chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a patient (2 of 3) received a Tripedia vaccination, date not specified. Reportedly 24-48 hours after vaccination the patient developed a local reaction of swelling, redness, and erythema at the injection site. Further information is requested. From additional correspondence received on 5/7/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. From mailed correspondence received on 6/19/01, the patient's age and the date of vaccination was provided. Reviewed, no additional information at this time. From mailed correspondence received on 8/28/01, it was reported that the patient recovered from this experience. This case is closed.
Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became unresponsive in her wheelchair and became blue with no palpable pulse. Patient had a DNR status and was not revived.
Pt c/o itchiness in both hands,face and her chest.Stated got her 2nd dose covid vaccine Moderna @0842 this morning. Recommended pt to go to nearest Urgent care/ED for further evaluation of sx, Pt assure understanding. Pt denies redness or swelling, also denies emergency severe allergic reaction questionnaire at this time.
7-10 days post vax exp fatigue & h/a;2SEP92 pt had elevated liver function tests; 4-6wk post vax pt had joint pain & fatigue;MD stated pt had acute viral type illness, poss rxn to hep b vax;pt still has residual arthralgia, myalgia, fatigue
pretty severe headache within three hours fatigue within three hours next morning headache, dirrehea and nausea symptoms gone about 30 hrs after injection  several days later developed mental fog felt out of sorts.  lasted a couple of days  Had exactly the same side affects on the second shot given 3/25/21 at the same facility.  symptoms less severe in nature but lasted a little long.   Severe arm pain not necessarily at the injection site but same arm..   Woke me up with pain if I accidently moved or touched it while sleeping.  All resolved in 48 hours of vaccine.
Cystitis, urgency to urinate, pain in pelvis on left side, increased urinary frequency
Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC # 59267-1000-1.  0.3 ml given by RN.  Patient called his PCP: "... I had very bad chest and shoulder pains, neck pains and slight fever from 9 pm until early this morning (Jan 8).  My blood pressure was 155/95 mmHg.  Should I see you today?  Still feel sore all upper  body.  Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8):   patient was told that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the patient go to the emergency room.   Patient understood the importance to seek medical attention.....  Emergency Room notes: seen by MD on Jan 9.  Note at 0749:  patient complained of chest pain on/off since received COVID vaccine on Jan 7.  Pain was substernal and radiated to the left shoulder, assoc with some SOB.  EKG obtained and revealed ST segment elevation and a "cardiac alert" was called.
injected just below the deltoid area; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 3rd June 2022, the patient received Boostrix. On 3rd June 2022, unknown after receiving Boostrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: A pharmacist reported that a female patient received a dose of Boostrix that she believed was injected just below the deltoid area on her right side. No symptoms reported. The reporter consented to follow up. The pharmacist that gave vaccine was confidant it was given in deltoid. Additional Supportive Information: The patient received a dose of Boostrix that she believed was injected just below the deltoid area on her right side which led to vaccine administered at inappropriate site.
little soreness with first shot; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness with first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, EMPAGLIFLOZIN (JARDIANCE), METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (THYROXINE), METFORMIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (little soreness with first shot). At the time of the report, PAIN (little soreness with first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient mention she didn't even feel the shot go in when administered.  No treatment for the event was reported.   This case was linked to MOD-2021-054477 (Patient Link).
Information has been received from a physician concerning a 14 year old female who on 04-JAN-2008 was vaccinated intramuscularly with the first dose of GARDASIL. On 04-JAN-2008 the patient experienced fainting "5 minutes after being vaccinated." Subsequently, the patient recovered from having fainted. No further information was provided and no lot number was given. Additional information has been requested.
No additional AE; HCP called to report inadvertent administration of MMR-II to a patient on 08/29/2023 after experiencing a temperature excursion. Additional vaccines during the temperature excursion were administered to multiple patients (See AE case #02467645, #0246; This spontaneous report was received from a nurse and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinat human albumin (rHa) (M-M-R II) injection, 0.5 milliliter, lot #W028734, expiration date  08-SEP-2024, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -0.4 degree Celsius for 3 hours 32 minutes (Product storage error). This vaccine underwent previous temperature excusion in 0.5 degree Celsius for 32 minutes, in 1 degree Celsius fro 2 hours 1 minute and in 10.7 degree Celsius for 3 hours 31 minutes. No additional adverse event was reported.
Syncope 5 minutes following vaccination. patient had regained footing within one minute. Ambulance was called but no further treatment required.
During a review of the departments internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
I was stuck in nerve area and now I have weakness ALOT OF Pain all the time swelling itching ARM WHERE INJECTION STAYS WARM.
Mild shingles on left anterior costal margin. Started as soreness like a pulled muscle then 3 clusters of vesicles appeared 1 week later. At that time, PCP contacted through telehealth. Picture sent. Shingles diagnosed. Valtrex rx given. Symptoms resolved 1-2 weeks later. ghost
Patient described itching in the morning the next day after injection. Came back to office at 10 am. Pt was given Benadryl injection 1 cc left dm. Had hives on upper body, arms, face, not lower ext. Hives looked like chickenpox. Will follow up 8:00 08/18/2005.
she was around a baby and got another virus; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (she was around a baby and got another virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VIRAL INFECTION (she was around a baby and got another virus). At the time of the report, VIRAL INFECTION (she was around a baby and got another virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no drug reaction/allergies who on 17-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included pantoprazole sodium (PROTONIX). On 20-MAR-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) subcutaneously, 0.5ml once. After receiving the second dose subcutaneously the patient had an injection site reaction. The reaction consisted of pain and bruising at the injection site. No laboratory studies were performed. The patient eventually recovered on 03-APR-2007. She received the third dose of intramuscularly on 29-SEP-2007 without an incident. Medical attention was sought, the patient saw a physician. Additional information has been requested. 04/07/2008 Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no drug reactions/allergies who on 17-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included PROTONIX. On 20-Mar-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) subcutaneously, 0.5mL once. After receiving the second dose subcutaneously the patient had an injection site reaction. The reaction consisted of pain and bruising at the injection site (also reported as 06-NOV-2007). No laboratory studies were performed. The patient eventually recovered on 03-APR-2007 (also reported as 27-NOV-2007). She received the third dose intramuscularly on 29-SEP-2007 without an incident. Medical attention was sought, the patietn saw a physician. Additional information has been requested.
pt recv vax 16NOV98 & 17NOV98 appointment given;significant erythema & swelling in the lt arm from the shoulder ;later devel hives;
First episode of depression began after started Anthrax series. With 6th shot, depression relapsed, 2 days later, after having been well and off medications for 4 months. Although started Prozac again on 3/15/00, before 6th shot, which made me jittery and agitated and had depression symptoms again. Stopped Prozac and started on Serzone which made me have too much "brain fog" so stopped this, immediately. On 4/10/00, started on Zoloft and Ativan and is doing good, so far, on these medicines.
SORE SPOT; This spontaneous report received from a consumer via a company representative via social media concerned a 9 decade old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, dose number in series 1, 01 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sore spot (dose number in series 1). It was further reported that the patient had no breakthrough covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore spot was not reported. The patient received Moderna booster (MRNA 1273) (form of administration and route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series 2, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of Moderna vaccine (dose number in series 2). This report was non-serious. This case, from the same reporter is linked to 20220213343.  Version created to amend previously reported information on 04-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 and expiry date 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 13-month-old patient of unknown gender. On 21-JUL-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 04-FEB-2017. This is one of several reports received from the same source. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
(L) outer aspect of upper arm, above elbow red, swollen, hot, itchy-24 h after shot (R) inside aspect of upper arm-red, swollen, hot, slightly sore. 48hr after shot
Parent noticed redness and some blister-type rash at the injection site in the left thigh, yesterday, 12/4/05.
Intraocular pressure high; Shoulder pain; This spontaneous report received from a patient via a company representative concerned a 39 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Chron's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 19-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported.  On APR-2021, the patient experienced shoulder pain and on an unspecified date, the patient experienced intraocular pressure high. The patient had eye surgery due to eye pressure being too high. Laboratory data (dates unspecified) included: Sensation of pressure in eye (NR: not provided) too high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from intraocular pressure high, and shoulder pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210904340-Covid-19 vaccine ad26.cov2.s-Intraocular pressure high. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
During day 7 interview for "read" for smallpox vaccine, c/o "migraine" since day 2 (or 3), visual changes, faint feeling, fever, now also has cough, URI symptoms. Says when vaccine administered immediately got metallic taste in mouth. Exam: T99.4 c/o myalgias, fatigue, ears popping, headache 9/10, opaque 2x3mm grayish plaque on L tonsilar bed, (+) erythema, neck tender, acc nodes grape sized. Assess: viral syndrome, pharyngeal plaque-uncertain etiol. by MD. Day 8 phone to pt and subsequent exam: feels about the same; L/a 7/10 with no sx feeling of fainting or eye problems. States cough is worse, throat not sore but voice is coming and going. No fever, taking ASA/Tylenol. Nose more congested. Exam: T99.0 no change except cough now breaking up, nose is running more. OP injected, but no plaque/membranes or exudate. Assess: viral URI by MD.
Information has been received from a pharmacist refers to a male patient of unknown age. The pharmacist reported that on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number: K009770; expiry date: 09-OCT-2015) (0.65 ml, subcutaneous) which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Right upper extremity cellulitis.  Swollen, red, warm to touch.  Painful to patient at administration site.
pt recv'd vax & had knot in leg, generalized rash, diarrhea & crankiness;
Patient received 1-2 doses of moderna. Patient wanted moderna booster.  However, recieved pfizer by mistake..  Patient was informed and is ok with it
inflamed lymph nodes near her left clavicle (same side that she received the vaccine on); hives; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Batch number and expiration date: Not reported) via an unspecified route of administration on 23Feb2021 (Tuesday) on the left arm as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that since last Wednesday on 24Feb2021, she developed hives that have continued since she received her first dose. Patient wanted to know if it was ok. On 28Feb2021, the patient also reported two inflamed lymph nodes near her left clavicle on the same side which she received the vaccine shot). The patient stated that two inflamed lymph nodes were also worsening. The patient stated that she was currently treating the events with benadryl. Patient wanted to know whether she should get the second dose. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a physician concerning a 19 month old male with no known drug allergies and no pertinent medical history, who on 13-JUN-2007 was vaccinated with a 0.5 ml subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot# 657002/0337U). There was concomitant medication. On 01-FEB-2008 the patient developed pain in the right arm. The patient's parents informed the physician that he had become fussy and was shaking his right arm. On 02-FEB-2008 (also reported as "3 days ago", 03-FEB-2008), the patient developed a shingles rash down the right arm. The physician indicated there were about 30 to 40 lesions, and that it was a C-5 (cervical) distribution from the right shoulder down the entire arm. The physician reported that the patient had not had any natural exposure to the virus. Laboratory and diagnostic studies were not performed. At the time of this report, it was reported that on am unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Swelling of lymph node under left arm to size of lemon, pericarditis, left arm and left side of face numbness and tingly.
Beginning about 6 hours after injection, I experienced severe headache, night sweats, fever, chills, general malaise, muscle aches, backache without relief from acetaminophen and ibuprofen. After 2 days with those symptoms and the development of shortness of breath after the injection, I returned to the clinic with symptoms and complaints, and was told that I "likely had the flu" and that "if it was an allergic reaction, it was atypical and it would be too much paperwork" and sent home with prescription for Tamiflu and orders to take Zyrtec during the day and Benadryl at night. I did not take the Tamiflu, as no influenza screening test was performed and I was not convinced I had the flu.
pt returned form vax @ school site, pt reported that p/vax pt broke out in welts all over on the day of the shot;pt did not see a MD or seek any med attention;pt denied any other sx;denies any rxn p/1st shot;
Severe migraine headache, Imitrex (2 doses) did not resolve. Headache subsided after 12 hours. Next day sluggish/achy.
Received first COVID Vaccine in May 2nd; Rash developed post vaccine May 9th.  Biopsy collected on 5/34,  findings consistent with Cutaneous reactions reported after MODERNA and Pfizer COVID-19 vaccination: A registry-based study of 414 cases.  Journal of the American Academy of Dermatology.  April 2021 (Online ahead of print).
07/27/21 --Sore arm at injection, minor swelling. 07/28/21 -- 7:00 am Previous symptoms clear up, Symptoms that I had when sick with covid19 back in early February 2021 came back. Sore muscles, major migraines, sensitive skin(clothes felt like sandpaper) nausea, around 12pm took 2 liquid gel advil every 4 hours for pain. 07/29/21 -- previous symptoms gone was feeling normal. 07/30/21 --new dark spots that look like small bruises appear on forehead, penis, scrotum. No pain or itching. 07/31/21 -- oral ulcers appear on one lips and tongue, tongue was swollen and hard to breathe, went to ER for treatment. Was prescribed prednisone 50mg for 5 days and Hydrocodone 5/325mg tablets. Could only eat smoothie like food and drinks. 08/5/21 -- symptoms still persist, dark spots disappearing slowly. Still have oral ulcers but not as painful as before.