chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; chills; headache; fatigue; hot flushes; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue) and HOT FLUSH (hot flushes) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), HOT FLUSH (hot flushes) and PAIN (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), HOT FLUSH (hot flushes) and PAIN (body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non significant follow up received on 26-APR-2021, no new information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, chills and fatigue are consistent with the product safety profile.
pt recvd vax; pt devel t 102 & had light pitched cry for 20 min; pt was shaking described as lethargic by mom, "just stay there & stare"; mom also reports inject site LL was hardened after a white ctr like a pimple; pt had bruise on R hand;
received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's Comments: The reporter stated that a patient accidently received an expired Havrix vaccine. The patient received a dose on 20th June 2022 when the expiration date of the vaccine was on 18th June 2022 The reporter did not consent to follow-up. Additional Supportive Information: The patient received Havrix which was already expired in 18th June 2022, which led to expired vaccine used.
I received the J&J vaccine on 04-29-2021.  On 06-09-2021, I tested positive for Covid.  I am experiencing headaches, lost of taste and smell, cough and shortness of breath. I continue with loss of taste and smell today and also have  slight headaches that come and go and my lungs feel much worse when taking in deep breaths. I feel like 5% better from my symptoms which started five days ago.
After the vaccine I felt more depressed than usual and still do now. It started same day or next day. I realize that I already have depression and it could be that. But I definitely feel "off" and I wanted to put it out there in case it helps you track things.
A consumer report has been received. The report concerns a 38 year old, female patient. No concomitant medication was reported. She had no allergy to eggs. On 25-Sep-2012, the patient received nasal FLUMIST. 10 minutes after taking FLUMIST, she passed out and had upper torso pain. On 28-Sep-2012, she also had off-balance and dizziness issues. The patient had an intolerance to monosodium glutamate. The outcome of the event of passed out, upper torso pain, off-balance, dizziness and MSG intolerance was unknown. Company physician assessed the serious criteria for the event of passed out as important medical event and considered the events of off-balance, dizziness and MSG intolerance to be non-serious. The reporter considered the event of upper torso pain to be non-serious.
Now have shingles.  Not necessarily an adverse event but am reporting as I have heard of several people getting shingles after the Moderna vaccine and just wanted to document my case for further study if necessary.
Patient's arm is red at injection site, and has swollen considerably from immediately around injection site down to just below his elbow. He also complained of a constant headache all day following administration. In addition, arm was warm to the touch, and painful to move.
Dtap ordered by Provider and given to 11 year old when patient should of received a Tdap.
shocks on the ribs; patient fell from the bed; broken rib; A spontaneous report was received from a consumer concerning a 96 years-old, male patient who experienced shocks on the ribs: paraesthesia.  The patient's medical history included a fall from bed on 31 Jan 2021 which resulted in broken left rib. Products known to have been used by the patient, within two weeks prior to the event, included dabigatran etexilate mesilate, furosemide sodium, cilostazol, levothyroxine, simvastatin, Tamsulosin, finasteride, and losartan.  The patient received their first of two planned doses of mRNA-1273 (Lot #013M20A) intramuscularly, in the left arm on 02 Feb 2021 for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient started to feel little shocks on the ribs on the right side. The reporter wanted to know if the shocks were normal side effects. Treatment for the event included Tylenol.  Action taken with mRNA-1273 was unknown.  The outcome of event shocks on the ribs, was unknown.
Intense generalized pruritus and tachycardia. Vomited 6 times after vaccine administration. Mild face, eye, et lip swelling. Treated with 7.5 ml of BENADRYL and 7.5 mg IM DECADRON. Reaction noted within 15 min of injection, symptoms resolved within 45 min of injection observed in office x 45 min.
Received 1st anthrax vaccine in left arm, and within an hour, I developed a migraine on the left side of my head. I took some Exederin Migraine, and for three days, the headache still lingered. The headache was from the base of my neck to my temples. Felt like a beating drum.
I gave a full dose flu vaccine age 3 and up (0.5 ml) to a 2 year old child (child weight 36.4 lbs). This has been reported to parent and my supervisor.
Her arm is achy after getting the vaccine; This is a spontaneous report from non-contactable consumer(patient) via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (lot number unknown), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was achy after getting the vaccine on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
I experienced  swollen lymph nodes to my neck and was getting worse over course of couple of days. I went to see a doctor at Iowa  Falls Clinic.
everything smelt rotten and had a rotten, burnt chemical smell; everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (everything smelt rotten and had a rotten, burnt chemical smell), TASTE DISORDER (everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth) and SINUSITIS (sinus infection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAROSMIA (everything smelt rotten and had a rotten, burnt chemical smell), TASTE DISORDER (everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth) and SINUSITIS (sinus infection). At the time of the report, PAROSMIA (everything smelt rotten and had a rotten, burnt chemical smell), TASTE DISORDER (everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth) and SINUSITIS (sinus infection) outcome was unknown. Not Provided          Patient is using Antibiotic to treatment of symptoms. No concomitant medications were reported.
Morning after receiving vaccine, entire arm from shoulder to wrist was sore without redness. Following day, pt. woke up to find red patch of skin on left bicep. Area is warm to the touch and expanding in area. Red area is at a completely different location on the arm than the actual injection site.
I could feel something wrong at the time of injection. I made the comment that the serum felt too thick or that the needle was larger than normal. Within 1 hour I was hit with exhaustion. Body aches started within 4 hours. By 8 PM, I had terrible joint and severe back ache, extreme exhaustion, massive skull-splitting headache, felt feverish, terrible chills, all skin felt like it had the top layer peeled with a vegetable peeler, upset stomach, and stuffed up nose. I was unable to get out of bed for 48 (day 1 and 2) hours with the above symptoms. Then day (3-4), I was able to get out of bed and sit in a chair. I still had the joint/back ache, extreme exhaustion, headache, peeled skin feeling and stuffed up nose. Day 5-7 each day brought a slight relief of symptoms. On day 8, I felt mostly back to my normal self. I was just as sick as I was the last time that I had the actual flu (which was in 2012). The only difference was that I did not have a sore throat this time. I have been getting the flu vaccine for over 18 years without any reaction at all. I could tell something was wrong at the time of injection.
Dry throat, hoarseness, tiredness, difficulty breathing, throat spasm, difficulty swallowing, throat inflammation.  First she used 2 puff of Proventil, next day went to ER where she was given Solumedrol and Benadryl IV
EMPLOYEE REPORTED BEGAN ROUGHLY 12 HOURS FOLLOWING VACCINATION:  BODY ACHES, CHILLS, TEMP 101.5, HEADACHE.  RESOLVED WITHIN 48 HOURS.
Grandma came back to peds floor with patient stating that he went limp, vomiting, and was lethargic in the elevator after his WCC. He did receive vaccines and has a history of allergic reaction to vaccines but per grandma it was not to the ones that he received today.  Upon entering the room the writer noted that the patient was lethargic but would follow commands. His skin was cool and he was pale. RN stayed with patient in the room.  Dr. was pulled from a room to assess patient. At that time it was noted that his skin was bright red and he was starting to itch. He was gagging as if he was nauseated. No breathing difficulty noted.  22mg benadryl given per providers request at 1415.   Epi pen junior administered per providers request at 1420. Patient tolerated well.  Mom and Patient placed in wheelchair and patient was brought down to ED where father was waiting for him.  On the wheelchair ride down patient was talkative and skin was less red. He was no longer itching.  Transferred care to ED staff.    Was also given Decadron 10 milligrams orally and Zyrtec 2.5 milligrams in the ER according to documentation
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 18-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Initial and follow up information has been received from a consumer (also reported as mother of patient and office manager), and a physician, concerning the consumer's daughter, a waitress, who had no reported medical history and at the age of 15 months, in approximately December 1986, was vaccinated with a dose of MMR (lot # unknown). Subsequently, the patient developed a fever of 104 F, total body rash, and pneumonia after vaccination. The mother reported that her daughter was taken to the emergency room and was treated with acetaminophen. The physician confirmed that the patient's experience was neither life threatening nor disabling and that the patient was not hospitalized following vaccination with MMR. There was no illness at the time of vaccination. Follow up information from the reporter indicated that the patient recovered on an unspecified date. There was no product quality complaint involved. It is noted that the patient had a recent rubella titer that was positive. Additional information is not expected.
Statement: 2 days after vaccination with 1. H1N1 and 2 Seasonal Flu at the same time I saw dark spots in both arm pits. After calling to report it to the center. I visited my private physician and he advised me that it was not from the vaccination but a fungus and treated me.
Information has been received from a physician concerning a 23 year old white female employee with no allergies or medical history who on 10JUL2203 at 10:00 am was vaccinated intradermally in the left forearm with a 0.1mg first dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccine. The reporter indicated that the vaccination was inadvertently given ID instead of a tuberculin purified protein derivative PPD. The area had developed a three to four centimeter welt. Unspecified medical attention was sought and the pt was treated with cold compresses and Benadryl 50mg. At the time of the report, the pat had not recovered. No additional employee information was anticipated. A product quality complaint was not involved. Additional information was received from a physician's assistant which also indicated that the pat received an ID dose of  pneumococcal vaccine 23 polyvalent instead of PPD at her job site. The reporter indicated that she saw the pt for an adverse skin reaction for a work place injury. the reporter noted that on approximately 10JUL2003 the pt now had a local injection site hypersensitivity reaction which included erythema, itching, induration and pain. The reporter indicated that the patient recovered. Follow up information was received form the physician which indicated that at 10:00AM at 10JUL2003 the pt had local swelling and pruritus only. The patient was seen on 14JUL2003 and her arm looked fine and the swelling was completely resolved. There were no diagnostic tests or laboratory results. It was also noted that the pt had no adverse events following prior vaccination. The reporter indicated that the similarity in the products' names contributed to the confusion. No additional information is expected.
client presented for 12th grade school required meningococcal vaccine.  Nurse was given immunization encounter without a list of previous vaccines received by client and gave the requested meningococcal vaccine.  After the vaccine was given, the clerk gave the immunization print out to the nurse and it was discovered the client had the vaccine 6/2022 and did not need the vaccine given today.  No reaction to vaccine noted.
Pale target outline on injection site; Headache; Itchy, red, smooth to raised rash on chest, neck, upper arms, back, and possibly scalp; Itchy, red, smooth to raised rash on chest, neck, upper arms, back, and possibly scalp; Itchy, red, smooth to raised rash on chest, neck, upper arms, back, and possibly scalp; Flu-like symptoms; Feeling spacy; One day of just being really tired/fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Jun2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included early sjogren's, pre-diabetes, early osteopenia, fibromyalgia, irritable bowel syndrome (IBS) and known allergy to other things. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fish oil (OMEGA 3) and unspecified daily vitamin; both were from unknown date for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27May2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously received prochlorperazine maleate (COMPAZINE), cefdinir (OMNICEF) and ciprofloxacin (CIPRO) and experienced drug allergy and was sensitive to polysorbate 80 (MANUFACTURER UNKNOWN). On 17Jun2021, the patient felt spacy and was just being really tired for one day. On 18Jun2021, the day after the vaccine, the patient experienced flu-like symptoms for one day. On 19Jun2021, two days after the vaccine, the patient experienced itchy, red, smooth to a raised rash on the chest, neck, upper arms, back, and possibly scalp plus fatigue, headache, and pale target outline on injection site. The target was mostly gone in a day and the rash had lasted for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event flu-like symptoms was resolved on 19Jun2021. The clinical outcome of the events itchy, red, smooth to raised rash on chest, neck, upper arms, back, and possibly scalp was resolved on 21Jun2021. The clinical outcome of the event feeling spacy, one day of just being really tired/fatigue, pale target outline on injection site, and headache was resolved on an unknown date in Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Janssen COVID-19 Vaccine EUA I received the single dose at 10:40.  In approximately 11 minutes I started to experience shortness of breath.  I thought it was my N95 mask so decided to head to the car after my 15 minute wait period was completed.  After sitting down in the car I started the following symptoms:  shortness of breath, rapid heart rate, swelling of face, dizziness, weakness.  I sit in the car for approximately 15 minutes then headed home.  I had a driver (thank goodness).  I continued to have symptoms and what felt like elevated blood pressure (I did not have access to a pressure cuff).  After resting at my driver's house for about 5 hours I felt better and headed home.  The next morning the symptoms were less but still present.  In addition I had a slight rash on my stomach that wrapped around my back.  After approximately 48 hours all of the symptoms subsided.  My blood pressure had returned to normal also.  All swelling went down.
Had yellow fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 15-year-old female patient received BNT162b2 (BNT162B2), in Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: YELLOW FEVER (medically significant), outcome "unknown", described as "Had yellow fever".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events YELLOW FEVER and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300265006 Same reporter/patient/drug, different dose/event.;
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced vascular injury and itchy rash. On an unknown date, the patient experienced erythema of extremities, feeling hot and burning sensation. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the erythema of extremities, vascular injury, itchy rash, feeling hot and burning sensation were unknown. It was unknown if the reporter considered the erythema of extremities, vascular injury, itchy rash, feeling hot and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient had reaction to left upper extremity (LUE) that was massive (3.5 by 4) in size. Less than a year after receiving SHINGRIX, the patient's area of LUE became hot, red and burning that led her to follow-up with primary care provider who instructed her to place cool compresses on site. The area broke out into a rash that was aggravated, itchy and blood vessels broke out all around it. The patient was instructed to wait until 2nd January 2018, to get 2nd dose of SHINGRIX.