Right) arthritis; Right Knee swelling; Pain at injection site (left); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Knee (Right) arthritis), JOINT SWELLING (Right Knee swelling) and VACCINATION SITE PAIN (Pain at injection site (left)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Chronic kidney disease.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Knee (Right) arthritis), JOINT SWELLING (Right Knee swelling) and VACCINATION SITE PAIN (Pain at injection site (left)). At the time of the report, ARTHRITIS (Knee (Right) arthritis), JOINT SWELLING (Right Knee swelling) and VACCINATION SITE PAIN (Pain at injection site (left)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Mar-2021 the patient received treatment for the right knee arthritis which included a steroid injection in the right knee. Euflexxa was additionally reported as treatment though based on the report it is unclear if the patient received this treatment ("date TBD").   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-May-2021 included no new information.
metallic taste in my mouth for 3 days, fatigue, upset stomach--felt like heartburn but wasn't
Information has been received from a physician concerning a 21 year old female who on 21-JUN-2007 was vaccinated with a second dose of Gardasil (lot # 657737/0522U). On 22-JUN-2007 the patient experienced nausea and diarrhea. Unspecified medical attention was sought. On 25-JUN-2007, the patient recovered from nausea and diarrhea. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional information has been requested. Initial and follow-up information has been received from a physician concerning a 21 year old female student with an allergy to NUVARING (localized swelling) who on an unspecified the patient was vaccinated with a first dose of GARDASIL. The physician reported that the patient had no adverse event in prior vaccinations. On 21-JUN-2007 at 11:11 am, the patient was vaccinated IM in the right deltoid with a second dose of GARDASIL (lot # 657737/0522U). Concomitant therapy included LOESTRIN, and ORTHO-NOVUM. On 23-JUN-2007 the patient experienced nausea, diarrhea and stomach discomfort. On 26-JUN-2007, the patient recovered. It was reported that the physician suggested to the patient that she can receive the third dose of the vaccine. Additional information is not expected.
Wishing 10 mins of receiving vaccine, I stated having muscle spasms in my right chest and right side of face. Also experienced fatigue and dizziness throughout the day, easily tired with moderate activity. Mild to moderate pain and muscle soreness in that right arm. Elevated blood pressure that night. Lightheadedness and dizziness  the next morning when I first got out of bed. Also had a persistent, mild headache that day. I felt my usual self 3 days after the vaccine.
Numbness in mouth, lips teeth, Redness in face, itching on face and head, rash across arms and chest. Joint pain, fatigue. Took Benadryl went to bed.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L0140421, expiration date: 15-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 20 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Report fever (102.2), body aches and left arm soreness.  Treatment: None.  Outcome: Fever resolved (99.3), left arm soreness and body aches remains unchanged. Does not interfere with ADLs.
Information has been received on 01-FEB-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 18-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2014, a few weeks after being vaccinated, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 17-APR-2014, the patient received subsequent treatment for new and ongoing symptoms of shingles and pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage caused secondary to zoster infections. On or about 11-FEB-2016, the patient was treated for continued and worsening pain, which was identified as neuralgia that was not able to be adequately controlled by treatment. The patient has been prescribed gabapentin, tea, LIPODERM and LORTAB for management of her persistent symptoms and chronic pain. 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. Additional information has been requested.
Vaccine given 9-25-12. On 10-16-12 pt. reported painful shoulder, possibly in joint for 3 weeks after injection. Pain is waking her up at night. She is thinking about going to the Dr. in a few days if it does not improve.
I started with body aches, head ache, chills then my fever got really high, vertigo, the worst headache I ever had in my life and my body pain was really bad I could get out of bed that night and the next day and it was 3 days before I was up and moving again
Patient was given Pneumo vaccine left arm 12/3/02. Patient called clinic 12/4/02 next day stating "left arm red with rash and hurt a lot." Patient was told to apply ice pack, take Tylenol. If not better RTC.
congestion like head cold  started on 1-4-22 . Low grade fever and abdominall discomfort on 1-5-22. Told to isolate at home since vaccinated x2  and boosted. O2 stats ok. On morning of 1-6-22 found unconscious at home by my son. Was able to be aroused and coherent. Taken to Hospital ER. In acute distress with STAT echocardiogram showing massively dilated left heart and ejection fraction 10% Admitted with acute covid myocarditis and cardiogenic shock. To cardiac ICU intubated and placement left ventricular assist device. Transferred to another Hospital for advanced heart failure team in that ICU. Multisystem organ failure. 9 weeks of ICU care no renal function, could not speak or swallow, covid coagulopathy,, lower GI bleed and other complication. Finally taken off life support. Expired 3-3-22.
Immediately after vaccine administration, patient experienced chest tightness and sensation or throat swelling. Within 5 minutes, she had moderate arm pain with sensation of cold going down the arms. She had fever and chills that night. The next morning, her arm was swollen. She continued with fatigue and body aches until 2/1/21. She developed sore throat, and swollen lymph nodes on 2/4/21. On 2/8/21 She felt like she had a sinus infection with drainage and pain. 2/10/21 -2/14/21 she had fluctuating temp up to 100F.
Redness, swelling & itching at injection site. 10 cm; warm to the touch.
A report was received from a healthcare professional on 3 November 2003 concerning two vaccinees of unspecified demography who experienced fatigue, achiness and headache the day after receiving Influenza vaccine (brand unspecified) on an unspecified date. On an unspecified date two vaccinees experienced fatigue, achiness and headache.  Both vaccinees had received influenza vaccine in previous years without any side effects.  The outcome of the events were not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient was administered Moderna Booster. Approximately 5 minutes after receiving the vaccine, she c/o tingling in the left fingers which progressed up to elbow, followed by left sided facial numbness and tingling around her mouth, dizziness, and then c/o muscle cramping in left leg. Patient began visibly trembling.  She remained alert & oriented and denied N, V, CP, or respiratory distress. Epi Pen 0.3 mg was administered in left leg and EMS called. Patient was transported to Hospital for further evaluation. Her BP immediately after vax admin. was 120/70 and increased to 130's/80-90's (x2), Pulse ox 99-100% on room air. She did become slightly tachycardic following administration of epinephrine.  PMH: Patient reported that following 2nd dose of Moderna she experienced left hand numbness for one hour which resolved spontaneously.
Initially redness, soreness at injection site - approx 8 hrs later increase HR with some PVC'S, severe HA and backache, low grade fever 99.6 lt headed, body aches - (L) arm redness extending injection site to elbow -10/15/08 - Dx = Severe systemic Rxn to flu vaccine per ID physician told never have another flu vaccine.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Malaise Narrative:
Chills began 10 hours after vaccine and lasted from 11:00 pm-9:00 am.  Brain Fog most of next day after vaccine. Terrible headache  and nausea began 24 hours after vaccine and lasted approximately 6 hours.  3 Tylenol helped.  Inflammation at injection site lasting 2 days.
Patient received the vaccination in the right deltoid in the AM. Patient reported itchy red raised patches began to appear around the injection site in the evening. During the next 10 days, the rash spread to her back, neck, scalp, buttock region, and both arms, legs and feet. Patient has been self treating with oral Benadryl and topical hydrocortisone.
Information has been received form a 67 year old female with sulfonamide allergy who on 29-MAR-2007 was vaccinated with a single dose of zoster vaccine (Oka/Merck). On 30-MAR-2007 the patient experienced injection site rash. No medical attention was sought. No diagnostic tests were performed. At the time of this report the patient was recovering from injection site rash. No product quality complaint was involved. Additional information has been requested.
Attended vaccine clinic with friend.  After receiving vaccine and moving to observation area, pt reports noticing "her lips feeling normal but the tip of her tongue feeling tingly".  No other s/s of reaction noted after reviewing s/s of reaction with pt.  VSS BP 126/68,  HR 74. Resp 16.  Facial expressions symmetric, grips strength equal, arm strength equal, leg strength equal.  Water provided to pt.  2:44p Pt reports lips feeling normal but tip of tongue still feels tingly but I am fine".  Pt t remain in observation area and is not  interested in going to the ER as "I am feeling better".  3:01p S/S resolved, tongue is no longer tingly. Reviewed s/s of reactions vs side effects.  Agrees to notify PCP of response after vaccine and also agrees to call 911 with any s/s reaction upon leaving Hospital.
hives at site of injection, appeared 8 days after injection - no treatment at this time per patient request
This spontaneous report as received from a pharmacy technician refers to a patient of unknown demographics. The patient's pertinent medical history was not reported. On an unknown date in JULY-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (unknown strength and doe) and now like to receive her second dose. No adverse symptoms were reported. The outcome of the event was unknown. Additional information has been requested.
Swollen lymph nodes; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Lymphoma, Nodular lymphoma involving lymph nodes of axilla and upper limb and Chronic lymphocytic leukaemia.    No Medical History information was reported.   On 10-Jul-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Vial expired on 11/4/2021.  Notified Pharmacist, no recommendations at this time.  No adverse reactions noted from patient.
Pain in legs and feet (continues)  Extreme fatigue (continues)  Gastric distress (subsided)
5 days after injection, I started feeling extremely weak, followed by fever. My ability to taste and smell disappeared, then my tongue turned white, and then all the skin peeled off of it. I continued to have a fever of 101* for a week, followed by throat and ear pain. My stomach was upset, and I could only eat soup. I had diarrhea. I saw a doctor on April 3, and the Strept test was negative. They also administered a COVID test which was negative as well. I was given Prednisone and amoxicillin because I had a sinus infection.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 01-MAY-2014 the patients received a dose of VARIVAX (Merck) (Lot #, 0.5ml dose and subcutaneous route) that were improperly stored. Concomitant medications were not reported. All doses were administered according to the prescribing information. No adverse event reported. This case is linked to MARRS 1405USA002081. Additional information has been requested.
I didn't feel anything right after vaccine except I had tiredness for three or four days. I had a sore throat in June. I had the sore throat for three to five days and it was mild. No treatment.
6 PM 11/16/17: rigors chills, trouble sleeping, body weak feeling nauseous, swollen eyelids and redness this morning, feeling slightly better but still tired. Recommend BENADRYL 12 mg rest.
2-3 hours after 3rd rabies vaccination driving home felt disoriented/ mildly nauseated/able to drive home, no focal neurological signs , slept x 1 hour, felt better after nap.
Swollen lymph nodes, Fatique, Severe body aches for 3 days
Information has been received from a medical assistant concerning a pt who was vaccinated on an unspecified date with a dose of MMR II. Laboratory evaluation revealed a titer test indicated that the pt was not immune or protected from the measles. Unspecified medical attention was sought. Additional info has been requested.