chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is a 61 yo female with recurrent granulosa cell tumor (s/p secondary debulking/whipple in 2019), stage II colon cancer, and stage IA cancer s/p radiation on tamoxifen/megage, with history of short gut on chronic TPN. On admission (5/4) she presented with weakness, diarrhea, and fever. Pt was tachypnic to 40s, 1L NC with O2 sat > 90% on admission. RR improved and she was eventually weaned to room air. The COVID PCR on admission resulted positive. She is s/p full Pfizer vaccination: first dose on 2/25 and second dose on 3/18. Pt remained stable on room air for the rest of her stay and received remdesivir for 5 total days.
9.5 x 6.25 cm firm, non tender erythematous raised hive like lesion, blanching right deltoid.
Swelling eyes and lips, and all over the body. And can walk.  And it come and go.  On this day is starting.
per verbal report, pt given vax 4JAN96 & p/arriving home pt napped & woke up very lethargic & pale;taken to acute care ctr-pulse ox 85-90 started on 02 + transported to hosp;MD @ ER notifies hlth dept 5JAN96 & dx sz r/t immun
pt recvd vax & immed p/inject exp SOB, tremor & shaking; hyperventilation, cramping & weakness of the legs, & chills;
Vivid, strange dreams noted on nights 1 and 2 post vaccine. Soreness noted at injection site 2 days post vaccine. On 3/14, woke with arm pain from shoulder to fingertip, some radiating numbness, and shooting pain. The pain was not unlike hitting the funny bone, but was in the shoulder to the fingertips. At times, using the arm was difficult and made me question the potential of it being a heart attack or other cardiac event.  Injection site was red, feverish,  hard, and tender. Area felt bruised. Red area was about 2-3" high and 4-5" wide. Arm pain subsided 3/15, but redness/swelling/feverish/tender site lasted until 3/20. The same area that was red and feverish became discolored and slightly grayer/pinker than surrounding skin on 3/20 and persists (as of now 4/3/21)
Visual disturbance; Weight gain; Blood sugar increased; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (Visual disturbance), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1F890A) for COVID-19 vaccination.     No Medical History information was reported.    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 VISUAL IMPAIRMENT (Visual disturbance), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased). At the time of the report, VISUAL IMPAIRMENT (Visual disturbance), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased) outcome was unknown.            No concomitant medication was reported . No treatment medication was reported.
On 1/9/2013 employee developed swollen, red and hot to touch area the size of a tennis ball around injection site. Arm is sore to touch and muscle is sore when she move it. Pt taking ALEVE & using moist heat.
p/vax pt devel diarrhea described as an excessive amount (up to 12/day) of yellow-green, runny, stringy & watery stools which persisted for several weeks;MD stated mom tried constipating pt by feeding rice cereal & bananas w/o relief;
Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few seconds of swallowing.
My symptoms came on very suddenly around 5:30 in the afternoon - I?ve described it like getting his by a truck. My symptoms include intense full body aches, moderate fever, chills/sweats, headache, and fatigue. It has now been 23-hours since my vaccine was administered and my symptoms have now subsided.
Pt rec'd IPV, PCV and DTaP two days ago. Rash on face, papular erythematous next day. Fading but progress on trunk and back. No fevers.
Patient was at the Trouble Shooting for Health Mobile Site for immunizations only. Patient moved here with an Immunization Record and verbalize not having access to a record. Mother wants to start over with immunizations after explanation of 7 shots. Consent for immunization was completed by mother. Vaccine information sheet(s) were provided to mother in different languages: Patient was screened for contraindications, and had no true contraindications. Hep B IM, Influenza A and B (Seasonal) IM, IPV IM, MCV-4 IM, MMR subcutaneous, Tdap (adol/adult formulation) IM and varicella subcutaneous given. 1325 After given Tdap, IPV, FLU and varicella pt started sinking in his chair, jerky body movements, pale, and sweaty. Patient was secured in the chair not to fall and feet elevated. Patient complained of dizziness. Patient denied nausea, SOB itching, difficulty swallowing, headache, chest pain and stomach ache. Assisted patient to lie down in Trendelenburg position. Vitals BP 159/89 HR 86, Resp 22 Temp 98.5 orally. 1326 Dr notified of patients conditioned and approves to give the other immunizations with the mothers consent. Patient skin pink, warm and dry to touch, denies pain, dizziness at this time. Mother consent to continue to vaccinating. 1330 Hep B, MCV-4 and MMR was given and tolerated well. 1335 patient sitting and denies complaints of pain, dizziness, nausea, headache, SOB, chest pain, itching difficulty swallowing, blurry vision and stomach ache. Patient alert O x 3, skin warm and dry to touch, skin color pink, respirations are even and unlabored, able to move all extremities. Lungs are clear in all 4 lobes, throat without swelling or redness noted. 1345 Dismissed home with mother ambulating in stable condition. ER precautions given and mother verbalize good understanding of instructions given. Explained to mother to follow-up with PCP for further episodes of syncope. Care instructions translated by PCS.
Janssen COVID-19 Vaccine EUA  Body rash covering torso and leg appeared morning of 4/12, subsided roughly 12-14 hours later. Also had mild fever first night (4/11) after injection; persisted 4/12 and had completely subsided by morning of 4/13.
Soreness of arm; Collapsed completely; feeling so dizzy that she went to sleep; Noose down; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), FEELING ABNORMAL (Collapsed completely), DIZZINESS (feeling so dizzy that she went to sleep) and DEPRESSED MOOD (Noose down) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm), FEELING ABNORMAL (Collapsed completely), DIZZINESS (feeling so dizzy that she went to sleep) and DEPRESSED MOOD (Noose down). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), FEELING ABNORMAL (Collapsed completely), DIZZINESS (feeling so dizzy that she went to sleep) and DEPRESSED MOOD (Noose down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-JUN-2021, contains no new information.
CHILLS; LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced chills, low grade fever, and mild headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, low grade fever, and mild headache. This report was non-serious.
Tightness in chest, throat, hives, soreness in left arm, felt unwell for four days.
Pt received her first dose at a clinic other than ours & was under the age of 18.   We did go ahead and gave her her 2nd dose so she could be fully vaccinated.  She will be 18 in less than a month. 1st vaccine received at heath dept.
Please note, I was counseling pt on a separate medication, but she mentioned to me that she had a "Covid booster" and that sometime after her booster she developed a rash. She described it as "not hives," but a skin condition. I don't know when she had the booster or which manufacturer it was. I don't know when her symptoms started, but she seemed to indicate soon after. She said she doesn't know if this skin condition was a result of the vaccination or not. She has been treated with Xolair though due to diagnosis of idiopathic urticaria. I also did not advise pt I was going to report this AE as I wasn't aware at the time this was something we are obligated to do at my workplace (even if we didn't administer the vaccine)
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX (lot # and route not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct and proximate result, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result the patient sustained severe and permanent personal injuries. Further as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, anguish, emotional distress, loss of enjoyment of life, physical impairment in injury. Shingles and vaccination failure were reported to be disabling. Additional information has been requested.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received KINRIX (batch number 23MJ7, expiry date 22nd October 2015). Previously administered products included PEDIARIX and PENTACEL. In September 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
1st shot, felt nausea, headache, sore arm for a day, sore arm lasted 5 days.  2nd shot, Chills, bad headache, hard to breath, diarrhea, nausea, very sore arm, high heart rate. 1 1/2 days.   Today is 8/21/21 and I still have diarrhea,  hard to breath at night and sore arm.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting,  fatigue
Information has been received from a physician concerning a 17 year old female with unknown allergies who 11-JUL-2008 was vaccinated with a first dose of GARDASIL (lot# not reported). Within "24 to 36 hours," the mother of the patient called, because the patient developed rashes on her tongue and on her forearm. The patient was seen by a physician. No further information was available. Additional information has been requested.
pt recv vax & several days later pt exp rash (10 lesions);no further details were provided;
This spontaneous report was received from a licensed practical nurse referring to a 20 year old non pregnant female patient. The patient did not have pertinent medical history, drug reactions, allergies and concomitant medications. On 01-MAY-2001, the patient was vaccinated with her first dose of VARIVAX followed by her second dose on 02-DEC-2009 which was reconstituted with sterile diluent (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) indicated for varicella prevention. The patient's titers of VARIVAX was performed on 31-JUL-2018 as a school requirement, which showed that she was "low positive" for varicella titers, described as "108.4(units not reported), with a reference range of greater than 164 (units not reported) for normal positive results" (viral titre decreased). The patient sought medical attention by reviewing the results with her physician and no treatment was given for the adverse events. The outcome of viral titre decreased was reported as not resolved. The reporter did not assess the causal relationship between viral titre decreased with VARIVAX.
Extreme Vertigo  requiring medical attention. Sissy ness and nausea lasting 24hours..
Vaccine was opened on 04/10/23 at 11:00 am and only viable for 12 hours after puncture (11pm). The vaccine was clearly labeled that it expires on "04/10". On 04/11/23 at 1359 the vaccine was drawn up and administered to patient.
Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (12mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
The day after I received the shot I felt totally run down and then had severe chills. I received the the Vaccine on Wednesday and on Friday night I was running a fever of 102.5. By Saturday morning I am feeling much better but the chills, body aches and fever really knocked me down.
After the injection roughly 2 minutes  I got light headed and passed out.  I was woke up by the nurses after being unresponsive for approx 30-40 seconds.   My blood pressure was around 100/40, and my pulse was around 36.   The numbers may be off a bit but I was still waking up and can't remember the exact numbers.  The numbers should be wrote down by the nursing staff and filed.  They watched me for 30 minutes and let me go.   Today on 8/26/2021 my stomach hurts and I have pressure in my chest.   I think I'm just constipated so I am trying to take care of that.  If it doesn't work and I still feel this way after I pass a stool, I will go to a hospital.  To be safe.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment details are not provided.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter stated that "Had Omicron in January. Weekend, Saturday-Sunday. Very mild, no fever. Only stayed in because of infectiousness. Blessed. Thanks to God, vaccine and Booster Shots, Janssen, Hearing now re deltacron, covid deltacron hard hit. Masks work this summer, you watch" which was coded as suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. The patient received additionally covid-19 vaccine ad26. cov2.s (dose number in series 2) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000222694.; Sender's Comments: V0:20220342357-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX, the patient experienced crawling sensation. On an unknown date, the patient experienced tingling sensation, erythema and swelling. On an unknown date, the outcome of the tingling sensation and crawling sensation were recovering/resolving and the outcome of the erythema and swelling were recovered/resolved. It was unknown if the reporter considered the tingling sensation, erythema, crawling sensation and swelling to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she experienced minimal swelling and slight redness after receiving SHINGRIX and 1 week after receiving SHINGRIX, she felt like something was crawling on her from the top of her left shoulder, across her collar bone, to her chin. At the time she felt it all the time but she said it had gotten milder but she still experiences it and sometimes it occurs 2 to 3 times a day. The patient did not have information on the vaccine that was administered to her.
Developed acute hypoxic respiratory failure, severe sepsis secondary to COVID-19 pneumonia.  Required mechanical ventilation. Despite treatment, she continued to decline and expired 11/26/2021.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored GARDASIL (lot # K011562, expiration date 08-APR-2017; lot # K016966, expiration date 10-MAY-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed itchy, red spot approx 2-3 inches in diameter at injection site; symptoms consistent with "covid-arm". Itch retreated after about a day, still red  but also retreating around injection site. No treatment necessary. Checked visually at primary care facility and released
States R was swollen & red from inject site to wrist x 2 days; c/o pain & red @ site unil yest; Arms warm to touch & knot still on lt arm;
After receiving the DTap shot, patient developed a red patch about the size of a softball on his arm in a ring around the injection site.  It was red and warm to the touch.  No fever or itching or significant pain was reported by 5yr old.  Still red but seems to be fading as of 5/29/10, 3 days after shot. Seen by Dr. on 5/28/10 who said it was a "localized reaction" and not to worry unless it got worse.
Itching of neck, face, head, and some itching of trunk and arms.  24+ hours after dose, itching of the face/neck has continued, and increased around the 24 hour mark.  Took over the counter benadryl for the itching and motrin for other expected/listed side effects (sore throat, headache, chills)
Immediately developed fever, uncontrollable crying and diarrhea.  Contacted doctor and was instructed to give tylenol and liquids.  Over next several months, speech delayed, lost eye contact, recognition of family, did not want to be held, appeared not to hear, started stimming, toe walking, obsession with lights, and hyperactivity.  Was tested at pediatrician's recommendation for lead poisoning (negative).  Several developmental delays.  Later diagnosed with pervasive development disorder and finally aspergers syndrome in 2004.  We are so late in filing this report because we did not even known this report existed.
Client c/o light headed feeling immediately after receiving vaccine.  Client denies any other symptoms.  Client seen and assessed by EMT and assessments are: BP 173/78, HR 94, O2 96%,  Client verbalized a decrease in symptom and cleared to go home by EMT.  Client advised to seek medical attention if symptoms worsened and she verbalized understanding.
I had a very heavy period starting on the 6th and it was clotting, it was overly heavy. That continued about a week and stayed heavy. I also started getting hot flashes every five minutes and those would come and go all day long. I was dripping all day long. Those lasted a week about a week too and then they were done and I haven't had any more. I had a full physical before I took a trip and I told my doctor about these symptoms. I didn't have another period until May 26th  which was a normal one and on that same day, my breasts swelled super big. Almost double the size. On the 27th of May, I went to the doctor. He ordered a mammogram and an ultrasound. That was on the June 2nd. I had those done at the hospital They found huge cysts, one was five inches long, on my breasts, (both) full of them all of a sudden. About a week later, those cysts went away and everything was fine. My breasts went down to normal size.