chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient noted on form that he had a severe reaction to peanuts which causes him to have anaphylaxis.  He stated that he does carry an EpiPen and any time anything with peanuts touches his mouth/lips he immediately notices his throat starting to close.  He also is allergic to cats.  Before administering the vaccine, the patient noted that he does not like needles and was not going to look.  I administered the vaccine and the patient and I exited the vaccination room.  I explained that he should sit in the waiting area for about 30 minutes due to his severe allergic reaction in the past.  By the time that I walked back into the pharmacy, the patient's wife shouted "He's not breathing!".  My technicians called 911 while I grabbed an EpiPen and rushed to the patient.  I immediately administered a 0.3 mg dose of epinephrine and observed that the patient had passed out, was not breathing, but had a pulse.  A few seconds later he regained consciousness and his breathing was erratic.  I gave him water and he stated that he felt very lightheaded and dizzy.  I instructed him to remain seated.  He also noted that his vision was blurry and he saw a black dot.  His wife was fanning him to cool him down while I tried to obtain the patient's blood pressure, but could not get a reading.  The paramedics came and evaluated him thoroughly.  His blood pressure, heart rate, EKG, and blood sugar were all within normal limits.  They determined that the syncope was most likely due to the patient not eating during the day and not liking needles.  The patient was feeling much better and declined further medical treatment, including going to the hospital.  He was instructed to go home and relax.
Swelling and redness around injection areea.  The following day bright red, swelling and severe burning and stinging from shoulder to elbow and low grade fever.  Took antihistamines and Aleve for the pain for three days.
That night a headache , next day same headache with slight aches and pains fatigue , next morning 0400  exhaustion , lightheaded , dizziness , confusion , and fainting .
administered the Shingrix second dose with less than the recommended time; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date 14th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended time interval, which led to shortening of vaccination schedule. The health care provider asked for scheduled time for Shingrix to decide how to proceed with 2nd dose. The reporter consented to follow up. This case has been linked with US2021094192, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094192:same reporter
Pfizer on 3/9 and 3/30. Positive on 8/6 8/5-8/13 admitted
received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-273004 (Patient Link).
Headache, Arthralgia, low back pain, arm pain, brain fog Narrative:  Pt reported low back pain, arthragia, headache, arm, brain fog on day after given covid vaccine. Pt self treated with ibuprofen 400mg.
Had very sore arm with some swelling. The nausea, headaches, extra fatigue, some heart racing, etc Overall unwell feeling has lasted. some parts of a day can get better.I feel much like I went backwards with lyme disease-
. One minute im freezing the next im hot, I can't breath out my nose and now my body feel like I got rash that irritated all over and feel like im about to throw up. Arm stiffness
Around 12 hours after receiving the second dose of my Pfizer vaccine, I came down with a fever and a headache, which prevented me from getting to sleep. The fever and headache abated by the early afternoon, but drowsiness persisted until the following morning.
Extreme pain and peripheral neuropathy in both hands, feet , and arms.  Muscle/joint aches, fever.
left side cheek swelling; feeling nasty; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left side cheek swelling) and FEELING ABNORMAL (feeling nasty) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Pfizer primary vaccine series) and PFIZER BIONTECH COVID-19 VACCINE (Pfizer first booster). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (in spring).    On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced SWELLING FACE (left side cheek swelling) and FEELING ABNORMAL (feeling nasty). In April 2022, FEELING ABNORMAL (feeling nasty) had resolved. At the time of the report, SWELLING FACE (left side cheek swelling) outcome was unknown.            No pre-existing condition was reported. No concomitant medication was reported.     Few days after getting second Moderna booster patient felt nasty which went away and then has developed cheek swelling on his left side of the face.  No treatment information was reported.
tested positive for covid, vaccinated with 2 doses by summer 2021; tested positive for covid, vaccinated with 2 doses by summer 2021; This is a spontaneous report received from a contactable reporter Consumer.  An adult female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There were no other vaccines received in four weeks. The patient did not have Covid-19 prior vaccination and the patient previously tested multiple times on multiple dates post-vaccination with negative results. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome unknown. The event tested positive for covid, vaccinated with 2 doses by summer 2021 was evaluated at the emergency room visit. Clinical course reported that the patient was showing covid symptoms as of yesterday morning in Dec2021. First indicated that the patient did not feel well at around 11:45 am. The patient has had sore throat, cough, headache, congestion/runny nose, and fatigue. Said felt funky. Still has taste. Seemed to improve over the course of the day (started with what seemed like a lot of coughing and that lessened). Took Tylenol at around 3:20 pm. The patient was present at an engagement party on Sunday, where it has been reported at least 3 people have tested positive for covid that were in attendance. As of this morning (23Dec2021), the patient is now running a fever in addition to the other symptoms. The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Dec2021) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Injection Site - Erythematous, induration; No fever; No itching; No pain
Child develop symptoms the following day after the vaccines were given. Child developed vomiting ×3, face was flushed and developed hives. Mother treated symptoms with Benadryl. Child was then seen in the emergency room at Hospital. He was asymptomatic on arrival to the hospital. He was treated with prednisolone and Pepcid.
grandma reports sz & low grade fever @ 1AM 17MAR94 & pt was then admitted the local hosp where fever was 102; 2 more sz followed @ 8AM & another later in the day; pt was transferred by airplane to hosp;
Local reaction, redness, swelling hardness at injection site left arm started Sat seen in ER then we saw pt on Mon (Inj. given Thurs).
Hypothermia; Cold sweats; No appetite; Some dizziness; Temperature 94.2; Dull headache; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothermia, cold sweat, appetite lost/decreased appetite, dizziness, temperature body decreased/body temperature decreased and headache   The patient's medical history was not provided by the reporter. No concomitant medications were reported.   On 12 Feb 2021, about two weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After two weeks on 26 Feb 2021, the patient developed hypothermia in the morning. Then patient experienced a drop in body temperature to 94.2 F. The patient had to change clothes frequently due to cold sweats. The patient also reported that she had headache, dizziness and no appetite.  The treatment medication was reported as acetylsalicylic acid for headache.  The event hypothermia was considered medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, hypothermia, dropping body temperature, cold sweats, headache, dizziness and no appetite were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
12/30/2020 nursing staff noted fine sl. rash on trunk and lower abdomen. He c/o itching and physician notified. Orders were received to monitor.  12/31/2020 red rash persist, pt. denied much itching. Did report he has a hx. of rashes and "uncertain as to cause". Denied any diff. with breathing.
Initial report received on 28 April 2009 from a consumer. A female patient (demographics not reported) had received on 16 June 2008 a dose of Hep B vaccine (trade name, manufacturer name, lot number, route and site of administration not reported). Seventeen days later, on 03 July 2008, the patient received a dose of IMOVAX RABIES (lot number A0484, Sanofi Pasteur SA lot number A0484-2). At an unspecified amount of time after receiving both vaccines, the patient began experiencing fatigue and now states she has "MS" (Multiple Sclerosis). Treatment received, diagnostic tests and laboratory data performed were not reported. It was not reported whether the patient required hospitalization. The patient has not recovered. Documents held by sender: None.
PATIENT REPORTS BEING IN A PARKING LOT 2.5 HOURS AFTER RECEIVING VACCINE AND BLACKING OUT AND WHEN SHE CAME TO, SHE WAS IN THE HOSPITAL AFTER HAVING TO HAVE CHEST COMPRESSIONS FOR 30 MINUTES TO BRING HER BACK.  AFTER HOSPITAL EVALUATION, THE ONLY THING THE HOSPITAL COULD ATTRIBUTE HER EPISODE TO WAS THE VACCINE AS NOTHING ELSE SHOWED ON LAB WORK AND EXAMINATION AND PATIENT DID NOTHING ELSE DIFFERENTLY.
Took Advil going to sleep, woke up at 4:30am, real dizzy: unsteady walking to & from bathroom, walked into the wall.  Dizziness was bad all morning  & continued on & off all day. 1/20/21 - woke up dizzy again, but not as bad.  Remained light headed all day.  1/21/21? lightheaded not as continuous.  Finally feel fine in pm.
30SEP96 mom brought pt to hlth dept & reported that pt had a sz the noc of vax;pt taken to ER & dx was probable febrile seizure post vax;instructed to have pt checked by pvt MD in AM-did not have checked by pvt MD as advised;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On about 14-AUG-2007, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On about 16-NOV-2010, the patient was treated by the same physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Extreme fatigue, soreness at injection site. Muscle stiffness, headache and  body aches.
The patient experienced a metallic taste shortly after vaccination. The patient then experienced a severe headache and nausea about 13 hours after vaccination .
swelling at the injection site; redness at the injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (itching at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20) for COVID-19 vaccination.     Concurrent medical conditions included Vaccination site swelling on 23-Jan-2021, Vaccination site erythema on 23-Jan-2021 and Vaccination site swelling on 23-Jan-2021.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (itching at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (itching at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-020032 (Patient Link).   Reporter did not allow further contact
Given IPOL instead of VARIVAX. Patient also received a dose of PEDIARIX at same time.
Treated in the emergency department on 12/03/21 with chest pain.  Patient presented with 1 week of "dull" chest pain and 30 minutes of sharp mid-sternal pain.  Nausea and vomiting began after arrival to ED.  No prior cardiac history.  Physician diagnosis of myocardial infarction acute, cardiac arrest.  Patient expired on 12/03/21.
Headache, Fever, NauseaVomiting,  fatigue  Narrative:
Irregular Menstruation. First period was late. The following months they have been very irregular. Some very long, some shorter. In September my period did not stop until after my October period ended. In other words I bled from Sept 10 to Oct 7.
24 hrs no effect - Fri woke at 4 am for work - arm, shot location, red; hot to touch slightly raised, swollen, hands cold, slight fever -itchy.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In November 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# and dose were not reported). On 01-MAY-2015 (reported as "three weeks ago") the patient went to unidentified physician that she developed shingles that affected her eye area "with lesions along with pain, discomfort, at which point unidentified physician prescribed NEURONTIN and also prescribed acetaminophen, PERCOCET for pain. The outcome of the event was not reported. Relatedness between therapy and adverse event was not provided. Additional information has been requested.
Rash, shortness of breath.  Rx- BENADRYL 25mg IV, SOLUMEDROL 125mg IV;  MEDROL DOSC Pack, BENADRYL PO- Symptoms resolved.
"A mother reported that her 2 month old son, post vax, experienced several episodes of vomiting and constipation. On 7/17/99, the infant became irritable."
Cannot eat much of anything; A little bit of pain at the injection site; Been vomiting from time to time; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Cannot eat much of anything), VACCINATION SITE PAIN (A little bit of pain at the injection site), VOMITING (Been vomiting from time to time) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METFORMIN, GLIPIZIDE and EZETIMIBE (ZETIA) for an unknown indication.    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 FEEDING DISORDER (Cannot eat much of anything), VACCINATION SITE PAIN (A little bit of pain at the injection site), VOMITING (Been vomiting from time to time) and NAUSEA (Nausea). At the time of the report, FEEDING DISORDER (Cannot eat much of anything), VACCINATION SITE PAIN (A little bit of pain at the injection site), VOMITING (Been vomiting from time to time) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  Concomitant medications included High blood pressure medications. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Additional information was received on 25 Mar 2021: added patient initials, age and gender of the patient.
Immediately after receiving Rotateq PO, infant vomited up formula (Mom said was fed about 1/2 to 45 minutes prior to immun.)
Information has been received from a registered nurse concerning a patient who in approximately April 2008 ("in the past few weeks"), was vaccinated orally with a 2 ml dose of Rotateq.  In approximately April 2008, within one week of vaccination, the patient had blood in their stools.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Upon internal review "blood in their stools" is considered an other medically important event (OME).  This is one of two reports received from the same source.  Additional information has been requested.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored GARDASIL. Strength, dose, route and lot number were not provided. GARDASIL was exposed to a temperature between 46.5F and a highest of 48F for a total 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004215, 1405USA004216 and 1405USA002823). Additional information has been requested.
Moderna COVID-19 Vaccine EUA The evening after the vaccine I had mild soreness in the arm with the injection site. The next morning i woke up with a severe headache, total body muscle aches, chills, mild nausea. I slept most of the day. Symptoms continued all day but were gone by the next morning. (vaccine on Saturday, adverse reactions all day Sunday, total recovery to normalcy on Monday with sometiredness.
The pt had a severe headache, fever, and dizziness. The pt was given Motrin.
Headache, metallic taste, nausea. BP 156/81 (pulse 59). Final BP 160/76 (pulse 52). Sent to ED, but left upon arrival, as she felt OK.
pt recvd vax;had t of 105 per mom,noc of vax;returned to clinic 13jan95 for exam;
Pain, redness, swelling at injection site within 24 hours of administration--patient has not experienced such a reaction beforfe
pt had a positive COVID test on 2/8/22 at Medical Center; pt passed away at home; no record of PCP
Lymph node swelling and pain in left armpit and left side.   Tender to the touch.  This was the side of the injection.  Lasted for a week after the vaccine injection.
Syncope and falls (loss of control of muscles, flaccid) secondary to orthostatic hypotension never experienced before in patient?s life.
Patient was given the GARDASIL shot at county health dept.  She had two other shots done in her right arm, before the GARDASIL shot was given on the left side.  Patient immediately fainted.  When the nurse and I got her back up onto the table, she seized  for about 30-60 seconds.  It scared the nurse and I both.  When she finally "came to" she was extremely disoriented.  She said that her legs felt really "heavy"  and that her head hurt.  It took her about 30 minutes to be able to just stand up.  She was then really tired and exhausted all day the rest of that day.   This really scared both of us.  She really doesn't want to take the next 2 series of the shots because she is scared to death the same thing will happen again.  Frankly, so am I.  Is this going to be a possibility? Or do we not take the shots now?  Please let us know as we are both really concerned.