chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE; Generalized aching/ BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE) (seriousness criterion medically significant) and PAIN (Generalized aching/ BODY ACHES). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE) and PAIN (Generalized aching/ BODY ACHES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not reported. It was reported that Humira did not last the fourteen days. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication were not reported. 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  Company Comment: This is a spontaneous case concerning an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Late the night of injection, I suffered extreme chills that lasted for several minutes followed by several minutes of being unable to catch my breath. The next day, I felt extremely tired and slept for most of the day.  By the following day (third day after receiving injection), I felt much better.
Diagnosed with Polymyalgia Rheumatica.  Being treated with Prednisone 20 mg.
Redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentences. Felt dizzy - taken to ER via 911. Given IVF's/ketorolac and BENADRYL and recovered, sent home.
This study case was received from the investigator in a trial on 18 July 2014. A male subject (date of birth unspecified) had a history of receiving the following vaccination on an unspecified date in January 2003: ACAM2000 (lot number, route and site not reported). On 19 June 2014, the subject also received Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Twenty-five days later on 14 July 2014, the subject was found to have a positive rapid Troponin level I. Lab work from 14 July 2014, the troponin level was <=0.10 ng/ml. An ECG appeared normal and the subject was asymptomatic on an unreported date. The subject did not have any medical history relevant to the event and did not take any medications to treat the event. The subject recovered on 14 July 2014. The subject was in the control group and did not receive the study vaccine during the study period. According to the investigator, no information was expected to become available. Documents held by sender: None.
Sore left arm; This is a spontaneous report from a contactable other HCP. An adult patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 05Jan2021 20:00 at a single dose for COVID-19 Immunization. Medical history included Traumatic brain injury, pacemaker, A-Fib and allergy to amoxicillin, and had covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, lot number EH9899 on 15Dec2020 at 16:15, intramuscular in right arm for COVID-19 immunization The patient experienced sore left arm on 05Jan2021 20:00 with outcome of recovering. there was no treatment required for the said event. The event was assessed as non-serious. Since the vaccination, the patent has the patient not been tested for COVID-19.
metallic taste in mouth began today, not alleviated by food or drink (body aches and fatigue were experienced on the day after vaccination, but that was reported through a text alert system)
18 hours after my second vaccine (moderna) I woke up with a low grade fever, chills, headache, and body aches. That lasted for about a day. The next day I looked at my arm and there was a raised, red, oval shaped mark. It was hard and warm to the touch. I put ice on it and hydrocortisone cream. It was bigger the following day, but seems to be gone now.
SLEPT A LOT THE NEXT 2 DAYS; ARM WASN'T EVEN SORE FOR MORE THAN AN HOUR; TIRED; This spontaneous report received from a patient via a company representative concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus autoimmune illness, and celiac autoimmune illness. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-MAR-2021, the subject experienced arm wasn't even sore for more than an hour. On 17-MAR-2021, the subject experienced tired. On 18-MAR-2021, the subject experienced slept a lot the next 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm wasn't even sore for more than an hour on 17-MAR-2021, and the outcome of tired and slept a lot the next 2 days was not reported. This report was non-serious.
None. Patient given vaccine stored in a conventional freezer for > 2 weeks. Offered another dose.
a fever that spiked up to 103°F; a rash that broke out; neck was swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported by the patient that after receiving the first dose of vaccine the patient experienced a rash that broke out, neck was swollen and a fever that spiked up to 103 degree Fahrenheit. The patient underwent lab tests and procedures which included body temperature which was spiked up to 103 degree Fahrenheit. The outcome of the event was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 17 year old male patient. On 10-OCT-2014, the patient was inadvertently vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). No adverse effects were noted. Additional information has been requested.
Patient was in a seated position when HPV9 was administered; Immediately after vaccine administration, patient had a syncopal episode and his body jumped three times resembling a seizure.  He came to in about 2-5 seconds complaining of nausea, weakness and his face was pale.  Patient was then carefully transferred to laying position on the exam table until the episode passed.  He was then transferred to emergency department in a wheelchair for evaluation.
ENTIRE LEFT ARM SWOLLEN AND PAINFUL, UNABLE TO USE FOR DAILY ACTIVITIES. BODY ACHES AND CHILLS. STARTED APPROX. 5 HOURS AFTER INJECTION, AND SYMPTOMS PERSIST. INSTRUCTED BY PCP TO USE ZYRTEC, BENADRYL, NAPROXEN, REST AND ICE/HEAT PRN.
Patient states mouth and tongue went numb immediately after shot. Patient said mouth numbness has worn off but tongue is still numb and patient has been experiencing headaches as well.
Burning itchy red rash on both lower forearms, behind both elbows, upper rear end, lower front thighs around knees, tops of both feet, right eye clouded and bloodshot
After second dose I started to feel back pain, shoulder pain, joint pain, headaches and tiredness. Still having joint pain, headaches and tiredness.
moments p/vax pt lost consciousness w/eyes open & stiffness in limbs;BP dec episode lasted 5-10seconds;pt lied down & fluids were given until BP came up & situation was resolved;
VACCINE FROM OPENED VIAL WAS ADMINISTERED PAST THE SIX HOUR USE BY TIME FOR OPENED VIALS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 15-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-NOV-2021, the patient experienced vaccine from opened vial was administered past the six hour use by time for opened vials. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine from opened vial was administered past the six hour use by time for opened vials was not reported. This report was non-serious.
Fatigue for approx 36  hours Cognitive impairment ?brain fog?  lasted about 5 days
Called into Covid hotline 2/10/21 about an exposure to a covid + coworker. In obtaining the history, offered that she received #2 Moderna on 1/26/21. Reports fatigue, myalgias 24-48 hrs post vaccine. Also tingling in bilateral feet x 4 days post vaccine which she also experienced x 4 days after #1 Pfizer.  Approx 24 hrs post vaccine, experienced one acute episode of SOB and a sensation of choking. Describes a sensation of her "neck closing in." Denies swelling of lips, tongue, throat. She called 911, was taken to ED. Episode resolved after 10-15 min en route to ED, was given O2 in ambulance, IV fluids, Tylenol in ED.  Labs, EKG, CXR WNL. ED states patient "likely is feeling effects of 2nd Coivd vaccine."  was d/c'd home. felt "great" the next day and went to work. No similar sxs since this event. Smoker 1/2 ppd x 35 yrs.
Localized reaction, approx. 2 in diameter raised red bump. Treatment: BENADRYL topical cream. Sym decreasing after 24 hr. Still hard lump at injection site. MD's following up.
Awoke at 2am with complaints of body aches, pain with walking, fever 102F, hot flashes.  Said skin painful to touch.  (had Td 06/27/05 due to cut on back of RT foot at work on 06/27/05)
Pt received second dose of Pfizer vaccine. While in shot watch area, she stated to the observer that she had a dry throat and felt slight swelling. Pts vitals were taken 0816: BP 122/77 HR 77 O2 100 0831:  BP 103/70 HR 68 O2 100 0846:  BP 109/76 HR 64 O2 99  Pt did not want to go to the ER, stated swelling was better before leaving.
RIGHT LEG RED SPOT 1IN BY 3/4IN THEN SWOLLEN ALL AROUND AND HOT TO TOUCH.
Pt developed inconsolable crying within 12 hours of 4 month immunizations. She also had a fever of 103F for 48 hours.
Not having period; Fatigue; Coughing; Started getting sick; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 44-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 06May2021 (Batch/Lot Number: EW0773) as dose 1, single for COVID-19 immunisation. Patient medical history included skin infection. Concomitant medications included prednisone for skin infection, 20 mg tablet once daily from 22Apr2021 to 01May2021. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that, she had diarrhea starting on 06May2021 for 2 weeks, that just stopped on the 21May2021. She started getting sick two or three days after vaccine on 10May2021 at around 09.00 AM. She did not know if it was related or not. She had been sick for almost three weeks and had several different symptoms. She was never sick and never had the flu or cold in 3 years and after the covid vaccine she was sick in 3 days, it was on-going, it got worse a week after it started, around 18May2021. She was having fever every morning and she took Tylenol and the fever went away but it came back every morning, She also experienced fatigue, and cough on 13May2021. She was wondering if she should get the second dose or not as she was due for it on Thursday. She had no treatment, just self-treatment like Tylenol, she didn't go to doctor. She was not having a period. She always took her birth control and was regular and she should've started her period on Sunday and she hadn't started yet. She knew she was not pregnant. The outcome of the event of diarrhea was recovered on 21May2021. The outcome of the events of sickness, fatigue, fever and cough was not recovered. The outcome of not having period was unknown.  Follow-up attempts needed. Further information is expected.
Tiredness; Stomach ache; Nausea; Sore arm; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th June 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and headache. On 27th June 2020, the patient experienced stomach pain and nausea. On 28th June 2020, the patient experienced tiredness. On 29th June 2020, the outcome of the pain in arm, headache, stomach pain and nausea were recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, stomach pain, nausea and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed sore arm, headache, stomach ache, nausea, and tiredness in the days following the vaccine. The patient had recovered from symptoms except the tiredness. The reporter did not consent to follow up.
Four hrs after receiving immunizations, pt developed crying, irritability, and slight swelling of the right leg. Two days post immunizations, 4/11/01, pt's right thigh was noted to be swollen, reddened and inflamed, and he had a fever. He was immediately hospitalized for 24 hours and treated with IV antibiotics. He was diagnosed with cellulitis of right leg.
A few days after injection patient developed fatigue, body aches. 1 week after injection patient developed a bad right sided headache that ache and burned and felt like nerve pain. She reports she is still tender over the right side of her face which is slowly resolving. She is also noticing eye pain on the right side. No rash
Patient received second booster dose 1 month too early. Patient is not considered immunocompromised upon assessment. Patient waited in recovery for 30 minutes with no issue.
episodes of dizziness; fatigue; moderate headaches; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 12Apr2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received iron supplements within two weeks of vaccination from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:00, the patient experienced episodes of dizziness which lasts about 2 -5 minutes. Her body was still fatigue and had moderate headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events episodes of dizziness, fatigue and moderate headaches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Received third full dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received third full dose without being immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ACCIDENTAL OVERDOSE (Received third full dose without being immunocompromised). In September 2021, ACCIDENTAL OVERDOSE (Received third full dose without being immunocompromised) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Caller stated that he received a full third dose in September and claims to be a healthy person, not immunocompromised. The third dose was given 7 months after the second dose.   Reporter did not allow further contact
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 years old male patient who was vaccinated with a 1.0 ml dose of vaccine FLUZONE PRESERVED (lot number and Exp. Date not reported) via intramuscular route in the left deltoid on 01-Feb-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to overdose. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Person stated she started feeling faint shortly after receiving vaccination. She says she is feeling well now. Vital signs were monitored.  SPO2 98% HR 62BPM
Information has been received from a physician concerning an over 60 year old male who in January 2007, was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). In approximately April 2007 a "few months after being vaccinated," the patient developed shingles. At the time of this report the patient had not recovered. Unspecified medical attention was sought. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
She got her vaccine, had a lot of muscle aches and tiredness for 48 hours after the vaccine.  Sunday evening she noticed that her left arm and bicep was puffy and sore.  When she woke up on Monday morning 11/21/22 she noticed that she had a rash around the injection site.  Today, she has noticed that the rash has expanded down her arm.  She believes that she has some redness on her chest area which seems to have spread from her arm.  Above her chest under her neck region.  Her husband is a physician and was concerned that it might be a cellulitis.  He looked it up on the CDC website and saw that other people have had a similar reaction.  She has not taken anything or put anything on it.
Baby had vaccines on 3/11/17 and the next morning began having significant apnea/brady/desat episodes and visible seizures eventually requiring resuscitation and intubation.
no adverse effect reported; the patient received improperly stored PROQUAD; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a 4 years old female. On 26-NOV-2018, she was vaccinated with improperly stored varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012374: US-009507513-1908USA012377: