chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flashes; Large bruises; Bleeding right after injection; Broke up rash, rash was on her chest, back arm, and upper leg side but not on her hand and feet; Redness; Itching; A spontaneous report was received from a consumer concerning a 63-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and was bleeding right after the injection/hemorrhage and experienced events, having flashes/hot flush, redness/erythema, itching/pruritus, large bruises/contusion and broke up rash/rash.  The patient's medical history provided included allergy to prednisone. Concomitant medications reported included sumatriptan and vitamin.  On 04 Mar 2021, approximately few minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient was bleeding right after the injection, had flashes few minutes after the injection, had redness, itching, large bruises and rash broke up. The rash was on her chest, back arm, and upper leg side but not on her hand and feet. Her doctor is not comfortable to recommend that she take the second dose since she is allergic to prednisone and would not know what to treat her with if something happens. Treatment for the event included diphenhydramine HCl.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the event rash broke up resolved on 10 Mar 2021 and the events, was bleeding right after the injection and having flashes were resolved on 04 Mar 2021. At the time of this report, the outcome of the events, redness, itching and large bruise were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient complained of tingling in fingers that's worse on the side that she did not receive the shot.
It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess vaccine viability.
Pt came in to have her arm looked at. It had redness size of golf ball (flat).
Patient with single J+J vaccine admitted with COVID complications and positive PCR.  Provider d/c note:  "Patient is a 85-year-old female with a past medical history of heart failure with preserved ejection fraction who presents with acute encephalopathy and a fall.  Encephalopathy is likely multifactorial secondary to COVID, hypoxia and baseline dementia. After discussion with son, she has dementia and is likely at baseline (not even able to know her own birthday, dependent for ADLs). Family's goal is to keep patient happy at home. DC to rehab for acute rehab with hopes on having her return home after.   Encephalopathy- likely at baseline Dementia Patient has well known dementia and does not always know her own birthday at baseline.  She needs help with even basic care. likely multifactorial metabolic encephalopathy secondary to COVID, hypoxia, sepsis. CT brain no acute process. CTA right internal bulb 70% stenosis, multifocal intracranial stenosis, P2 segment occlusion on right MRI old lacunars, chronic small-vessel ischemia.  We will continue ASA per Neuro recommendations.  cefepime and Decadron also contributed   COVID-19 with hypoxia-resolved Now weaned to room air unable to determine symptoms prior to 12/14 Completed remdesivir x 5 d /Decadron x 10d   Pneumonia, possible aspiration versus superimposed community-acquired on top of COVID as above failing swallow secondary to dysphagia, no clear story regarding aspiration MRSA PCR negative discontinue vancomycin -completed 5 day course of IV antibiotics (cefepime)"
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 10 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860696A, A0860698A - A0860702A for the other reports).
Pt received her vaccine on 5/25/21, she started to have a HA right after being vaccinated. She then noticed small red and white itchy bumps on her arms, chest, and back that progressed over the next several days. She called the clinic today as they have not improved yet. She says she has never had anything like them before.
I have had pain in my shoulders and upper arms as well as my thighs and knees to the point where it is limiting my normal physical activity and ability to sleep.
Janssen COVID-19 Vaccine EUA was administered on Monday March 8th at 4:30pm.  On Tuesday evening of March 9th, I experienced stomach cramping, abdominal paid, and explosive diarrhea. I took an Imodium following this episode. Then on the morning of Tuesday March 10th around 9:30am, I had another round of explosive diarrhea.
very unwell/Not feeling well at all; chills; diarrhea/A little diarrhea; heaviness in her legs/Legs are heavy and weak; Nausea; she did fine but had a sore arm; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Jan2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history included sensitivity to penicillin and concomitant medications were not reported. It was reported that she had the first dose of the pfizer covid 19 vaccine on Wednesday 27Jan2021 and stated she did fine but had a sore arm. She stated that Saturday suddenly, the symptoms hit her, and she was very unwell, chills, and diarrhea that continued through today. today she had nausea, heaviness in her legs and not feeling well. She wanted to know if these are side effects or is this her body having an immune response to the vaccine. She had sensitive to penicillin, and she wanted to know the reason, she had an AE to the covid 19 vaccine. It was reported that she Took vaccine a week ago on Wednesday. Had no trouble at all. Saturday, it hit her out of nowhere. Not feeling well at all. Was at daughter's house and she went down with chills and a little diarrhea. Had no fever, and no headache. Was a little better on Sunday and Monday. It was reported that Today everything is worse. Legs are heavy and weak, was nauseous. Had no fever and no headache. The outcome of event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Abnormal hair  loss.  This is following my 3rd in (booster)  Covid vaccine by Moderna  Although I know it is not life threatening, it is very frustrating to have my hair coming out this much. My hairdresser and I both noticed it, she said she has many other clients showing the same symptom.
Severe headache, congestion, coughing, body aches, dizziness, weakness, chills, sweats, watery eyes, and today 02/02/2010 vomit which may or may not be related. Been trying sudafedrine hydrochloride, asprin, rest, liquids, vitamins and fruit
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with ZOSTAVAX subcutaneously (dose and lot # were not reported). It was reported that the patient received ZOSTAVAX on 30-SEP-2013 and 16-SEP-2014. No adverse effects were reported. Additional information has been requested.
Localized pain at injection site; pain in her arm pit to the touch and when she moves it; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231, Expiry: Apr2021); via unspecified route of administration on an unspecified date at single dose at left arm for covid-19 immunisation. There was no medical history and concomitant medications reported. The patient previously had BNT162B2 for COVID-19 immunization and experienced localized pain at injection site. Stated that the patient got the 2nd dose of the Covid-19 vaccine on an unspecified date (reported as Friday). She didn't have a fever or chills, but she did have localized pain at injection site which she also had with the first dose. She is calling because she still has pain in her armpit, to the touch and when she moves it reported on 08Jan2021, but there is no swelling, lumps or bumps. The patient stated that the pain has decreased; it's not as bad as it was when she first noticed it. The patient got the 2nd dose at 5:30pm, and had pain at around 8pm or 9pm that night. The following day was the height of the pain for the second dose, and it has been decreasing since then. The outcome of the event localized pain at injection site was unknown, while recovering for the event pain in her arm pit to the touch and when she moves it.
pt recv vax AUG97 & pt devel 15 lesions on hands & forearms;
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: Unknown) dose was not reported, 1 total, administered on 09-MAR-2021 at left arm deltoid muscle for prophylactic vaccination. No concomitant medications were reported.  On 18-JUL-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 antigen (rapid) test (NR: not provided) Positive. All laboratory tests were performed at a medical clinic not at primary care physician. The patient experienced confirmed clinical vaccination failure and confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186483.; Sender's Comments: V0: 20210741174- COVID-19 VACCINE AD26.COV2.S -confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt presented for second dose of Pfizer COVID vaccine. Pt reported having throat swelling/possible anaphylactic reaction with first dose. She was unable to obtain release from physician to waive vaccine mandate to keep her job. Pt was given 25mg diphenhydramine liquid as pre-med and asked to wait 90 minutes in store. At 75 minutes pt began having symptoms of throat swelling. Pt was administered 0.3mg epi and EMS was called. Pt was transferred to local ED.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    ntramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.
hernia; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program reported for a male patient (reporter's husband). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had hernia. Reporter said that the patient (husband) would having surgery tomorrow (16Apr2021) for his hernia. The reporter and her husband got the 1st dose of the Pfizer Vaccine and their 2nd doses got rescheduled 4 weeks apart from their 1st dose. The reporter wanted to see if she can figure out how to get the Pfizer Vaccine 2nd dose in the three weeks that they need it. She wanted to know and was told that according to Pfizer guidelines, the 2nd dose should be 3 weeks from the 1st dose and not 4 weeks from the 1st dose, which might be the case and might be nothing; stated she does not want to waste the vaccine and get it and not be able to be vaccinated correctly; states she tried to schedule the 2nd dose at (place) the next day after her 1st dose was done and they told her to call back closer to her appointment date. She contacted (place) again and asked to reschedule the 2nd dose and they said there is no appointment for her on or after 21Apr2021 (which is the 3rd week after the 1st dose) and told her to come for the 2nd dose on 28Apr2021 (which is exactly 4 weeks from her 1st dose). The 2nd dose was scheduled for 28Apr2021 at 4:00 P.M.. She said that her husband was having surgery tomorrow (16Apr2021) for his hernia and she was thinking is it ok for him to have the 2nd shot on the 21st or is it better to wait for 28 days in his case. The outcome of the event hernia was unknown.  No follow-up attempts are needed. No further information is expected.
After 1/8 injection, arm painful for about 72hrs, then I did not notice it any longer. on 1/16 -site started to be sore again. on 1/18 - discomfort increased and I noticed it was warm to the touch, slightly swollen and light red. on 1/19 - no change really - maybe slightly less painful. no fever so far
Patient BF was given IM Tdap at 1750, then Rocephin 2 grams IM at 1825.  At approximately 1850 patient reported having itching/redness/hives.  Patient was given 0.3cc EPL 1:1000 SC/Benadryl 50mg IM/Solu-Medrol 250 IV mixed with 500cc NS (IV).  4L 02 via nasal cannula and transported to ER.
This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that the patient received first dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) at age 17 (exact date unspecified), the second dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) (exact date unspecified, reported as 8 years later) and was in the office by that time, on 18-DEC-2014 to receive the third dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). No adverse reaction reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. On unspecified date, patient experienced rash on body and lot of itchiness. Patient stated, "Ok I understand about the risk about this COVID-19. I already did my second injection. I understand about the side effect. Now the side effect that I had with the first time of vaccine was just the lot of itchiness and a rash on my body. It lasted like four maybe five days. Today I went and I took the second vaccine. I kept on reading in the paper they gave me but it doesn't say anything of side effect like you are drinking alcohol. Like they intensify the vaccine or no. Are there any side effects like if I had a beer? I took the second vaccine this morning and now we are in evening and I wanted to drink a beer. Would there be any side effect if I was drinking alcohol?" It was not clarified if consumer was drinking any alcohol. The outcome of the events recovered on unspecified date. The lot number for the vaccine (BNT162B2) not provided and will be requested during follow-up.
Date removed from freezer 8/9/22 . Thaw expiration date 9/8/22 @1100. Dose administered 9/16/22. Doses administered after 30 day thaw expiration. Moderna was contacted for assessment of vaccine activity for both doses. Based on the assessment vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration per Moderna.
Patient describes a muscular radiating pain in her left arm and extensive tenderness. Says pain has not improved and pain is spreading to neck.
first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR093987:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter
I tested positive for COVID-19 on 1/22/2023. I had a sore throat, postnasal drip, fever, fatigue, body aches, cough, loss of taste and smell. I contacted my doctor and was prescribed LAGEVRIO and VENTOLIN. I also took over-the-counter FLONASE. I was improving at days, but I still have fatigue.
Initial unsolicited report received from a non-healthcare professional on 23 February 2016. This case involves a 39-year-old female patient who was vaccinated with a dose of ADACEL (batch number: C2455AA, expiry date: 06 July 2008, dose, dose in series, and site of administration were not reported) intramuscularly on 10 April 2006. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 April 2006, same day few hours following the vaccination, the patient had developed jaw pain, locked jaw. It was very painful to open her mouth. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the symptom lasted for 48 hours and the patient was recovered from the events. List of documents held by sender: none.
Information has been received from a 70 year old female patient with blood pressure high, no drug reactions / allergies, who on 13-JAN-2009 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  The patient was on other medications but did not mention what medications they were on.  On 30-JAN-2009 the patient went to her physician's office and was diagnosed with the shingles.  The patient reports that she had the shingles on the front and back of her right tip.  The patient's physician gave her VALTREX, LYRICA and VICODIN to help with a rash, numbness and pain she was having with the shingles.  There were no laboratory or diagnostic tests performed.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
This spontaneous case, initially received from other non-health professional (consumer) on 24-Sep-2018, concerns a 76-year-old, elderly, female patient. The patient was allergic to neomycin and several other antibiotics. On an unspecified date, the patient was administered influenza vaccine (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported) which contained neomycin. No adverse event was reported. The reporter assessed the case as non-serious.
circular red rash at injection site.  about 2-3 inches in diameter.  Pt says it itches.
Right after shot, arm very sore. Later in the evening started more severe adverse response of headache, dizziness, sweating, severe cramping/pain of major muscle groups such as calves, thighs, back and neck muscles-- some difficulty walking.  Continued through the next day 8-21-14.  Improved but not abolished with 3 regular strength Tylenol every 4 hours.  By 8-22-14-- better only mild headache, general body ache, fatigue, arm is still sore, sweating, slightly light headed.  I have put a call into my doctor's office.  I received the vaccination at my work site which is a medical outpatient clinic. I was not able to work on 8-21-14.
Administered 1st dose of COVID-19 vaccination to patient 06/28/2021, 2 days past BUD. BUD for vaccination was 06/26/2021. Attempted to contact patient, however, unknown as to whether patient called pharmacy back yesterday or today. Waiting to hear back from Moderna regarding efficacy of vaccination administered. Will follow-up with patient accordingly and per Moderna instruction.
COVID Positive after being fully vaccinated. This individual also had COVID 19 in September 2020, was vaccinated, and has now contracted COVID 19 again.