chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticaria with blisters to face then large patches of urticaria to trunk et extremities. Face - 4/19/13 at 6pm; body - 4/20/13 morning. Went to ER 4/19/13 at 7pm. Received steroid injection.
Lower left arm irritation and redness with acute puritis.  Onest  immediately after injection.   Administered 1 each 25 mg Diphenhydramine solution @ 1425 hours and second dose 25 mg Diphenhydramine at 1435 hours.  Irritation site redness reduced by 1440 hours.  Covered irritated site with moist paper dressing to reduce irritation  and reduce itching.  Client expressed relief from itching and was driven home by husband at 1445 hours.,
Arm was extremely sore/throbbed starting around 5pm on 12/19/2021, this was better around 3pm on 12/20/2021, although it still hurts when area around injection is touched.  Injection site has red mark (still red as of submission of this report).  Fever on Monday 12/20/2021 early morning (maybe 3am) which subsided approximately 2pm (took Tylenol at 6am and noon).
I had my second moderna Covid vaccine feb. 3. I had horrible muscle aches all over and violent chills with fever. This continued through the night and the next day. My headache was so severe I took a naproxen to help myself.
chills; headache; fever; muscle aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02TIA21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, CHILLS (chills), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA in response to the event was not applicable. Patient took the second dose of vaccine on 06 Apr 2021 with batch number 027B21A.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information was received on 12 May 2021 wherein contact details(reporter address) and 1st dose lot number was added, 2nd dose start date and lot number was added.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number 1, single (Batch/Lot number: unknown), as dose number 2, single (Batch/Lot number: unknown) and as dose number 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing); "allergic to seafood" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Morphine. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, treatment start date: 03Jul2022. Patient reported that she received vaccine and no other medication were received in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The immunization was mistakenly given Subcu instead of IM. Patient reported swelling, red painful rash at injection site. Advised patient to apply BENADRYL cream and ice as needed in addition to either TYLENOL or ibuprofen.
vaccine coordinator reports no adverse effects for all patients; Administration of 6 separate doses of an improperly stored vaccine to 6 separate patients; This spontaneous report was received from a vaccine coordinator concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not provided.  On 24-APR-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number: R021636 and expiration date 12-MAY-2021, intramuscularly (strength, dose, anatomical site, frequency were not reported) for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (°F) for 1 hour. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. No product quality complaint was involved.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011371:
Information has been received from a health professional concerning a female in her 30's with asthma who in December 2007 "sometime this week," was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# unknown). Subsequently, on an unspecified date the patient experienced irritation at the injection site, redness and swelling. No further information was provided. Additional information has been requested. This is one of two reports from the same source. Follow-up information has been received from a health professional concerning a 72 year old white female with asthma, penicillin allergy, sulfonamide allergy, drug hypersensitivity to flu serum and allergic reaction to LEVAQUIN who on 11-DEC-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# "1344U") at 11AM. On 11-DEC-2007, the patient called the office with complaints of swollen red localized reaction. The patient was icing and was to start BENADRYL. On 12-DEC-2007, the patient experienced some swelling but felt better. On 13-DEC-2007, the patient recovered. Additional information is not expected.
Information has been received from a Registered Nurse concerning a 38 year old female patient with penicillin allergy and medical history unknown, who on 14-NOV-2008 was vaccinated with first dose of VARIVAX (Lot # 658967/1521U), 0.5ml, subcutaneously. Concomitant therapy included FEMCON FE (was reported "FEMCON"). On 24-NOV-2008 the patient experienced chicken pox rash and diarrhea after she received her first dose of VARIVAX. There were no laboratory diagnostic studies performed. At the time of the report on 25-NOV-2008, the patient was "recovering". The patient sought medical attention by calling the practice. Additional information has been requested.
18SEP96  fussy;mom gaven APAP-nap or night time;19SEP cold sx, some fever;22SEP fever inc 104.5;arms sore;23SEP 3PM rash on stomach & back;rash in mouth & ears & meatus, painful urination;painful arm;
Client received AstraZeneca Covid vaccine with no reaction. Previous vaccine unavailable. Janssen given as an alternative on 10.3.21.
Information has been received from an RN concerning a 56 year old female pt who on 11/2/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 11/2/01, later that same day, the pt called her physician's office and reported that she had developed site swelling, site redness, a 102F fever and experienced site soreness. Unspecified medical attention was sought. Additional information has been requested.
No additional AE/PQC.; received VAQTA at 2 months and 2 days old. The child was supposed to receive PEDVAX HlB instead; received VAQTA at 2 months and 2 days old. The child was supposed to receive PEDVAX HlB instead; This spontaneous report as received from a medical assistant refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2020 the patient was supposed to receive haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. However, the patient was mistakenly vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 milliliter, frequency reported as once, lot # S037576 has been verified to be a valid lot number, expiration date 10-APR-2021 (anatomical location and route of administration were not provided) for prophylaxis. Therefore, the vaccine was administered to patient of inappropriate age. No adverse event was reported. The outcome of the events was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.; No Adverse reaction; Patient administered vaccine beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.) and NO ADVERSE EVENT (No Adverse reaction) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.).    No concomitant medication was reported.  It was reported that the vial was initially stored in the refrigerator on 30-Jun-2022.  Patient had received Second booster.  Vial did not undergo any temperature excursions.  No treatment medication was reported.
Pt described having low grade fever, up to 101F. Also with complaints of headache, general fatigue, ache in bilat upper extremities, over chest, back and neck.
-Started having headaches 2 weeks after the 2nd shot. They were headaches every other day for a short period of time and would eventually go away. They have gotten worse over time and turned into migraines everyday, I am nauseous, I throw up, and am very cloudy in the head. From the 2nd vaccine I have had these side effects for 6 months. There has been no change in diet, no change in exercise, no change in stress levels, the only changing factor has been the vaccine.
My husband felt generally tired and like he had a cold after the first moderna vaccine.  The second vaccine lot #020B21A on 3/31/2021, made him feel worse--more tired and joints hurting--more like flu.  He was slightly short of breath until a few days before his death, it got worse.  On the day before his death, he said he felt somewhat better, but I insisted we were going to call Dr. the next day on Monday.  He agreed.  Early Monday morning,  he went into severe respiratory distress.  I called 911.  He coded in the ambulance, and the code was continued at a local Hospital.  I was present.  He passed away in the ED on April 19, 2021.
Patient had 2 febrile seizures within 24 hours of receiving second set of immunizations. (1st:9:30am 3/20/07)(2nd:4:30pm 3/20/07)Approx.)  Patient was admitted to NSCH for evaluation.  Full work-up including LP was negative.  Tmax was 103.5. 04/17/07-records received without DC Summary. DOS 3/20-3/21/07. Contacted med rec, DC summary not required for short stay and pediatric patients. HX of Present illness:After vaccines, slept most of day, eating less than normal. Temp 103.5. Parent observed eyes blinking, crying screaming. Eye twitching continued for 15 mintues. Seen in ER,  DC home with DX of febrile seizure. Later in day whole body stiffened, eye twitching for 2 minutes.  PE:WNL. temp 100.7.
sick feeling in her stomach; wooziness; itcy rash on the same arm she received the injection; to develop a painful rash on the bicep; redness at at the site of the injection and pain; redness at at the site of the injection and pain; blood on the bandaid when she removed it from the injection site; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix. On 31st July 2020, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage. On 1st August 2020, the patient experienced stomach discomfort, wooziness, itchy rash, painful rash, injection site erythema and injection site pain. On an unknown date, the outcome of the stomach discomfort, wooziness, itchy rash, painful rash, injection site hemorrhage, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the stomach discomfort, wooziness, itchy rash, painful rash, injection site hemorrhage, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and there was extra blood on the band aid when she removed it from the injection site. The patient had a sick feeling in her stomach, wooziness an itchy rash on the same arm she received the injection but it was along the inner arm, not at the injection site and redness at the site of the injection and pain. The reporter asked was it normal to develop a painful rash on the bicep, not at the injection site. The patient still had some of the rash left and some pain but not as much as there was before.  The reporter wanted to know if had shingles in the past would cause her side effects to be more pronounced.  The reporter provided Medical Disclaimer, and PI from content and gave the reporter the number to had her HCP call Medical Information and sent the Shingrix PI through. The reporter did not consent to follow up.  The reporter stated she did not have any HCP contact. This case linked with US2020150010, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020150010:same repoter
The first day I just felt like I had a cold with a runny nose and sore throat.  That evening I took the COVID-19 test and it was positive.  The next day I got a Telehealth appointment.  My symptoms kept getting worse and worse.  I was very weak and tire and sleeping about 20 hours daily.  A lot of head congestion.  She phone in a prescription for Paxlovid and I started taking it the evening of December 29th 2022. I took the Paxlovid for  five days.  By the end of the medication I was feeling pretty good until I had a rebound but not as bad as the first wave.  It was a good two and a half weeks before most of the symptoms subsided.
Pt was receiving first dose of Moderna vaccine. Counseled pt appropriately on side effects and instructed pt to wait 15 minutes after receiving vaccine. Pt moved to chair right across after being vaccinated. Rph returned to work bench to continue tasks. Another pt nearby alerted pharmacy staff that pt had passed out. Rph and technician approached waiting area and saw pt lying on ground. Rph helped her up and had technician notify store manager. Asked pt if she was okay and had another staff member get her a bottle of water. Managers approached pt and gathered necessary information. Rph had pt wait 30 minutes and check blood pressure before she left. BP slightly elevated so had pt continue to wait. Pt reported headache and stated she wanted to go home and take Tylenol. Instructed her to call pharmacy if she experiences any issues on the way home. Left voicemail to follow up with pt.
Pain. redness, itching after 2 mos post-injection, specifically at site of injection.
Information has been received from a nurse concerning 9 patients between the ages of 4 months and 15 years who were vaccinated with Zostavax (Oka/Merck) rather than Varivax (Oka/Merck) (MSD) during the time period of 01-AUG-2007 and 17-AUG-2007.  None of the patients experienced a reaction, local or systemic.  This is one of several reports received from the same source.  Additional information has been requested.
pt recvd vax; 1 wk after vax pt exp'd fever w/ approx t 102-104; pt devel also welts on face that looked like chicken pox;
Patient received vaccine 10/23/10. Symptoms developed next day (30 hrs after) Hives, bodyaches, chills, fever, shortness of breath, muscle aches.
After 2nd shot she had a Fever 102F for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After 2nd shot she had a Fever 102F for 1 day) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (After 2nd shot she had a Fever 102F for 1 day). On 13-Feb-2021, PYREXIA (After 2nd shot she had a Fever 102F for 1 day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 102 (High) she had a Fever 102 F for 1 day.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-417433 (Patient Link).
Patient had the second Pfizer vaccine on Monday 5/17/2021 at 3:30PM. He was fine until Tuesday 5/18 around 3:00PM. He started feeling tired and had a fever. We gave him Tylenol and he was OK that night. On Wednesday 5/19, he had fever again. He took Tylenol again and was fine until the next day. On Thurday 5/20, he started feeling itchy on his legs. He claimed that he had some mosquito bites. On Friday night 5/21, He felt itchy all over his body, except his face. Now the red spots are bigger. Like mosquito bites but bigger. We gave him Benadryl and Cortizone. It helped.  On Sartuday 5/22, he had rashes again, we gave him Benadryl and Cortizone twice. It helped. On Sunday 5/23, it completely cleared.
fever 104 11sep95-rash, blister in throat, fever 103 13sep95 seen at Dr ofc, MD states its was MMR, T 105.7 14 Sep95-used meds for T,15sep95-severe diarrhea & dehydration
felt blegh; 24 hours of no energy; tired/ really fatigued/ wiped out from booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt blegh), ASTHENIA (24 hours of no energy) and FATIGUE (tired/ really fatigued/ wiped out from booster dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 013M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt blegh), ASTHENIA (24 hours of no energy) and FATIGUE (tired/ really fatigued/ wiped out from booster dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt blegh), ASTHENIA (24 hours of no energy) and FATIGUE (tired/ really fatigued/ wiped out from booster dose) outcome was unknown.            Concomitant product included Blood pressure medicine and Diuretic.
LEFT ARM PAIN AND TIGHTNESS ,PAIN RADIATES TO LOWER ARM, WARM TO TOUCH  TYLENOL, ICEPACKS
I developed a cough that?s worsened as my fever worsened the day after I got the shot. It?s been 11 days and I still have the cough and my chest feels weird and scratchy.  I also felt fatigued for about a week after and still don?t feel quite like I did before. I know several people who developed coughs with the vaccine. It should be LISTED as a side effect. I was tested for covid when my cough was at its wrost and the test was negative.
Received flu vaccine in right arm, had immediate pain, but worsened through the day. Pain going down arm, and in shoulder, pin prickling feeling, at about 10:00 am, after vaccine. Applied ice after my shift about 6:45 pm, when I got home, but symptoms worsened. Unable to sleep because of a feeling of a thousand pin pricks in my right shoulder. This is still continuing to happen. Sought medical attention, received steroid inj in right shoulder, and was given a gel to apply (Diclofenac sodium topical gel 1%).
does given to patient more than 6 hours after vial first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (does given to patient more than 6 hours after vial first punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (does given to patient more than 6 hours after vial first punctured). On 26-Feb-2021, EXPIRED PRODUCT ADMINISTERED (does given to patient more than 6 hours after vial first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.