chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irritation at site started evening of 3/11 & progressively worsened over next 4 days with line of redness from shoulder to elbow. Reddened area is swollen & hot to touch.
Flu vaccine was ordered for this patient who was 4 months old and the fluzone vaccine is for patients who are 6 months of age and older. There are no specific adverse events that were noted - needed guidance on next steps
Pt called pharmacy on 6/8/21 at approximately 10am and reported have chest tightness, and shortness of breath for the past 10 hours. Pt denies having any changes to medications or other conditions. Instructed pt to contact her doctor, or (if symptoms become severe), 911.
Persistent night sweats disrupting sleep; Persistent night sweats disrupting sleep; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 26Feb2021 10:30 (Lot number: EN6203) at the age of 64 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "overweight" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "known allergies: mice and rats" (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; VIVELLE DOT; GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]. Past drug history included: KEFLEX, reaction: "known allergies: Keflex". The following information was reported: NIGHT SWEATS (non-serious), SLEEP DISORDER (non-serious) all with onset 28Feb2021 23:00, outcome "recovered" (01Mar2021 01:00) and all described as "persistent night sweats disrupting sleep". Therapeutic measures were not taken as a result of night sweats, sleep disorder.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician and refers to an adult patient of unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with his second dose of a pediatric VAQTA 25/0.5 DF injection, 0.5 ml once, intramuscularly, lot # R00620, expiration date of 16-MAR-2019, for prophylaxis. The first dose was an adult dose and it was administered at an unspecified date. No adverse effects reported.
Narrative:  COVID infection following COVID vaccine series 01/14, Pfizer, dose #1 02/04, Pfizer, dose #2 08/02 pt cc: chills, cough, fever, headache, rhinorrhea, sore throat exposure: unknown 08/03 COVID swab, result: detected 08/17 clinically resolved
Pain in left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: Pain in left arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt date: 09-OCT-2023 The member of public received a dose of Arexvy and called in to request medical information stating she developed pain in left arm that had not receded. They were transferred to the correct department. The reporter denied the consent to follow up.
pt c/o h/a late on 18NOV97, took a dose of generic h/a med & went to bed;awakened @ 1PM w/hives over back, stomach;neck & arms w/intense itching, swelling of lips & tightness in chest;
After second anthrax shot, the pt's whole arm itched. The arm turned red around injection site and in the inside of arm where elbow bends.
Just after getting the vaccine had a sore shoulder for 2 days, then after that nothing until 8 days after getting the vaccine.  On the 26th, started feeling slight soreness in joints in muscles kind of like they were locked up, didnt think much of it, thought it was maybe from overdoing a gym workout.  The next day on the 27th, woke up and was feeling chills, along with mostly full body soreness and feeling very lethargic.  I also had a baseball sized red area on the injection site on my shoulder, it was itchy, swollen and felt very firm to the touch especially compared to other shoulder.  I also had hive like red circular welts on my back, butt, and upper legs.  Two of my fingers had spots on them that felt like blisters.  Felt very sore and tired all day.  In the evening I took 50mg benadryl to try and combat the symptoms.  When I woke up the next morning (28th) still had all the same symptoms just felt slightly better overall.  Took 50mg more benadryl and felt pretty tired and lethargic throughout the day.  In the late afternoon I have started feeling more sore again, and have a slight headache.  The hives and red area on my shoulder are still present but not as red.  So far during this time I have not had any issues with my throat and breathing, but my sternum has been super sore, more sore than any other part of my body during this time.  If i take as much air in as I can, it feels sore and hurts as I get to the last 10% of my lung capacity inhaling.
Office manager reports that nurse administered an expired VAQTA; This spontaneous report was received from a officer manager referring to a 12-month-old patient on unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not reported.  On 28-APR-2020, the patient was vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) by intramuscular route as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location of vaccination were not reported; lot number S002505 and expiration date 04-APR-2020) (expired product administered).
This is a serious literature-spontaneous case. This case was initially received on 14-Jun-2017, which was reported by other health professional, concerning a 67-year-old male elderly patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, batch number, expiry date, route of administration: not reported). It was reported that the patient had an abrupt onset left arm pain, 2 weeks following influenza vaccination. Approximately 1 month later, he developed left wrist drop accompanied by sensory loss. Neurologic exam revealed weakness predominantly in the left greater than right radial and median innervated muscles, right scapular winging, sensory loss in the left radial nerve distribution, and hyporeflexiain the upper extremities. Electrodiagnostic studies showed bilateral radial nerve palsy, left greater than right. A left superficial radial sensory nerve biopsy, done within a month of onset showed clear evidence of epineurial microvasculitis and axonal degeneration. He was treated with SOLU MEDROL and subsequently cyclophosphamide was added. At 6-month follow-up, he made remarkable recovery with complete resolution of pain and slow but definite improvement of strength. The outcome of the other events was not reported. The reporter did not provide the causality between the events and suspect product (INN Flu Vaccine Seasonal).
pt called to report a feeling of malaise some nausea & a reddened rash on forehead & lt side of cheek one day p/vax;denied fever-stated rash subsided following day;
Myalgia, Arthralgia, Fever, The employee reports that symptoms started 12 hours after the second dose of vaccine. Symptoms include: Fever up to 100.0 F, chills, body aches and muscle aches. Ibuprofen was effective. On 3 rd day continues with intermittent chills.. Narrative:
p/vax pt devel a varicella like rash w/an unspecified number of lesions on face & stomach & no fever;
Pain at injection site and in joints starting the evening of the injection.  The next day these symptoms continued and I also experienced headache, fatigue, chills and fever of 100.6 degrees. The following day (today) headache, fatigue and pain at injection site continue, but the other symptoms have subsided.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L037563, expiration date 29-SEP-2017; lot # K016127, expiration date 23-SEP-2016; dose and route not reported). The vaccine was improperly stored in 3.3 Celsius degree for 3 hours and 22 minutes. There were no previous exposures. Data logger was involved. No adverse effect were reported. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
feeling hungry; on off random aches and pains; 101 fever; vomited; got sick to my stomach; joint pain; Headache; elevated blood sugar; sharp arm pain; couldn't move his arm; shoulder pain; A spontaneous report was received from a consumer concerning a 32-year old, male patient who received Moderna's COVID-19 vaccine and experienced sharp arm pain, shoulder pain, inability to move arm, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever, joint pain, headache and random aches and pains.   The patient's medical history, as provided by the reporter, included Type-1 Diabetes.  No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient had sharp arm pain, shoulder pain and could not move his arm. He also reported a blood sugar reading of 417. After treating with insulin, it returned to normal. On an unknown date, the patient felt hungry around 4 am, with no relief by lunch time. On 02 Jan 2021, the patient got sick to his stomach and vomited. He also reported a temperature of 101 degrees Fahrenheit, joint pain, headache, and elevated blood sugar (390). Symptoms resolved that night. On 03 Jan 2021, the patient reports having a headache and on/off random aches and pains. Treatment for the event included an unspecified insulin.   Action taken with mRNA-1273 in response to the events was not reported.   The events sharp arm pain, shoulder pain, inability to move arm, headache, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever were considered recovered on 02 Jan 2021.  The outcome of headache and random aches and pains were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. These events could also be confounded by the type 2 diabetes history in the patient.
Weight gain-26 lbs (over 6 months) Head pressure-Heavy 9 months Lathargic Inability to focus Dissatisfaction with all food Poor digestion edema menstruation cycle inconsistancy Depression Mood swings  Have received chiropractic treatment.  Currently taking homeopathic treatment along with best foods to suppport reversal and recovery.
Patient was in observation. She stated she saw the room take a shift. She then got a headache in the back and on the top of her head. Her heart was also racing and she was dizzy.  We got the patient some juice and her lay down. Symptoms resolved other than headache. She reported it was still 5/10 when she left.
Red itchy  rash appearing on different areas of my body at random intervals,.  Leaves dark spots on my body.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: el5264), in left arm, on 28Feb2021 as dose 2, single (Lot number: en6200), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: fh8028), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 04Jul2022(ACC221) .  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (09Jul2022) Negative; (12Jul2022) Positive; (15Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other vaccines within 2 weeks and the patient had no known allergies.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20221003775 and 20221005834. This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be voided, this record states the patient was vaccinated and had covid-19. There is no product quality issue described in the information reported as there is no timeline for date of vaccination to contracting covid-19 and no confirmatory test reported, based on the evaluation/investigation performed.
Attending Physician:      Date of Admission: 1/31/2022     Source of Information: Patient and primarily chart review   History of Present Illness: The patient is a 95y.o. female who presents after being sent in from group home Apparently patient was diagnosed with COVID 5 days ago and there were some staffing issues at the group home the patient was sent to the hospital as a result Per information from the patient's son patient is fully vaccinated and has not really had many symptoms   The patient denies any true complaints at this time although the history is felt unreliable from the patient
FEVER OF 101 STATUS POST DAY ONE AS WELL AS CHILLS, MALAISE AND WEAKNESS,HEADACHE
patient fainted within 1 minute of getting vaccine. Came around very quickly, about 10 seconds. We got him to lay down, rest with legs on chair, felt better in 30 minutes with water and cookies. this is a known issue with patient and vaccinations
Headache, Chills, 101 fever, weakness, muscle aches, intense burning sensation in both arms, nausea,  shortness of breath  for 48 hours.  One incident of irregular pulse that lasted 45 minutes .
My first vaccine -(2021) I had side effect symptoms such as- headaches , fever,  muscle pains, nausea and diarrhea. Lasted  1 day- thereafter just had stomach issue with diarrhea. Second Dose of Vaccine-(2021- 3 weeks) the side effects and symptoms were worse- had all from headaches, high fever, chills, muscle aches, and vomiting's occurred with the second dose along with diarrhea.  Vomiting's lasted a few hours but the diarrhea was steady with stomach aches lasted about a week.   Booster Shot--(2022) Now this was by far the worse of the worse vaccines I 've ever experience in my life! Effects started about 10 hours after receiving the vaccine.  All symptoms from  headaches , high-fever- over 100--my face broke in heat rash --plus muscle pains, vomiting's- was 1-4 hours lasting heaving vomitted about 6-7 times within 1-4 hours the following day. Along with  with diarrhea on and off with in the 24- 48 hours- subsided but still has diarrhea for about 1-2 weeks.  Finally had shortness of breath with in the 24 hours period of having these HORRIBLE SIDE EFFECTS!!!!
No adverse event; Moderna dose administered to patient after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration).    It was reported that patient received second booster. Concomitant drugs were not reported. Treatment medications were not provided.
BODY ACHES, CHILLS, HANDS WEAK, TOP OF FEET HURT.
1-6-10 had 2nd set imms, return 2 days later with c/o rash begins on forehead, progresses to chin. 1-20-10 presents with "spots". Dr here, dx "mild varicella reaction", not related to rash on face.
A  few days after my 1st Pfizer vaccine my ear's started ringing, after my 2nd Pfizer vaccine 3.5 weeks later my ears started ring a little louder and as of today almost 4 weeks later my ears are still ring and I have developed a slight blood pressure.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test Negative (At night of Day 4), and HbA1C average 6.2 A1C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious.
Raised, red, itchy, rash at the injection site  extending out approximately 1.5-2 inches in each direction.
Painful, weakness to left shoulder and arm, warm at injection site, area firmer than surrounding tissue.  Symptoms have been ongoing since date of administration.
vaccination site pain; Palpitations around 130s; Sense of discomfort; Low energy; Low appetite; Fatigue; A spontaneous report was received from a consumer concerning an 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in his arm, palpitations around 130s, sense of discomfort, low energy, fatigue and low appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events, the patient received his 1st dose of mRNA-1273 (lot batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced soreness in his arm, palpitations around 130s, sense of discomfort, low energy, fatigue and  low appetite. On an unknown date, pulse rate was 120. Treatment for the events included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported. No treatment and concomitant drugs provided. Tthe outcome of event palpitations around 130s was resolved. The outcome for the events fatigue and low appetite was not recovered. The outcome of the events soreness in his arm, sense of discomfort and low energy was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Moderate Swollen face under eyes and chin for 3 days. Had vx on April 7th around 9pm. April 8th got body ache and chills (took Tylenol extra strength). April 9th-April 11th moderate swollen face. April 12th-April 14th mild swollen face. (Took Benadryl 50mg at night).  Called doctor line and Health nurse line who recommended going to Urgent care.
Patient provided information regarding history of asthma, previous allergic reations to animal, perfume, dust, pollen. Also, reported anxiety when she see needle or syringe. When staff asked patient whether she is comfortable to complete her vaccination, patient replied that as long as she do not see the procedure she will be fine. After vaccine administration patient reported discomfort in her throat. Dr. and EMT team were notified. Patient's vital signs were BP 116/72 HR 103 O2 98% RR 18. Patient was monitored for forty minutes, no medications were administered. Patient left in stable condition (vita signs BP 121/70, HR 95, O2 99% RR 18). No hospitalization required.
Within 24 hours after injection suffered flu symptoms fever, nausea, chills, sweating, aches, pain, general discomfort, congestion.
Severe rheumatoid arthritis. Per doc 213847, follow-up parent, site soreness after injection. Joint pain began between 2nd and 3rd dose, with wrist inflammation and sore feet. Seriously inflamed left ankle by 03/09/2001. Rheumatoid factor of 176 of that time. Annual follow up states within a month or so of the first dose of vaccine, pt began having symptoms of chronic inflammatory arthritis. Pt is now taking a lot of medecine for this condition and seeing the head of rheumatology  at the medical center. Pt continues to have pain and stiffness an limited flexibility.
within 15', developed tongue swelling, dizziness, palpitations.  Transferred to ED & treated with steroids, Benadryl, Pepcid.  Observed in ED for  6 hrs, then d/c to home 7 will f/u with PCP re: EKG changes
Left shoulder pain, painful ROM of left shoulder since vaccine was administered on 10/23/2017.
Client reported onset of pain increasing to "8" on 1-10 scale through the evening, overnight and into the next morning.
Fever (max 102.5), chills, sweats, headache, muscle pain, fatigue. Fever started 13 hours after injection. I am now 29 hours post-injection, and fever (as well as all other symposiums) persists.