chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patch was the size of a softball; Red Patch on right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.   Concomitant products included ATORVASTATIN, LEVOTHYROXINE, CALCIUM, VITAMIN B12 [VITAMIN B12 NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm). At the time of the report, RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm) outcome was unknown.      No treatment information was provided.  Patient had no adverse reactions after the first vaccination.; Sender's Comments: This case concerns a 71 years old female patient, with no reported relevant medical history, who experienced the non-serious unexpected event of Rash and the non-serious expected event of Vaccination site erythema. The events occurred the same day after the second dose of Spikevax. The rechallenge was not applicable for the events as no additional dosing will be given. Use of concomitant Atorvastatin remains a confouder to the event of Rash. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report
Pt recv vax on 7/12/95; 2 hrs later pt exp fever(103) for 2 days; pt exp fever (106) during that night.  On 7/13 -morning-pt exp perfusion to arm &legs (5seconds-blue); pt was staring.;after fever pt exp rash-1 wk.Pt dx=autism 1 yr later.
Woke up the morning after receiving the flu shot with swollen neck glands, difficulty swallowing, severe  malaise, dry cough.  Denies fever, hives, sore throat or other swollen glands. Gradually resolved over the next 2 weeks.  According to client, she called her physican, who said it was from the flu shot but since he didn't give it he didn't need to see her.  No treatment other than Tylenol.
Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022; Received expired vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported.  It was reported that the vials were initially stored in refrigerator on 30-Mar-2021 and was administered to 6 patient on 18-May-2022. The vial did not undergo any temperature excursion.  Treatment medications were not reported.
Injection site reaction occurred but nothing more than usual. Intradermal flu is only indicated for 18-64. Doctor is aware but there has been no follow-up by pt's guardian or doctor.
This spontaneous report as received from a register nurse and a VZV questionnaire, concerning a 72 year old female patient. The patient's medical history included shingles and breast cancer with metastasis, diagnosed three years ago (in approximately January 2011) and none allergies. On Friday 24-JAN-2014, afternoon (also reported as within the last 3 years) the patient was vaccinated with ZOSTAVAX lot # J011549 expiration date 19-DEC-2014, 0.65 ml, subcutaneous in the left arm per Oncology specialist request. Concomitant therapies included XGEVA, amlodipine besylate, letrozole, furosemide, metoprolol, LANTUS SOLOSTAR, NOVOLOG Flex pen, hydrochlorothiazide (manufacturer unknown) and levothyroxine. The register nurse reported that on 25-JAN-2014, 24 hours of receiving ZOSTAVAX the patient developed a "fist sized rash on her back that looks like shingles". The reporter explained that the patient was vaccinated in the afternoon on Friday 24-JAN-2014 and in the afternoon of Sunday 25-JAN-2014 she had a spot on her back (reported as center of back) that was itching and slightly burning. Also the patient's husband stated had noticed redden area size of a fist. The rash was described as raised red papules, number of lesions approximately 20 of 4 x 4 inches, herpes zoster dermatome. The reporter explained that the patient went to see her doctor on 27-JAN-2014 and it looked like shingles. A sample was obtain  on 27-JAN-2014 from the skin papule. The patient was treated with ZOVIRAX 200 mg once daily for 5 days. At the time of the report the outcome was reported as recovered (in January 2014). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
rash arm  IS; Itch IS; Swollen IS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash arm  IS), VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (rash arm  IS), VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS). At the time of the report, VACCINATION SITE RASH (rash arm  IS) had resolved and VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from an LPN concerning a child who was vaccinated with MMRII. The child's mother told the reporter that the child received the vaccine and a month later, was acting differently. The child was later dx'd with autism. The child's autism persisted. Follow-up information received from the LPN indicated that the child had received the vaccine from another physicain before coming to their office. She did not know who gave the vaccinations. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is available.
Day after the vaccine I was fatigued and had a dull headache much of the day. By the following day (April 30) I felt back to normal.
approx 1-2 mins p/vax pt had a gen sz lasting approx 30sec & was post ictal following;pt was afeb-because of vomiting the day a/& family plan to return to clinic in few day-pt was adm for w/u
Patient developed marked neck and thoracic back pain 1 day following injection.  She has required treatment with muscle relaxer, IM ketorolac, and narcotics
Case number PHEH2013US020576 is an initial spontaneous report received from the consumer on 01 Oct 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11074, expiry date: Feb 2014) on 26 Dec 2012. On the same day, he passed out striking the floor. He sustained a comminuted fracture in the extra osseous portion of the right upper center incisor and displacement of minor fragments anteriorly to the upper lip soft tissue. The event outcome, seriousness and causality were not reported. No additional information was available.
Exactly a week after receiving the vaccines client reports that she started to itch and then noticed a knot the size of a tiny mosquito bite. She then happened to pull her sleeve up and look at the area that was itching and that is when she noticed a bright red skin rash the shape of a softball.  Client reports symptoms lasted a couple of days following the immunization.  She reports taking Benadryl to help her pruritis.
Vaccine's given 6/22, fever started 6/24. Seen in office 6/27/01, fever to 105.5, no rash, runny nose, cough, loose stools x 2 days. Given Cefzil for Sinusitis. (allergic to PCN)
Unilateral submandibular facial swelling. Brought in by parents 7/27/05 with swelling on right side of her cheek for 1-2 days. Observation. 8/2 doing well, resolving nicely.
Paresthesias of mid-portion of upper lip and headache onset 30 mins after COVID-19 Vaccine given
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site rash and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The caller was a patient who reported that she experienced swelling, pain, rash and itching at injection site. The caller reported that issues resolved in 5 days after dose. The caller did not consent to follow up.
This non-serious spontaneous case, initially received on 19-Oct-2018, reported by other health professional (nurse), concerning a 2-year-old, female child patient. On 08-Oct-2018, the patient (less than 4 years of age) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019]. At the time of this report, no adverse events were reported. This case was linked to original case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Information has been received from a 64 year old female with no allergies and an unremarkable medical history who on 9/27/06 was vaccinated IM with a 0.65 ml dose of varicella zoster virus vaccine live (lot 652925/0621F). There was no concomitant medication. On 9/27/06, one hour after vaccination, the pt experienced itching all over her body. The pt stated that she did not experience itching at the injection site. No medical attention was sought and no diagnostic lab tests were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Additional information has been requested.
Rash at location of injection of the vaccine in the left arm. The rash presented on Sunday, May 9th and is still present on the arm. Onset of asthma symptoms and shortness of breath. These symptoms presented on Sunday, May 9th and are still present but being controlled by Albuterol HFA Inhaler HFA Aerosol Inhaler
Child received an adult dose 0.5 ml of Multi-dose Fluzone.  Should have received 0.25 ml.  No adverse events known at this time.  Contacted Sanofi Pastuer to see if anything needed to be done.  They said it shouldn't cause any harm to the child.  Parent contacted and notified of the stated med error.
Sick; 104 fever for 5 days; Initial information received on 31-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer via social media via Digital Media.   This case involves Adult and unknown gender patient who experienced sick(illness) and 104 fever for 5 days(pyrexia) while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient experienced a non-serious sick (illness) (unknown latency) and a non-serious 104 fever for 5 days (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported," Haven't had any type of flu shot or vaccine since 1994 and have never been sick,,, in 1994 my doctor convinced me to get a flu shot, 2 weeks later I had 104 fever for 5 days, eat healthy to boost your immune system".  No other relevant Laboratory details were reported.   It is unknown if the patient experienced any additional symptoms/ events.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of the reported events was unknown.  There will be no information on the batch number for this case.
high fever; body aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) and MYALGIA (body aches and pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-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 PYREXIA (high fever) and MYALGIA (body aches and pain). The patient was treated with IBUPROFEN for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PYREXIA (high fever) and MYALGIA (body aches and pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
around 10pm had hot and cold chills felt like he was getting the flu throwing up, unsteady gait, confused lasted until 3-4am went to sleep at 6am started to feel better  weak, dehydrated, sleeping off and on all day
24 hours post vaccine developed redness around the injection site on right arm. Redness spread throughout the day down right arm towards elbow. Redness still present but stopped migrating 48 hours post injection.
Fever (103°) chills and body aches lasting 28 hours,  (RESOLVED) swollen lymphnodes armpit has (NOT RESOLVED)
NO AE REPORTED, HOWEVER, DOSE ADMINISTERED IM INSTEAD OF SQ. PER BAVARIAN NORDIC NO REPEAT DOSE IS REQUIRED
Fever starting about 12 hours after injection.  Flu like symptoms  for 48 hours
Mild rash and burning skin on face, arms and chest. Benadryl every 4 hours takes away the burning sensation. When  Benadryl is discontinued it returns.
Early onset of menstrual cycle even while taking hormonal birth control pills. Cycle stated a week and a half early.; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 07:15 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. 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 COVID vaccine. Concomitant medications included unspecified birth control pill from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 07:00 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 20:00, the patient had an early onset of menstrual cycle even while taking hormonal birth control pills. The cycle stated a week and half early. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early onset of menstrual cycle even while taking hormonal birth control pills was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On July 2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On 21-JUL-2017 (reported as today), the patient was at the office for his second dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effect was reported.
No adverse effect, dose of 0.3 mL was given by nurse instead of 0.25 mL
Swelling and redness, pain at site initially started next day (10/3), today small ulceration at site, today (10/21) symptoms resolved but small crater at site, still recovering
Patient states that on 6/30/2018 she developed redness, inflammation and itching at injection site. She also complains of tiredness and not feeling well. As of today 7/2/2018 there is still redness with a defined border and inflammation and she still is feeling "unwell". I consulted patient to treat with ibuprofen for swelling and diphenhydramine for itching and ice pack as well.
vomiting, redness, swelling & bruise @ inj site;crying;bruise, swelling, redness 5MAR98;
Raised macular lesions, red, cool to touch, blanching. Topicourt LP apply and were a day.
The day after receiving the shot I had a headache that escalated to the worst headache I have ever had and soreness kicked in abo this day next day while body sore  felt nauseated that increased I could barely move without feeling like I?d throw up whixh I eventually did I say on the bathroom floor for hours I couldn?t eat or drink I had ice the course of a few hours three pedialyte pops eventually I didn?t want to move. Because it would make me more nauseated.  Terrible headache I fell asleep earlier in the afternoon I had to hold my Stomach and even turning in bed led to more nausea.  Finally fell asleep  dor the night woke up so far today I don?t feel nauseated I do feel dehydrated and I tried to drink Gatorade but drinking  from a cup aggravates it so only like ice chips or popsicles don?t aggravate my stomach    I felt like I was dying just laying on the floor for hours I laid on the. Ahg room floor because the tile was cool and I was near the toilet.  I tested positive for covid asymptomatic in October and then positive again in December with mild symptoms.  I never fully regained sense of smell or taste only partially even though that was months ago.  I wouldn?t wish that vaccine reaction in anyone   I was hesitant sins with already had covid to get vaccinated but was encouraged to do so.  I definitely won?t do that again ever.  It wasn?t that bad actually having COVID that was way worse.
This spontaneous report as received from a nurse refers to a 14 year old male patient without pertinent medical history, drug reactions or allergies. On 19-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9, 0.5 ml, (lot # and expiration date were not provided) which was administered intradermally instead of intramuscularly (incorrect route of drug administration). There was no concomitant medication. On 26-AUG-2015, the patient experienced injection site discoloration referred as skin discoloration and injection site mass referred as a lump at the injection site. The patient sought medical attention and WESTCORT cream 0.2% for 10 days was given as a treatment. No labs were performed. The outcome of injection site discoloration and injection site mass was reported as not recovered. Additional information has been requested.
pt recvd vax & got APAP & fever the evening of the shot got to 104.6; called MD & ordered more APAP in 1 hr fever came down; fever lasted 24 hrs & ran greater than 102;
Patient passed away Saturday at 14:04pm. Patient's wife reports his death was sudden, he passed away sitting in his chair his heart just stopped she said. They tried to perform CPR, 911 was called and paramedics arrived at the scene and he was given medication but never had any return of vital signs and so his death was called at the scene. Wife reports he was not ill, did not have any symptoms prior to the event. They are not going to be doing a autopsy. She wanted us to know based on timing that there may be some possible correlation with his COVID19 vaccine. He obtained the vaccine on 02/09/2021 - wife reports he had no symptoms, not even arm soreness after the vaccine. Had no fever, shortness of breath. Did not complain of chest pain. We can update chart to reflect the patient is deceased and lets make a card for the family.
second shot had very sore arm first day, next day felt like flu aching joints mild headache later that day broke out in rash all over body. had to go to doctor on april 22,2021. now on methylprednoise and cetirizine and i'm itchey and hot and feel bad
At approx 10:22 a patient reports ?that lady not doing too well?.  I instruct coworker to call 911. I run to patients side. Pt is complaining of being hot and I provide a water. Pt appears to be sweaty and sleepy. I provide a cold lemonade to see if helps. Pt continues to report being hot. Pt begins to intermittent respond. Pt complains ?my throat my throat? and scratches throat. Pt is having difficulty explaining what?s wrong. I give a 25 mg of Benadryl and instruct pt to chew. At 10:3 patients stated I can?t breath and scratches throat. I give first dose of 0.3 epi. Pt does not react. Fire department shows up 2 min later and evaluated vitals. Vitals are within range. Fire dept questions me and questions pt and pt cannot state name or location. After about 5 min ambulance arrives and begins vitals. Pt complains she is ?cold? and fights the blood pressure cuff. EMT states most likely panic attack.
pt devel t105, irritability p/shots; also had diarrhea times 3, appetite dec; seen by MD 10SEP92, t101; mom says gave APAP q4 hrs; MD recommends DT in future;