chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could not think straight; COVID-19; 1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021; This spontaneous case was reported by a patient and describes the occurrence of THINKING ABNORMAL (Could not think straight), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021). On an unknown date, the patient experienced THINKING ABNORMAL (Could not think straight) and COVID-19 (COVID-19). At the time of the report, THINKING ABNORMAL (Could not think straight) had not resolved and COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021) outcome was unknown.            No concomitant product was reported. It was reported that the patient could not think straight. She was in a fog and was coughing, had COVID. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
SHOT WAS ADMINISTERED AT 11:15 AM ON 12/13/19. PATIENT CAME BACK AT 3:45 PM COMPLAINING OF SYMPTOMS INCLUDING PAIN, HEAT, ITCHING, SWELLING, AND A HEADACHE. PATIENT BLOOD PRESSURE WAS THEN CHECKED AND WAS 192/91.PATIENT WAS THEN ADVISED TO GO TO LOCAL LITTLE CLINIC TO BE FURTHER EVALUATED DO TO SYMPTOMS AND INCREASED BLOOD PRESSUE.  PATIENT WAS COUNSELED ON HOW TO TREAT SYMPTOMS WITH HYDROCORTISONE CREAM AND BENADRYL.
Pt had received first 2 CoVid 19 vaccines by Pfizer at his workplace. He came to 9-1-2021 clinic for his 3rd dose of CoVid 19 vaccine. He received the Moderna CoVid 19 Vaccine instead of the Pfizer Covid 19 vaccine.
1 day p/vax pt devel swelling lt deltoid & redness-15x16cm indurated, sl tender given DPH & ice;now better 2 days later (8.5 x 9.5cm);
patient reported the development of a metal smell about 2 days after they received their second covid shot. Which has not yet resolved. The patient had expected vaccine reactions (fatigue and headache) which resolved within a day of getting the vaccine
Developed sharp pains that came from his left heel up through his left thigh that came in waves and started about 12 hours after first dose.  Lasted about 24 hours.  This was a severe exacerbation of his underlying neuropathic pain.
Patient initially presented with postvaccination symptoms (initial vaccine was on 11/22/21 was given by medical assistant) via message on 12/9/2021 experiencing soreness in her left shoulder joint.  She has not had any previous flu reactions.  She was surprised at the time of the reaction due to her significant pain.  She had difficulty with deep joint pain and ADLs such as difficulty pulling her shirt off, putting her hair in a ponytail. At that time we recommended seeing a provider for ongoing joint pain however patient did not follow-up. She was then seen again on 5/23/2022 during her annual physical exam complaining of ongoing L shoulder pain since her flu shot the previous fall. Some of this has resolved with passive range of motion exercises however she continues to struggle with flexion of her left shoulder past 90 degrees and abduction of her left shoulder.  Denies any changes in strength or sensation.  No previous injuries, traumas or surgeries.  Physical exam revealed:   Inspection of the left shoulder reveals no deformity, asymmetry, bruising, swelling or erythema. Full range of motion of bilateral shoulders to flexion, extension, internal rotation, external rotation. Strength 5 out of 5 in bilateral upper extremities Sensation intact bilaterally in upper extremities. No tenderness to palpation of L shoulder POSITIVE empty can test in affected shoulder. POSITIVE drop arm test negative in affected shoulder.  No pain elicited on external rotation against resistance. Lift off test negative bilaterally.  Suspected etiology at that time related to history and physical exam was a supraspinatus dysfunction/ rotator cuff syndrome.- unclear link to her flu shot however it did present immediately following administration (2 weeks later).  Recommendation at that time to proceed with physical therapy- referral was placed. Patient continue to have pain and has not been seen in our clinic since then.
Woke up 12/16 with tickle in my throat that made me want to clear my throat. Took COVID-19 test because I was going out to dinner and tested negative. Woke up 12/17 with severe sinus congestion and feeling moderate flu like symptoms. Took another rapid test and it turned positive almost immediately. Called PCP after positive test and was prescribed PAXLOVID. Began prescription on evening of 12/17. Symptoms began to resolve. On 12/27 went into PCP for chest pains and it was determined to be muscle skeleton. Went to ER on 12/29 with dizziness, blurred vision, and chest pain. EKG, CBC, CMP, and MG. Pushed normal saline IV and sent home.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-DEC-2015 at 06:38, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.3 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt received 1st dose Ped covid vaccine 11-6-2021 @ 11:00AM. after the vaccine was administered, the pt fainted, falling forward and hitting her head on the ground
Patient reports blood clots discovered in legs and lungs. Total of 3 in leg, 2 in lungs
Nine days after the vaccine was administered I developed red patches around the vaccine shot area on my left arm.  Today, 10 days after the vaccine, my left side of the face is slightly swollen and tender to touch.
burning pain in lt flank;onset 1 hr p/vax;subsided w/in 48hrs;
This case was reported by a lawyer and described the occurrence of mercury poisoning in a 8 year old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and pertussis absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified this report. At an unknown time after receiving Hepatitis B vaccine, DTP/DTaP vaccine, Haemophilus vaccine and/or MMR II vaccine, the patient experienced neurotoxic effects resulting in severe neurodevelopmental injuries. The events were attributed to mercury overdose and poisoning resulting from the thimerosal component of the vaccines. The multiple symptoms of the patient's injuries occurred and were first manifest no later than 01/01/2001. According to the attorney, the patient incurred medical expenses and will continue to incur medical expenses in the future as a result of his injuries. The attorney also alleged that the patient suffered significant impairments in his ability to enjoy life, faces significant obstacles to performing the tasks and activities of every day living, and suffers ongoing physical and mental distress. The case was assessed as medically serious (OMIC).
Child has 1.5 inch diameter area of redness and induration on right tricep area with a more faint area of pink and slightly indurated skin out to about 3.5 inches. Tender with pain
pt recv vax 11:20AM, P92, BP 110/60 pt appears weak, lt arm red 3 1/2l x 1:W;1140AM P 88, BP 106/60;1150AM redness fading, arm tender to touch;given sucker to eat & h20 drink;pt stated used inhaler for asthma & took DPH a/vax;
11/13/21 presents to EC ED for "SOB, lightheadedness" "per patient he was diagnosed with COVID-19 2 days ago". PMHx of "HLD, HTN, OSA, RA, prediabetes".
Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of these were bad, just noticeable, and seem to have resolved in 2 days.
Since I am immunocompromised, I requested FLuBlock to be given when I signed up for this online.  Upon arrival to the pharmacy, I clarified I wanted FluBlock and she nodded her head yes.  In the vaccination room, I asked, again, the pharmacy student who was administering this vaccine, if this was FluBlock.  He answered yes.  The next day I took my paperwork out to look at it and discovered I had not received FluBlock, but Fluvarix.  I called the pharmacy and was told that they did not have FLuBlock in stock and she would report this the team leader, the next day.
Swollen Arm on injection site; Redness Around (Injection Site); Muscle Ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen Arm on injection site), VACCINATION SITE ERYTHEMA (Redness Around (Injection Site)) and MYALGIA (Muscle Ache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen Arm on injection site), VACCINATION SITE ERYTHEMA (Redness Around (Injection Site)) and MYALGIA (Muscle Ache). At the time of the report, VACCINATION SITE SWELLING (Swollen Arm on injection site), VACCINATION SITE ERYTHEMA (Redness Around (Injection Site)) and MYALGIA (Muscle Ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Vaccine was administered to 2 patients from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  The patient received the first dose but the dose was drawn from an expired vial. No side effects were reported.
Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient became nauseous after recieving vaccine. After vomiting patient felt much better. BP low post vomiting but quickly returned back to normal. monitores for 1 hour. Vitals back to normal.
Patient developed fever, itchiness over body, bump on arm and swelling redness that spread from injection site, contacted md and they administered a steroid shot and zyrtec for the allergic reaction. Doctor told patient this was an allergic reaction.
whole body shaking while in bed at 3:30 am,  pain left arm and left leg,  exhaustion next day
It started with a headache. My back started hurting. I had low grade fever. I started having a sore throat. I am a ER doctor so I knew a sore throat could mean Covid. I got tested where I work on 01/03/2022 and it was positive. My back hurt for over a week. The headache and sore throat resolved in a couple of days. I just took some Tylenol and over the counter medications.
received Moderna booster dose(half dose); This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (received Moderna booster dose(half dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Knee deformity (Bad knees) and Immunocompromised.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced UNDERDOSE (received Moderna booster dose(half dose)). On 08-Nov-2021, UNDERDOSE (received Moderna booster dose(half dose)) had resolved.            No concomitant medications were reported.   Treatment information was not provided.    Reporter did not allow further contact
As of 02-NOV-2022;  have had two Atrial-Fibrillation; events occurred on 25-AUG-2022 and 01-NOV-2022;
Extreme pain in right shoulder that night and for 4 to 5 days. Pain tapper off, but two lumps in the muscle were noted.  Sharp stabbing pain in right shoulder remain with certain movements and if resting on the right arm. Have had ultra sound and MRI that are negative for anything. Currently the doctor thinks this could possible be Chronic Regional Pain Syndrome or bursitis because pain remains after more than one month.
Breakthrough COVID-19 case with symptom onset 8/16/2021: Fever, Shortness of breath/difficulty breathing, Nausea/Vomiting, Cough. Hospitalized 8/16/2021 to 9/2/2021. Death 9/2/2021. From Vital Records = SEPTIC SHOCK, COVID-19 PNEUMONIA, Per vital records, Codes include: Not yet coded ; Other Significant Conditions include: None listed. Place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: HCP, PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: .
A consumer reported that her 69 year old mother received an injection of the 2001-2002 formula of an influenza virus vaccine on 11/30/2001. Later that day, she was taken to a local ER for shortness of breath. She was treated with an unspecified "breathing treatment" and was released. The pt has since recovered. No further info was available at the date of this report.
Patient described extreme swelling in arm of injection, redness, hot to touch in injection site/bicep. She now reports trouble moving her arm.
Patient experienced tachycardia 24 hours after vaccine. He was laying down resting when pulse jumped to upper 140s, no other explanation for tachycardia. No cardiac risk factors. Pt is currently in the ER getting tests done
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Chills, Fever of 100.5 po, lightheadedness, loss of appetite, fatigue and pain at the site of injection.
Within about 10 minutes after shot, I started drooling heavily, my jaw became very tight, and had trouble swallowing.   The pharmacist seemed to think it was nothing to be concerned about, but it felt just like a very bad reaction I?d had to prochlorperazine.   The symptom passed about 15 minutes after onset.  But I?m concerned given my history of anaphylaxis and that this is just the first dose.
generalized abd blotches & hives w/in 1hr of vax;rx DPH,  epi given;
Community acquired pneumonia of right lower lobe of lung. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
headache; got very little sleep-suffering; fever; shivering; pain in joints; This case was reported by a consumer and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 16th January 2020, the patient received the 1st dose of Shingrix. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced headache, sleep disturbance, fever, shivering and arthralgia. On an unknown date, the outcome of the headache, sleep disturbance, fever, shivering and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the headache, sleep disturbance, fever, shivering and arthralgia to be related to Shingrix.  Additional details were reported as follows: Patient had fibromyalgia but was not on immune suppressing drugs. The patient received Shingrix and had very little sleep-suffering from headache, fever, shivering, pain in joints. Patient wants to know what should do to reduce or treat these side effects.
Within hours of receiving the vaccination, began to develop rash on torso. By the first morning, the rash covered right cheek, neck, and progressed on torso. By the second morning, the rash covered both cheeks, progressed on torso, and began spreading on arms, and tops of hands and feet. By the third morning, the rash spread to legs and progressed on previously afflicted areas. The rash appeared identical to photos found on internet  of documented cases of measles and of documented reactions to MMR. Throughout this time, patient had a low grade fever and at one point a fever of 100.5. After three days of progression, the rash begin to show signs of improvement on 4/26 and was entirely gone by 4/30.
New Onset Cardiomyopathy with low ejection fraction, CHF, new onset AFIB
2 varicella vaccines were given; Proquad (MMRV) and Varicella.
Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3795AB received on 19 April 2011, lot number C3841AA received on 11 July 2011 and lot number C3923AA received on 07 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough (without a whoop) on 30 May 2012, approximately eight months after the last dose. The subject also experienced sleep disturbance and apnea. Laboratory testing included negative PCR on 12 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 13 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
lightheaded, blackout, overheating, fever, chills, headache, stiff neck, muscle soreness, fatigue
Injection site is bruised on left arm. Below injection site is bruised and red, swollen and painful. Patient thinks the red and bruised area keeps getting bigger. Told patient to go to ER.
HCP called to report that some of the MMR II vaccine got into her eye ( HCP is the affected person) after administration to a patient/ A few drops from the hub is what entered her eye.; HCP states that after flushing her eyes she started to get a headache; This spontaneous report has been received from a health care professional (HCP), regarding to herself, a 66-years-old female patient. The patient's pertinent medical history, previous drug reactions and concomitant medications were not reported. Allergies included to amoxicillin.   On 26-JUL-2023, the HCP administered the patient the entire deliverable dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters as prophylaxis (lot number: X002294, which was determined to be invalid by the validation lot team) (strength, scheme, route and anatomical location of administration were not reported).  After administration, some drops from the hub of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II vaccine got into the HCP's eyes (Occupational exposure to product). HCP states that after flushing her eyes she started to get a headache.   Reporter notes she has no complaints about the quality of the product as she was calling to make sure she did everything she needed to do after exposure. The outcome of the events was reported as recovering.   The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and headache was not reported
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004089: US-009507513-1702USA004091: US-009507513-1702USA004088: US-009507513-1702USA004090.
pt recvd vax 145PM screamed like some one was choking until 6PM non-stop; parent did not call clinic or use ER; told MD about screaming episode when pt came infor physical on 3MAR93;
Developed swollen lymph node on left clavicle four days after the second vaccine.; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EJ1686, expiry date: not reported), intramuscular on 14Jan2021 14:15 at a single dose on left arm for covid-19 immunization.  Medical history included Lupus, kidney transplant. Patient has known allergies Known allergies: Ciprofloxacin, which she got hives with certain cereals and certain granolas.  Patient had his first dose of BNT162B2 COVID-19 vaccine (lot number: Ek5730, expiry date not reported) administered on 22Dec2020 03:00PM intramuscular on left arm. No other vaccine was given in four weeks. The administration was given in  a facility type such as hospital. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE), tacrolimus, prednisone, amlodipine, metoprolol, losartan; all on unspecified date for unspecified indications. The patient developed swollen lymph node on left clavicle four days (18Jan2021) after the second vaccine. No treatment was given. Patient has not rested positive COVID prior and post vaccination. Outcome of the event was not recovered
Moderna vaccine use for COVID-19 under Emergency Use Authorization (EUA): Moderna vaccine (booster shot) Seizure with unclear etiology - possibly fever secondary to Moderna booster shot. No underlying lesions per MRI or obvious metabolic derangement.