chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had severe side effect when received the first covid vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (had severe side effect when received the first covid vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had severe side effect when received the first covid vaccine). At the time of the report, VACCINATION COMPLICATION (had severe side effect when received the first covid vaccine) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Reporter stated that patient lived alone and patient was undergoing chemotherapy and therefore had a thoroughly weakened immune system.   This case was linked to MOD-2022-511048 (Patient Link).
3/26 @ 2:30  Abdominal cramping for one hour, followed by 2-3 hours of diarrhea. Overnight had muscle cramping in legs. 3/27 Fatigue & overall feeling of  distraction. Poor appetite. Headache started in back of head. That evening had joint aches in hips, knees, shoulders, wrists & hands. Then awoke after one hour of sleep with uncontrollable shaking  chills, followed by severe nausea and vomiting that lasted most of the night. Also felt feverish, but didn?t take my temperature until late afternoon on 3/28, it was 99.6  orally. Could not tolerate intake of solids without severe queasy feeling.  3/29 Feel exhausted & weak.  Still feeling queasy with solid food. My injection site @ left upper arm was very sore until 3/29. Soreness mostly resolved.
Initial case was received on 17 June 2010 from a healthcare professional. A 49 year old female patient received a left deltoid intramuscular injection of ADACEL (lot number C3352AA) in the a.m. on 10 June 2010. In the p.m. on 10 June 2010 the patient experienced a headache, chills, photophobia, stiff neck and myalgia. She was evaluated and treated in the emergency department (ED). No ED report was provided. She was evaluated by a family practitioner on 11 June 2010 (no report provided). On 17 June 2010 she was seen by a nurse practitioner. Blood work was ordered including a CBC and comprehensive metabolic panel (results not provided). The patient had no illness at the time of vaccination. Her medical history included a herniated disk, sinus arrhythmia with palpitations and allergies to "MS04", Sulfa drugs and VIDCODIN. She was not pregnant. Concomitant medications included multivitamins, glucosamine, calcium and OPC3. At the time of this report, it was unknown if the patient had recovered. Follow-up information was received 02 August 2010 from a health care professional. The patient had not received any other vaccines within four weeks of ADACEL. A CT of the head was negative and patient declined a neurological follow-up. No treatment was required. All signs and symptoms had resolved as of 26 July 2010, for all but a mild headache. According to the reporter, the patient recovered on 26 July 2010. Documents held by sender: None.
This spontaneous report as received from a certified medical assistant (also provided as nurse) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2016, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M011116, expiration date: 17-JUN-2017 and lot # L023936, expiration date: 15-MAR-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Migraine headache; Flu like symptoms; Body aches; Fever; Chills; Hyperthyroidism; Graves' disease; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (Graves' disease) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPERTHYROIDISM (Hyperthyroidism) (seriousness criterion medically significant) and BASEDOW'S DISEASE (Graves' disease) (seriousness criterion medically significant). On 23-Mar-2021, the patient experienced MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills). On 17-Apr-2021, MIGRAINE (Migraine headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPERTHYROIDISM (Hyperthyroidism) and BASEDOW'S DISEASE (Graves' disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the symptoms were mostly in the night. No concomitant medications were provided by the reporter.   Treatment medications included tylenol and metron.  Company comment: 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.; 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.
I received the 2nd vaccine a week ago (01/26/2021), and I had a rash on my arm which cause swelling, pain in the area and itchy it last for 3 days.
Approx 3" area right upper arm warm, pink sl. firm. Symptoms decrease today with papular at injection site. No anaphylaxis sx - no encephalopathy sx. 4-28 reviewed with Dr.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On 06-JUN-2017 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and the expiration date were not reported) for "vaccine" (prophylaxis).  Other suspect therapies included sterile diluent (manufacturer unknown) lot# and the expiration date were not provided. There was no concomitant medication provided. The pharmacist reported "the patient called on 09-JUN-2017, and reported itching all over (pruritus generalized), injection site bump the size of a silver dollar (injection site mass) and injection site redness the size of a palm (injection site erythema)." The pharmacist also stated the patient was administering unspecified triple antibiotic cream. There was no Product Quality Complaint (PQC) involved. The outcome of pruritus generalised, injection site erythema and injection site mass was unknown. The relatedness between the therapy with ZOSTAVAX and the events was not reported. Additional information is not expected because the reporter refused additional contact.
Patient called to report on going arm pain, possible inflammation with involvement of rotator cuff.  Patient has seen primary provider who suggested involvement of rotator cuff. Patient and provider are in monitoring mode to see if issue resolves.
3-13-15 vaccine given, soreness at injection site; extensive bruising in upper left arm; numbness in entire left arm; severe pain day and night; no relief w/prednisone. 5/4/15 surgery-left shoulder.
Noticed Red dark tender reaction to right upper arm in reaction of the vaccine. Right arm positive 3.4cc erythematous warm/hot plaque, TTP, +FROM strength 5/5  Cellulitis. Received Aleve and Clindamycin.
This spontaneous report as received from a pharmacist refers to an unknown number of patients who on unknown dates were vaccinated with TD (manufacturer unspecified vaccine) and PNEUMOVAX23 which we stored for up to 228 hours/19 days at 8 hours each day at a highest temperature of 14C. There were multiple excursions and the caller did not have any information on lot numbers. expiration dates, number of patients or when/if they were vaccinated. No adverse effect was reported. Additional information is not expected.
Muscle pain; Joint pain; Almost like a burning sensation; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 05Mar2021, at the age of 70-years-old, (Lot Number: EN6201) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 05Mar2021, the patient experienced muscle pain, joint pain, almost like a burning sensation. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Additional dose of Tdap given mistakenly.  Did not see that she had received a dose on 9-21-21 and therefore did not require this dose.  No adverse effect reported. Spoke with parent to let them know of error.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-395985 (Patient Link).
pt recvd vax; lost consciousness for 10 secs; BP elev, P 40 immed p/ vax; tx w/ DPH po;
Clinical Summary Patient is a 66 year old  female with a history of COPD (baseline 4-5L NC), CAD (s/p CABG), chronic HFpEF, T2DM, HTN, and multiple recent admissions for COPD and CHF exacerbations last 7/28/23-8/2/23 for same. Patient represented to hospital on 8/9/23 with persistent SOB. Labs and imaging on admission: Cr 1.4, Trop 32, NT-Pro BNP 10k, WBC 11.9. CXR diffuse pulmonary edema with inflammatory changes possible pneumonitis. Patient found to have Covid-19.    1. Covid-19: pt endorsed worsening SOB and cough with green sputum 3-4 days PTA. Covid-19 on admission. Vaccinated. CXR on admit with diffuse pulmonary edema with inflammatory changes possible pneumonitis. Improved with pulmonary hygiene, diuresis. 1. Covid-19: pt endorsed worsening SOB and cough with green sputum 3-4 days PTA. Covid-19 on admission. Vaccinated. CXR on admit with diffuse pulmonary edema with inflammatory changes possible pneumonitis. Improved with pulmonary hygiene, diuresis and steroids. Continued decadron (end 8/18/23)  2. Acute on Chronic Respiratory Failure: Baseline uses 4-5L NC, stable on admission. CXR as discussed above. Suspect multifactorial in setting of Covid-19, acute CHF and underlying COPD. Continued treatment of underlying factors. Improved. Requiring 2-3L on discharge.  3. Acute on Chronic HFpEF: Follows with Heart Failure Clinic as an outpatient. Last TTE on 7/17/23 with RV slightly decreased dysfunction. NTProBNP on admission 10k. CXR with pulmonary edema. S/p IV Lasix, transitioned to PO Bumex last admit and HDMC followed at that time with increased bumex and added spironolactone on discharge. IV Lasix 20 on admit, and 8/10/23 with improvement. Continued home diuretics. 4. Remote COPD Exacerbation: Follows with outpatient pulm. S/p steroid, azithromycin last admission for exacerbation. No current AE on admit. Steroids as discussed. Continued home inhalers. Outpatient follow-up with pulmonologist. 5. Leukocytosis: Afebrile, WBC 11 on admit. Procal low risk. CXR without concern for pneumonia. Monitored.  6. CAD: per history, s/p CABG. Continued DAPT and statin.  7. CKD stage 3b: Baseline Cr 1.31.4. Admission Cr 1.40. Avoid nephrotoxic meds. Monitored.  8. NIDDM2: Last A1c 6.9 on 6/23/23. Held home orals. SSI on admit. Monitor and titrate PRN. 9. Generalized Psoriatic Rash: Follows with Dermatology as an outpatient. 10. HLD: per history. Continued statin. 11. Hypothyroidism: Continued Levothyroxine.
sore arm - right arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm - right arm) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (sore arm - right arm) and HEADACHE (headache). On 02-Mar-2021, MYALGIA (sore arm - right arm) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-083276, MOD-2021-083116 (E2B Linked Report).; 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. MOD-2021-083276:Wife case MOD-2021-083116:Second dose
Pt received injections 10/25/06. Flu and HPV in one thigh. Tdap and Menactra in other thigh unk which thigh each given. Pt then went to allergist and received allergy injection in each arm. Admitted 10/26/06 for fever 103, dehydration and muscle cramping, sent home 10/27/06. DC DX: allergic reaction.  2 day history of fever. On same day as immunizations she received routine allergy shots. Immunizations received in thighs and allergy injections in arms. Complained of arms puffed and welted evening prior to admission, became painful. Also blotchiness on legs. Complained of pain in legs. Headache since immunizations, myalgias and arthralgias especially to shoulder area. Neck pain, prickly sensaton in feet. Previous immunization reacion 3 weeks ago with pain and symptomatic problems.  PMH: environmental allergens. Eczema. Roavirus at age 2  months. PE: Extremities, there is injection site visible. No rash, erythema or exudate noted around the injection sites. No other rashes.
Suspect "arthus reaction," seems to be at site of Pneumovax. Had intense local soft tissue induration as well as profound malaise, fatigue, constitutional symptoms.
1.  Swelling under left armpit, felt a lump for 10 days.  2,  Swelling by the left clavicle at base of neck that has mostly gone away.   Applied mostly cold and hot compress for first four days twice a day.
Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid-day. Monday night noticed canker sore on the gums in the mouth which gradually resolved over the course of the next few days. On Thursday I noticed a small rash on the left side of my upper back. Within next 48-72 hrs multiple blistery patchy rashes developed on the left lower back, hip and groin. The rash is painful and tingly.  Dr. visit on Tuesday (2/2/21) diagnosed/confirmed shingles. Valacyclovir was prescribed by MD.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 16:00 as dose 1, single (Lot number: EN6203), in right arm, on 27Mar2021 at 16:00 as dose 2, single (Lot number: EN6207), in left leg and on 27Dec2021 as dose 4 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Jul2021 as dose 3 (booster), single (Lot number: 206A21A), in left leg for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Apr2022 at 12:00 as dose 5 (booster), single (Lot number: 001Mz1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing), notes: Other medical history: Lymphoma. Known allergies: No. Other medication in 2weeks: Yes. Concomitant medication(s) included: ATORVASTATIN; ZOLPIDEM; FINASTERIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; negative, notes: tested negative on day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event start date: 05May2022 at 06:00 PM. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 26Apr2022, Treatment stop date: 30Apr2022 and Indication: Treatment of COVID-19. Adverse event: patient took 5 days of Paxlovid and felt all better and tested negative on day 7, then got congested on day 11 and tested positive again.
24 hours after shot thirst and fatigue, then fever of 104 x approx 10 hours. Fatigue lasted 48 hrs. Right arm swelling and erythema 8" x 7 1/2" Pt says this was better then the previous day, he was not sure when it started but noticed it 24 hrs after shot.
8 yr old presents to clinic for immunizations, this 8 yr old given TWINRIX (Hep A and B) x 2 dosage on 3-16-08 and 4-16-08. CSC called. Recommended to give Hep A #3 10-17-08 and Hep B #3 7/16/08. Doctor also agreed with recommendation.
Patient determined to be pregnant May 17, 2003 with E date of conception April 3, 2003. <4 week after vaccine
Approximately 8 hours after receiving the vaccine I had severe abdominal pain followed by diarrhea. I then developed chills, fever up to 101, headache, severe nausea, vomiting, body aches, fatigue, joint pain, swelling to lymph nodes in right armpit.  After approximately 24 hours, the fever, abdominal pain and diarrhea resolved. Today is day 4 since vaccination and I still have swollen lymph nodes, joint pain, headache, nausea and fatigue.
In the same evening as the Pfizer booster, he starting feeling chills and slight headache, felt dizzy and fell down, was not injured by the fall. Symptom severity worsened the next day. Other symptoms reported include cough, sore throat, runny nose, impaired sense of taste, and fatigue. Went to urgent care on 12/1/2022 and tested positive for COVID-19.
I am a well 80 year old woman.  I have no preexisting medical conditions.  I take no prescribed drugs or over the counter medications.  I had no side effects for shot one.  The second day after shot two I had a very very severe headaches for 22 hours.  When I tried to drink water , it came right back up.  I could not keep anything down for the same 22 hours.  I am now fine.
On 12/10/00 at 4 AM, the patient woke up with symptoms of diarrhea (approx 6 episodes) in a short time. Took Immodium. Same scenarios on Monday and Tuesday (12/11 & 12/12) of 2-3 episodes in the morning and early evening. Contacted HCP: informed them of many cases of diarrhea. Advised to take 3 doses of Immodium on Tuesday. No diarrhea today 12/13/00.
Patient received 2nd covid-19 vaccine on 3/2 and day after had acutely altered mental status along with fever of 104 as measured by EMS. He reported feeling very weak and was found crawling in dirt outside. Was brought to hospital and T was 102, also found to have acute kidney injury on CKD. Fever resolved with tylenol and pt was treated supportively with IV fluids with improvement in mental status and resolution of fever. Weakness still present day after admission.
3 days later I ended up at the hospital, the neighbor had to drive me. I think it was a hospital. I walked up 3 flights of steps and when I got up I felt heavy on my chest, as if someone was standing on it, I couldn't catch my breath. When I got dressed it got worse. I called the doctor and he said to go to ER and I went to my neighbor who drove me to the ER. At the ER, they gave me oxygen for 6 hours. 2 days prior to the vaccination, I had a negative covid test from an MD, the DR had shoved the swap really deep to your throat. And after that I had nasal drip for 2, everything I ate, drink, swallowed made me cough for 20minutes- that slowly went away. I had it done because I work out of a wellness center and one of the doctors had tested positive the day before.  While I was there I felt extreme heaviness on my chest, it felt like muscle spasms in my lung, the heaviness would build up really fast and to the point I was grasping for life. And then it slowly just stopped and I went home. I felt weak and couldn't function for a couple of days. The night of the shot, I had a temp of 104 degrees. Dr. said all tests came out clear and wasn't sure what happened that there were multiple patients in the ER with the same symptoms but with nothing in their chest like with me. She advised that I do not get the second vaccine. memory loss----- I had subtly and increased memory loss. I would leave the kitchen to get what I needed go to the basement and then forget why I was in the basement. This was happening randomly. Then it started increasing so rapidly to the point I started questioning why this was. I went to the acupuncturist and he suggested I go to a homeopathic doctor. And they gave me some new supplements which I've now been taking for the past week and still have memory loss episodes. It increased so fast in a 30 month window.
Initial misuse report received from health care professional on 16 April 2013. A dose of DAPTACEL and IPOL was administered 3 weeks early prior to 4th birthday of patient on an unspecified date. Thus, received vaccination at inappropriate schedule. No adverse event was reported. List of documents held by sender: none.
Child had been awake and alert. Feeding well. Witnessed tonic clonic seizure with apnea.  EMS called; CPR started and pt transferred to local hospital with eventual transfer to another hospital.
Information has been received from a nurse practitioner concerning an 18 year old female patient who on an unspecified date, the patient had 2 separate doses of GARDASIL (Lots#: not reported) and on 11-AUG-2010, was vaccinated IM with the third dose of GARDASIL (Lot#: not reported). The nurse practitioner reported that on an unspecified date the patient developed HPV. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
sore arm during day of vaccination. twenty-four hours after vaccination, arm swollen and slightly reddened, lasted 1 1/2 -2 days. Pt also felt like had mild case of flu