chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vax administered Thursday at noon Thursday evening, chills, slight fever (99.9), body aches Friday morning at wakeup (530am), woke up with fatigue, body aches. Continued through bedtime (9pm) Friday night Saturday morning, fever, body aches were better, but stomach was upset (not nausea, but unsettled.) Diarrhea started at 930 am. Sunday, unsettled stomach, diarrhea. Monday, unsettled stomach, diarrhea, and body aches are back. No fever or chills. Treating with fluids (water, tea and gatorade), soup, crackers, bananas, Aleve for the body aches.
headache, light headedness, nausea, muscle aches, joint aches, lymph node swelling, fatigue, swelling at the injection site.  All symptoms lasted about 48hrs.  The swelling and bump at the injection sited lasted 1 week.
Adverse effect of other vaccines and biological substances, initial encounter, Other complications following immunization, not elsewhere classified, initial encounter on 2020-12-30.
The evening of her vaccine she developed jittery feeling (worse than having too much caffeine), felt like her muscles were jerking, feeling unbalanced and uncoordinated (almost fell on stairs) due to vertigo sensation and whole body weakness. A feeling of being both "drunk and high". Word finding has been harder, but this is part of her baseline. Some numbness into left hand, 4th and 5th digits only.
Red rash with itchy skin and stiff muscles in area of injection site. Symptoms lasted for 7-10 days. Was given doxycycline as treatment.
Patient's arm is incredibly sore after receiving 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient's arm is incredibly sore after receiving 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient's arm is incredibly sore after receiving 1st dose). At the time of the report, VACCINATION SITE PAIN (Patient's arm is incredibly sore after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.   Patient wanted to know take pill for event.   Reporter did not allow further contact
Sudden onset upset stomach, diarrhea, nausea, dizziness. Within 5 minutes I defecated, dizziness and weakness increased and I fainted. Woke up within minutes on the bathroom floor with a lump on my forehead. More diarrhea ensued.
Hives at and around the injection site of each vaccination 24 hrs. after vaccination.  No treatment denies fever or difficulty breathing.
Feeling very lethargic at the end of the day; didn't even have the strength to make it to planned dinner with family and friends. Was ok after a couple of days.
He got sick; Stomach was hurting hurting and so he ended up having terrible diarrhea; Stomach was hurting hurting and so he ended up having terrible diarrhea; Explosive throwing up; Muscle spasm for about 5 minutes; There is a stomach bug going around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 08:45 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious) all with onset 24Mar2021 19:00, outcome "unknown" and all described as "Stomach was hurting hurting and so he ended up having terrible diarrhea"; VOMITING (non-serious) with onset 24Mar2021 19:00, outcome "not recovered", described as "Explosive throwing up"; MUSCLE SPASMS (non-serious) with onset 24Mar2021 19:00, outcome "recovered" (2021), described as "Muscle spasm for about 5 minutes"; GASTRIC DISORDER (non-serious) with onset 24Mar2021 19:00, outcome "unknown", described as "There is a stomach bug going around"; ILLNESS (non-serious), outcome "unknown", described as "He got sick". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, vomiting, gastric disorder. Therapeutic measures were taken as a result of muscle spasms.  Additional Information: Reporter stated, husband got the shot yesterday morning at 08:45 and then last night at 7, he said his stomach was hurting and so he ended up having terrible diarrhea and explosive throwing up, he has muscle spasm for about 5 minutes, he has been throwing up previously for about 45 minutes. He got him some water and then his muscle spasm stop. There was a stomach bug going around, so he was trying to figure out did he had a bad reaction and he need to take the second vaccine or he is throwing up with the vaccine, just like normal throwing up, I am trying to find if he had a bad reaction or probably he just had a stomach bug. He had a first shot yesterday morning at 8:45. Reporter stated, He did not have a doctor. He is a police officer. No I do not. He got the card on him. When probed if patient had the COVID Vaccine as a preventive measure of COVID virus, reporter stated, Yes. Reporter stated, He woke up this morning and he was fine. He started throwing up at 6 pm. He got sick at about 7 pm and then throw up the last time at 1 am.  No follow-up attempts are possible. No further information is expected.
I started with the chills at 11 pm the night after the shot which was still happening the next day and night off and on.  I had a headache for 2 days after the shot and was very fatigued with loss of appetite.  I am still fatigued 3 days later and I have no desire to really eat anything.  I can smell and taste but just don't care about eating so I am concerned.
Pain at injection site for less than 24 hours.  Feeling flush-hot and then cold/clammy the 2nd day after shot.  One week after 4th dose,  felt slight headache , sore throat, tickle in throat and congested.  On the 8th day  after 4th dose, woke up feeling like I had the flu.  Took a home COVID test (Binax) and the result was positive.  Did a video conference with Dr at urgent care clinic.  She advised that I drink lots of fluids, get plenty of rest, take extra vitamin supplements, use over the counter medicine as needed to relieve symptoms.  I told her that my head felt like it was going to explode, the pressure was intense and I could not breathe through my nose.  I had taken a Sudafed the day before hoping that it would help with the congested feeling but it did not seem to phase it.  She prescribed me  Bromphen/pseudo/dextro HBR syrup to take if I started coughing and it would help with my congestion.   I took it Friday twice , several times on Saturday and just twice on Sunday.   I stayed in bed Friday, Saturday and most of Sunday.  I never ran a fever and on Sunday, the  12th I was finally able to breathe through my nose.  I coughed just a little bit but nothing ever came up and it never felt like it was in my chest.  It was more like clearing my throat.   On Monday, three days after I tested positive , I woke up and felt 90% better.  On Tuesday it was like I had never been sick.  I have noticed that I tire easily but everyday is better.
Shortness of breath; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up was received on 25-MAY-2021 contain no significant information
Rash, UrticariaPruritus, redness at injection site, rash on torso Narrative:
mom stated started unconsolable crying w/in 1 1/2hrs;lasted 1 1/2 days;not seen by PMD;given APAP
soreness and achiness in left upper arm on the posterior and medial aspects, not in the injection site.  Over the next few days pain increased and reduced ROM in left arm (could not raise arm much above shoulder level).  Physician exam on 10/31 demonstrated some soft tissue swelling in the posterior left upper arm.
After receiving the vaccine he felt his breathing was abnormal. He has not taken any of his medications this morning.  HIS VITALS ARE BELOW. HE WAS ALL SET TO LEAVE TO GO HOME AND THEN HE STARRED INTO SPACE FOR A SECOND, HIS ENTIRE BODY SHOOK, AND IT SHOOK THE VEHICLE HE WAS IN. IT TOOK A SECOND FOR HIM TO COME OUT OF IT AND HE SAID IT WAS ANXIETY AND IT HAD HAPPENED ABOUT A YEAR AGO. WE EXPLAINED OUR CONCERN IF HE HAD BEEN ON THE ROAD WHEN THAT EPISODE OCCURED. HE AGREED TO GO TO THE EMERGENCY ROOM FOR FURTHER EVAL.
pt recv vax & devel lymphadenopathy described as golf ball size lumps in the axilla of the arm into which vax injected;this is 1 of 5 pt from this facility to exp this event p/vax;
Upset stomach, nausea, vomiting, dizziness, dehydration, fatigue.
On 01/14/2021 patient experienced severe chills and shaking upon awakening. She subsequently vomited three times following the episode of chills and shaking. Later in the day the client experienced two episodes either extreme fatigue or fainting - she is unsure of the nature of the events since she does not recall falling asleep, and both events occurred in her vehicle while parked.
Lethargy, weakness, headache; ultimately pronounced on 4/3/2021 at 1310 hours
Diagnosed with shingles 6 days after symptoms started on April 9, 2021.  Treated with antiviral prescription and Tramadol for pain.
tested positive for COVID-19 that same day; tested positive for COVID-19 that same day; This is a spontaneous report received from a contactable consumer, the patient reported a 54-year-old adult male received the first dose of BNT162b2 (solution for injection; batch/lot and expiry not provided) as a single dose via an unspecified route on 19Mar2021 for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient reported that he got his first shot on 19Mar2021 and he was scheduled for his second shot on 09Apr2021 and also tested positive for COVID-19 on that same date. The patient reported that he was voluntarily tested at work. The patient wanted to know if he can get the second shot or does he need to wait. The outcome of the event tested positive for COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up
Patient was scheduled for a flu shot and was incorrectly given a Covid shot instead.  He had already gotten his booster dose.    He reported no adverse events from the incorrect vaccine.
Information has been received from a registered nurse concerning a male child with no past medical history, who on 07/17/1997 was vaccinated with varicella virus vaccine live. There was no concomitant medication. The child subsequently developed varicella. It was reported that the child's symptoms began on 12/20/2001. The symptoms were described as generalized rash, not severe, and required only comfort treatment. Per a letter from the child's school. It was reported that the child had been exposed to children with varicella at school and had close contact with some of them. Unspecified medical attention was sought. At the time of this report, the outcome of the varicella was unknown. Additional info has been requested. The nurse also reported that the sister of this pt also developed varicella following vaccination with varicella virus vaccine live (WAES0203USA01717).
an expired dose of ACTHIB to a patient with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3-years-old male patient who was administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On an unknown date in Oct-2023,  the patient received expired 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ801AA; expiry date: 05-Oct-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Dizziness ,nausea, diarrhea, first and second day . Blurred vision still present sometimes.  Very steep drop in blood pressure. I?m  treated for high BP with Norvasc  , but after vaccine mu BP was 102 / 46  and is still like that at night .  During day time became very unstable . Very disturbing side effect was vaginal bleeding on the 3rd day after vaccine .  Never happened for 20 years post menopause .
pain and swelling  in right arm with severe swelling and severe pain in right hand and wrist.  pain and swelling appears to affect joints as lower back and fingers on left hand has become swollen and painful several days after injection
Information has been received from a physician concerning a child who was vaccinated with a dose of varicella virus vaccine live. Recently, the pt developed breakthrough chickenpox. The pt was seen by the physician. At the time of this report there was no further information regarding this pt. No product quality complaint was involved. Additional information has been requested.
Pt recv vax on 2/24/98; 1 hr later pt exp fever (101-102F), headache, stomach ache, tiredness & decreased appetite; tx=Motrin
No additional AE reported; HCP reports patient received the second dose of VAQTA ten days before six months after the first dose. Patient received first dose of VAQTA on Jun 15, 2012. Patient received second dose of VAQTA on Dec 7, 2012. No further information provided. This i; This spontaneous report has been received from a medical assistant, regarding an identifiable patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were unknown.  On 15-JUN-2012, the patient was vaccinated with the first one dose of Hepatitis A Vaccine, Inactivated (VAQTA) vial (lot number reported as 1647AA which was confirmed as valid, expiration date not provided but stablished as 23-SEP-2014), and on 07-DEC-2012 with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) vial (lot number reported as 0273AE which was confirmed as valid, expiration date not provided but stablished as 06-DEC-2014), both administered as prophylaxis (strength, exact dose, route of administration and anatomical location, lot number and expiration date were not provided); the second dose was administered ten days before six months after the first dose (inappropriate schedule of product administration). No adverse events reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA009121:Case number: 02195271
2wk p/vax pt exp hands, feet, face swelling & urticarial rash-worse in warm temp;
11/26, started working out for the first time since giving birth 10 weeks prior. An hour later broke out into a rash. Then rash progressed into hives. Took a shower and rash got worse. Took zyrtec, got better and then the hives continued to spread. Exercised again and the same reaction occurred again.
Sinus congestion and pressure, lightheaded ness, fatigue, fuzzy thought process, injection site swelling/warmth/redness/hardness.
very weak; bones and body started to ache a lot; slight fever; she couldn't even walk, now she can't walk; pain in her left leg, it burns like fire; shoulder hurts, her neck; extremely exhausted; sensation; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), MYALGIA (bones and body started to ache a lot), PYREXIA (slight fever), GAIT DISTURBANCE (she couldn't even walk, now she can't walk) and PAIN IN EXTREMITY (pain in her left leg, it burns like fire) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA (very weak), MYALGIA (bones and body started to ache a lot), PYREXIA (slight fever), GAIT DISTURBANCE (she couldn't even walk, now she can't walk), PAIN IN EXTREMITY (pain in her left leg, it burns like fire), ARTHRALGIA (shoulder hurts, her neck), FATIGUE (extremely exhausted) and DISCOMFORT (sensation). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
aching began in left arm  .Now my left arm is unable to move upwards or backwards without a pain that makes me vocalizethe pain
Moderna Covid-19 Vaccine EUA - Severe dizziness, violent vomiting, fatigue.  Foggy brain and felt horrible.  Could not turn head without extreme  dizziness which lead to vomiting.  Could not move for 20 hours.  Slept all day.  Called doctor twice - prescribed Meclizine. - 12.5 mg.  Could eat or keep down liquids.  Took Tylenol every 4 hours.  Starting improving  morning of 1/18/21.  Still having improved dizzy spells as of 0335 pm.  Still sleeping but able to keep down  food and liquids.   Normal vitals throughout reaction.  Can someone contact me about advice on the 2nd vaccine?
pt arm where inj was given became completely edematous from shoulder to elbow, red;ice, atarax & keflex;
drowsy, diaphoretic   Narrative:  Dizzyness, Drowsy, Diaphoretic 1255-VS-BP=125/75 HR=55 O2=99% "Pre-Diabetic- given apple juice x2 & snack 1300- feeling" "not as dizzy"-responding appropriately to questions 1310 Paramedics here- CBG=157 Pt still c/o dizzy/placed on stretcher-eating snacks
Red blotches with blisters on body Severe arm pain at injection site Headache Stiff Neck General malaise
I don?t know which flu shot I got but I was a young healthy fit person and felt like I had horrible case of flu, extreme malaise, bone joint muscle pain extreme exhaustion not being able to walk pain. Dr said I had a reaction to flu. I also am compound hetero mthfr gene mutation and never been the same
Case previously recorded as MA2009-4070. Initial case report received from a physician via MedCom on 09 NOV 2009. A 13 day-old female patient was inadvertently administered with 0.5 mL i.m. S-OIV FLUVIRIN (batch no. 1008143P) on 06 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007849.
Vax given on 4/17 - Sore, red and itchy, and a little swollen. Saturday swollen and warm.- little fever. Monday 4/20, still sore and warm. Dr. prescribed NEOSPORIN and wash the shot site.  ZOSTAVAX vaccine was administered on Friday 4/17. Same day developed itchiness redness and soreness on the site of the shot. On Saturday 4/18 still swollen, warm, and a little fever. Did not take temperature. On Monday 4/20, still sore & warm. Her Dr. recommended to wash the shot's site and prescribed NEOSPORIN.
She got her vaccine, waited her 20 minutes, came home, finished her yard work.  About 6;30 she felt queazy to her stomach, by 7:00 PM she had chills, fever.  By the time she went to bed she had temp of 101.  The body aches were horrible and was freezing with it being 100 outside.  On Saturday she had vomiting, diarrhea, a lot of dizziness, light headedness.  Started 6/13/21 she had right sided plugged up and cannot hear out of her ear and feels like it needs to pop for her to be able to hear.  Today scratchiness of her voice/laryngitis and soreness.   She had a croupy cough Friday and Yesterday but that has diminished.  She has not thrown up today, but she has had severe headaches during the night, and the tinnitus is better than it was.  Just feels yucky.  She still has no energy and fatigue and is a very active person and does not get temperatures often.  She is no longer running fever, it was 99 degrees.  She woke up in sweats last night, but still has the fatigue.  She took Ibuprofen for her symptoms, and then she took some Excedrin PM as well.
"Covid arm" began on 3/28.  Injection site had large red, bumpy rash.  Also had a headache and arm was tender like the day after the vaccine.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no drug reactions/allergies. Patient's concurrent conditions included: high blood pressure, high cholesterol, depression and diabetes. On 27-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX via intramuscular route, dose not reported (lot# reported as K010628, expiration date: 30-OCT-2015). Concomitant therapies included atenolol, DIOVAN HCT, ZOCOR, CYMBALTA, metformin hydrochloride and clonidine. On 28-OCT-2014 the patient developed hard, red area at the site of ZOSTAVAX injection. The patient sought medical attention, she went to see pharmacist. No treatment was given for the events. No laboratory diagnostic was performed. The patient is recovering from the events. Relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Diarrhea-Medium, Systemic: Exhaustion/Lethargy-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium.
Typical injection site reaction the day of the injection. Nausea that evening. Initial symptoms resolved within 1-2 days. On Day 7 after injection the site started itching and got red again. On Day 8 woke up to much more pronounced swelling and redness at the injection site, as well as N/V. Resolved on Day 9. Treated on Day 8 with benadryl, hydroxyzine, and zophran.
Patient was given 0.5 ml of Moderna 6 mo- 5 yr vaccine instead of 0.25 ml No side effects reported
Raised red rash approx 3in diameter, warm to the touch. No soreness.