chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was feeling fine prior to receiving the vaccine on 1/2/21. After getting the vaccine, 9hrs later I developed a fever of 102 that lasted for 9 hrs, body aches, chills, and vomiting. The fever lasted on and off until 1/4/21, body aches and nausea continued until 1/5/21.
hives, tightness in chest & swelling in throat; 2DEC93 no response to f/u request;
Fever, chills, light headed, dizzy, vomit, severe drowsiness. Started at 2AM about 12 hours after receiving vaccine. Still ongoing today at 2 PM
Significant left axillary lymphadenopathy, not resolving after 6+ weeks. Patient presented to family practice physician with large axillary swelling and lymphadenopathy. Patient had several follow ups with providers and was eventually diagnosed with B-cell lymphoma.
COVID 19 Treatment; COVID 19 Treatment; vaccine_brand_other=moderna/vaccine_dose_number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jun2022 at 12:00 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022 at 17:00, outcome "unknown", described as "vaccine_brand_other=moderna/vaccine_dose_number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti-viral drug Paxlovid from 07Dec2022 to 12Dec2022 for the treatment of COVID-19. The other medication received by patient in 2 weeks was unknown.
(R) leg redness and swelling at vaccine site patient extremely fussy and non-consolable
6 to 7 hours after vaccine administration, Pt started to have tightness and soreness in her Left arm (same arm as vaccination) as well as nausea and abdominal cramping. About an hour or two later, then started experiencing swelling everywhere. States about 12 hours after vaccination, her weight was up about 15lbs. Today, about 30 hours post vaccination, Pt states swelling is only slightly improved, but feeling very fatigued/run down.   All throughout this, Pt denied shortness of breath, throat closing, chest pain, fevers/chills.
severe vomiting, can not eat or drink-numbness in limbs, bones aches-sore all over-does not feel good-dizzy, can't stand up;
After leaving our office, the patient passed out with increase tone. Taken to the ER for evaluation of possible seizure activity. CTScan & blood work all normal. Suspect vasovagal response episode.
The physician also mentioned Rosacia as a side effect.; AE: patient reported to the physician that they experienced a body rash weeks after receiving vaccine.; This spontaneous report was received from a physician via company representative regarding a male patient of an unspecified age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose regimen, lot #, expiry date, and route of administration were not provided) as prophylaxis.  On an unknown date (reported as "weeks after receiving vaccine"), the patient experienced a body rash (Rash). On an unknown date, he experienced rosacea (reported as "rosacia as a side efect"). It was unknown if any laboratory was performed or if any treatment was given for the events. The outcome of the events was unknown.   The causal relationship between rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. The causal relationship between rosacea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was related.
no adverse event, booster dose bivalent given as 1st vaccine in 2 dose series. (given out of order)
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 16-OCT-2007 the patient was inoculated with ZOSTAVAX vaccine at a medical center for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 22-JUNE-2010 the patient was treated at a medical center for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir and azithromycin for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Has 1/2 cm raised area where GARDASIL vaccine was given on 5-13-08.  Extreme itching still.
He got his vaccine in the morning, that evening he started noticing while he was watching TV that there were dark shades/spots on the TV.  He covered his left eye and everything was fine, and covering the right eye he had 20% vision left.  He can see spots in the right eye.  The next morning he went to an optomatrist who saw him and told him to go to an Ophthalmologist and Dr. did a lot of testing and told him that he had nonicteric ischemic optic neuropathy.  He was told to come back in a month to see if the swelling had come down, was told it was basically an eye stroke.  He informed him that 99% sure that it was irreversible.  He went back a month later and the swelling was better, the damage was permanent and that he had a 20% chance that it could travel to the other eye in 10 years.  He went to him again for 2 more times, and then moved to another location.  He then saw another Dr. (oculoplastic surgery).  He confirmed the diagnosis and went to him for a 2nd opinion to see if anything could be done, any type of surgery and was told that nothing else could be done, not even a medication or any form of treatment.  Since seeing the doctors his eyesight has not gotten worse, not gone into his left eye, and his right eye has 90% vision block.  He cannot read out of his right eye or use a computer or see anything legible.    He has had no trauma, no illnesses and everything is always good.  He was in relatively good health, had the vaccine and now is afraid to get anymore vaccines.  No prior issues with his vision.
The morning following administration, patient developed hives, which progressively worsened over 16 hours.  Treated in the ER with IV steroid, antihistamine and H2 blocker.  Now on oral steroid, antihistamine and H2 blocker with symptoms that come and go.  No oral mucosal involvement or joint pains.
Congested; voice is different; severe headache; weak; Asthma; Chills; This is the spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 formulation: solution for injection, Lot Number: EW0177; Expiration Date: 31Aug2021) via an unspecified route of administration in arm left on 21May2021 (age at the time of the vaccination 64 year) as dose 2, single for COVID-19 immunization. Medical history included Severe allergies (diagnosed many years ago), asthma (diagnosed in her 20's), blood pressure high (diagnosed 15 years ago), high cholesterol (diagnosed many years ago), PTSD with depression (diagnosed 16 years ago) and PTSD with depression. The patient taking Pfizer BioNTech COVID vaccine to get protection from the corona virus. Concomitant medications included loratadine (CLARITIN [LORATADINE]) for allergy and montelukast sodium (SINGULAIR) for allergy. The patient historical vaccine included received first dose of bnt162b2 formulation: solution for injection, Lot Number: EW0167; Expiration Date: 31Aug2021) via an unspecified route of administration on 30Apr2021 (age at the time of the vaccination 64 year) as dose 1, single for COVID-19 immunization. The caller was concerned about her severe allergic reaction that she was having from the vaccine. On 21May2021, the patient experienced severe headache, weak, asthma and chills. On 23May2021, the patient voice was different. On an unspecified date, the patient was very congested maybe, she was unsure how to explain it. The patient used her inhaler she felt better. The outcome of the events severe headache, weak, voice was different and chills was not recovered. The outcome of the event asthma was recovering while outcome of the event congested was unknown.  Follow-up attempts are completed. No further information is expected.
When I received the vaccine after the first 2,3 hours I started to feel a lot of chest pain as well as spasms on the side of my heart area, and it was difficult to breath and heart agitation. I called 911 and they told me to stay calm and if the effects continued, I should go to a medical center. In my hometown for about more than 1 month and a half my chest hurt a lot, having aggressive and continuous spasms. I went to the doctor and he said not to get the second dose since it could be a possible effect of myocarditis.
Right arm with 10x12cm redness, warmth and swelling over deltoid. Axilla red with 1.5cm x 1.5 cm node palpable. Pink/blush up whole Right side of neck. No significant pain to palpation.
Feet swelling, legs throbbing, when I wake up in the morning I cannot walk I run into walls fall backwards, fall down, my feet hurt so bad I can feel every bone in my feet in pain. They sometimes tingle and go numb.
I have a red rash around the injection site.  It is not bothersome, so I have not treated it.
Onset of heat, redness within 30 minutes of injection into left deltoid. The site began to swell and itch within an hour and continues to have redness, itching and swelling at the site. Firm to touch. No drainage noted. Has applied cold compresses and took some Benadryl at night to decrease the itching.
This spontaneous report as received from a physician refers to a child patient of unknown age and gender. On an unknown date the child patient was inadvertently administered a dose of ZOSTAVAX (lot#, dose, route, indication not reported) instead of VARIVAX (Merck). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Had fever 101 (R) @ bedtime on 7Feb91 (day that DPT was given)-Fever 105 (R) next morning.Episodes of vomiting (twice) very fussy-Fever lasted<48 hrs-off & on.Was seen by MD 8Feb91.DX-Fever 2nd to DPT cont APAP/observe. Full recovery.
Psoriatic arthritis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   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) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unknown date, patient received COVID-19 Vaccine manufactured by Moderna, lot number unknown. 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. No treatment medication was provided.  Company comment  This spontaneous case reported by a consumer, concerns an elderly female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that on an unknown date, patient also took Adalimumab for Rheumatoid Arthritis, which could be considered as a confounder for the event. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an elderly female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that on an unknown date, patient also took Adalimumab for Rheumatoid Arthritis, which could be considered as a confounder for the event. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Case number PHEH2016US026739, is an initial spontaneous report received from a consumer on 13 Oct 2016. This report refers to a 41 years old female patient. Medical history and concomitant medications were not reported. Current conditions included allergies to sulfa, cipro and amoxicillin. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 162001) at a dose of 0.5 ml intramuscularly on 13 Oct 2016. On the same day 2 hours after vaccination, the patient passed out for 10 minutes. It was reported that, she also felt clammy and nauseous when it happened. The outcome of the event passed out was unknown and of other events was not reported. The seriousness of the event passed out was reported as non serious by the consumer and of other events was not reported. The causality of the events was not reported. The seriousness assessment of the event loss of consciousness was upgraded to medically significant based on the Novartis Important Medical Event list.
started fever the evening after receiving the shot. By 3:00 am had body aches. 5:30 am fever over 101, nearly fainted.  Fever lasted about 24 hours, low grade fever continued about 5 more days. Fatigue, body aches also. Controlled symptoms with ibuprofen.
At 5:00 AM I woke up and walked to the kitchen to take some Tylenol for my headache. I started feeling dizzy, hot and lightheaded, so I went and sat down. I don't remember, but I must've tried walking back to bed and fainted while walking.   I was dizzy after the second dose also for several hours, but never actually fainted.
Severe headache upon waking. Not able to be relieved by any pain medications. Headache has continued through mid day 9/28 with no relief by pain medications.
I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was feeling extremely depressed again, teary and sad and not sure why; Very very tired; Unmotivated; I was feeling extremely depressed again, teary and sad and not sure why; excruciatingly painful; This is a spontaneous report from a contactable consumer. A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EWC158) via an unspecified route of administration, administered in arm right on 15Apr2021 at 07:45 (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP6955) in left arm on 25Mar2021 at 12 pm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID post vaccination. There were no known allergies. There was no prior COVID vaccination. I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021, but it was incredibly heavy and excruciatingly painful, I was also much more sad, depressed, exhausted than normal. The feelings of depression were extremely overwhelming. This week (24May2021) I was feeling extremely depressed again, teary and sad and not sure why, very very tired and unmotivated, started my period again only 12 days later 27May2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information was expected.
About 5 minutes after receiving the vaccine, patient felt dizzy and fainted but quickly regained consciousness. We had him lay flat on the floor and continued to monitor and have conversations with him. His vitals were confirmed to be normal by the EMS and patient declined to be transported to the hospital. He remained in the premises for about an hour for observation after which he had a friend drive him home.
The Moderna vaccine with lot # 003C21A that was sent out on 11/24/21 to your clinic should have the absolute expiration date of 12/17/21 and not 12/24/2021.
hosp 13NOV & 14NOV w/dx idiopathic thrombocytopenia purpura-given IGIV;pt followed @ cancer & blood disorder clinic;recv IGIV again 1DEC97;
After 3 minutes of administering the vaccine, patient c/o feeling hot and sweating. It looks like she is experiencing vasovagal syncope. She was able to communicate. She was given ice pack to place on her forehead. When ask if she has eaten or drink anything today. She response no. She was given water and 1 Lindor Chocolate . She felt better. She was able to text her husband to let him know what's going on. She drank a total of 1 and 1/2 bottle of water ( about 20 oz) . She was instructed to sit on the chair the entire time. After 30 minutes , she was able to stand up and walk to her car no problem. Her  husband drove her home. We talked to her about 3 hour later and she reported of doing  fine.
Shortness of breath, swollen tongue, smooth spots on tongue. These symptoms lasted 24 hours.  7 days after vaccination I had a 5" rash at injection site.
Child developed a large local reaction around the injection site of 10 cm. Area is warm but non-tender. Child is afebrile. Was started on Cefzil 125 po bid x 10 days.
pain in (R) arm at inj site. redness, warmth, temp 100 deg. SEPTRA given for possible cellulitis. TYLENOL/MOTRIN for discomfort, apply cool compresses to site. Refer to V.I.S given at time of admin. of vaccine
Itching on his abdomen and ankle; Rash on his abdomen and ankle; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on his abdomen and ankle) and RASH (Rash on his abdomen and ankle) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Itching on his abdomen and ankle) and RASH (Rash on his abdomen and ankle). On 29-Jan-2021, PRURITUS (Itching on his abdomen and ankle) and RASH (Rash on his abdomen and ankle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
believes it has a little fever; Got the first shot, there was a little soreness; Redness at the injection site for about 4-5 days; The rash is back/ Injection site rash is getting bigger; little itchy/ Itchy with a lump in it; Itchy with a lump in it; Little swollen at the injections site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) intramuscular on the left arm from 07Jan2021 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported that she got the first shot and noticed redness at the injection site for about 4-5 days in Jan2021 and then it went away. Reported that 2-3 days ago she noticed that the rash was back or the redness at the injection site was back and itchy with a lump in it. She reported that the spot was 2 inches in diameter then went to 3 inches, so it was enlarged. She was asking "should I put something on it?" and "the next shot is on the 28th, should I get it?". She got the first shot on 07Jan2021, there was a little soreness. It took it from then until Monday for the redness to go away at the injection site and it did go away but then last night she was putting on lotion and she looked on the arm there it was back again there was a 2 inch red circle and it looks like it has little rash type thing in it and it was itchy. She had a redness and it looked little swollen at the injections site (Jan2021). She noticed the injection site rash was getting bigger, referring to the little rash around the site, and it was a little itchy and she believed it has a little fever. Added it was 2 inches and now it was 3 inches. Outcome of the events vaccination site pain and vaccination site warmth was unknown, while not recovered for the other events.
Patient was scheduled today (12/17/21) to receive his second dose of the Pfizer (12+) vaccine. Patient is 13 years old. Patient was inadvertently given the Pfizer (5-11) vaccine instead of the intended vaccine.  Patient's parents were notified via phone. Current CDC recommendations state that an additional dose is generally not advised.