chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has a history of Vasovagal Syncope and felt like he was about to pass out but felt better after lying down immediately.
Sore arm in the evening for a few hours on the day I received my vaccine. That was not concerning but what was concerning is that my menstrual cycle started 2 weeks early (3 days after the shot). I may be in my forties but I am still very regular (have been for years and throughout this pandemic) so this is a big change for me. I am curious how my future menstrual cycles will be affected or if this is a one time deal (my hope).
S: I itching, swelling and redness after flu shot at 11:45 am today.  Left deltoid region, there is no swelling , no erythema, no tenderness. There is  a small injection site.   Local reaction to flu vaccination
Information has been received from a physician concerning a 15 year old male who on 23-MAR-1995 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 27-FEB-1998, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 20-NOV-2009 the first set of blood tests for IgM was < 1:10, IgG was 4.04 and serum amylase was 86. On 14-DEC-2009 the patient's 2nd blood test revealed IgM 1:10:00 and IgG was 12.76. On 18-NOV-2009 the patient experienced mumps (the date diagnosed was reported as 20-NOV-2009). The patient was afebrile and had parotitis. The outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
A physician reported that a female inadvertently received an ID injection of TD and subsequently, developed a "large" area of redness at the injection site. She was treated with hot soaks and recovered.
Mom noticed increased redness and blisters at injection site (L and R) thighs.
3:33 -- light headed, dizzy, sweating, headache 3:40 -- crackers and water provided with mild relief 3:45 -- shakiness noted in extremeties 3:50 -- observation time ended, pt remaining with symptoms, extracted to observation area 4:00 -- 159/107  78  12  100% pulse ox 4:05 -- shakiness noted to have stopped, pt states she feels better in the cooler environment, additional water provided 4:30 -- 148/103  74  12 100% pulse ox 4:45 -- Pt states she is feeling better and ready to go home.  No dizziness or shakiness.  Pt states mild headache.  Pt discharged to home.
Information has been received from an office worker concerning a 4 month old patient who was vaccinated with oral ROTATEQ (lot # 660548/0501X), (therapy date and dose not reported).  The baby died the same day ROTATEQ was given to the patient.  Per office worker, they had a memo in their office not to give any further vaccines to patients because one 4 month old baby died after receiving ROTATEQ.  The office is currently waiting for the autopsy report before they can resume giving vaccines in their office.  Per office worker, the patient is not a patient in their office.  The Director of Pharmacy from the pharmacy who dispensed ROTATEQ provided the name of the patient's physician and lot # 0501X.  Additional information was received from a pharmacist, indicating that this patient also received second dose of ACTHIB, PREVNAR and PEDIARIX on the same day that a second dose of ROTATEQ was given.  It was reported that the patient sought unspecified medical attention, physician.  The event was considered life threatening and disabling.  A lot check has been requested.  Additional information has been requested.
Information has been received from a 90 year old female consumer with no pertinent medical history and no known drug allergies, who on 17-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot not reported). There was no concomitant medication. On 01-APR-2009 the patient developed shingles and had pain on the left side beneath her left breast around the back. The patient sought unspecified medical attention. At the time of reporting, 02-APR-2009, the outcome eof the patient was unknown. Additional information has been requested.
5cmx7xm erythema dn swelling with central clearing on right thigh; no induration.
Patients husband called on 10/05 and reported she began having flu-like symptoms (fever (101 degrees), headache, chills, vomiting) at 8 PM on 10/05. He then called back on 10/06 and said her arm had swollen twice the original size and she saw her MD. MD gave her a RX for antibiotic and said she had an infection.
Fever of 101 or higher since 1/22.   Mouth sores starting on 1/24.   Rash on upper chest starting on 1/24.
Running a fever, temp is back; Extreme fatigue; Headaches, went to urgent care; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th October 2022, the patient received the 1st dose of Shingles vaccine. On 28th October 2022, less than a day after receiving Shingles vaccine, the patient experienced fever, fatigue and headache. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The reporter was told typically, people have a reaction to the second one. The patient received dose of Shingles vaccine on a Friday morning and by the afternoon was running a fever, extreme fatigue and headaches.  This lasted ten days before he/she went to urgent care where she ran blood work, all normal. The patient was put on a steroid. Later that day his/her fever broke and he/she was feeling better.  The patient took his/her last steroid two days ago and the temperature was back. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR157870, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR157870:Same reporter.
Inadvertently, vaccine was not mixed with diluent prior to administration  3 times the recommended dose of vaccine was administered to under age Error was realized approximately 4 hours after administration Parent was contacted; patient had no clinical signs of adverse effects at that time Follow-up planned
Started with a headache. Next day migraine and bodyaches. Day after that Migraine worsened and in a lot of pain with body movement because of bodyaches.
pt exp t102.5 & urine showed greater than 100 WBCs & bacteria; spinal fluid analysis showed a colorless, clear fluid w/ 70 RBCs, 6 WBCs, 6 Polys & 94 monos; directogen for group B strep was positive; CSF results suggestive for sepsis;
One of retinas have permanent damage; This case was reported by a consumer via interactive digital media and described the occurrence of retinal damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 hrs after receiving Shingles vaccine, the patient experienced retinal damage (serious criteria GSK medically significant). On an unknown date, the outcome of the retinal damage was unknown.   It was unknown if the reporter considered the retinal damage to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and 3 hours later had the worst reaction ever. Might be ok for some but be careful. The patient stated he/she was to the emergency room twice and the worst was it returns every so often. One of retinas had permanent damage. The patient stated he/she never had a reaction to an injection but guess there was a first time for everything. The follow-up would not possible as no contact details were available.
Redness at injection site and warmth at injection site, also mild pain/soreness at injection site.
Patient vaccinated however patient less than 18 years of age.  EUA specifies 18 years or greater.   No other adverse reactions noted.
BLOOD CLOT; HEART ATTACK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnic origin The patient's height, and weight were not reported. The patient's concurrent conditions included: plaque, and other pre-existing medical conditions included: Good physical condition with no cholesterol issues The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had blood clot which led to a heart attack. Patient went to cardiologist and had to live with taking daily medications and medical bills.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20211110262-covid-19 vaccine ad26.cov2.s -blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211110262-covid-19 vaccine ad26.cov2.s -heart attack. 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: MEDICAL HISTORY
other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a physician's office for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Patient was given Moderna 28 days ago (5/12) and received Janssen today (6/9).  Pt still ok at this time.
administer. Pharmacist administered single dose of adult epinephrine at 11:29 am and 911 called. Patient evaluated by EMS at the store and asked to be transfer the nearest emergency room for further evaluation. Patient refused to go to the ER and walk out of the store.
pt recv vax 24JUL97 & on 29JUL97 pt devel pruritic vesicles on waist which spread to chest, back, legs;1AUG97 pt was seen in a MD office w/hives;
This spontaneous report as received from a physician via company representative refers to a 14 year old, non-pregnant female patient. On 04-AUG-2014 the patient was vaccinated with dose of GARDASIL, (intramuscular to prevent HPV; dose and lot # were not reported). Concomitant therapies included ACCUTANE. On 04-AUG-2014 (reported as "later the same evening") the patient experienced hyperventilation, chills, fatigue and nausea. Patient sought medical  attention (she called the physician). None lab diagnostic studies were performed. No treatment was given for adverse events. The outcome of events was unknown. Relatedness between events and vaccination was not reported. Additional information has been requested.
My wife and I seem to be having memory problems that were  not evident prior to the vacinations.
7 inches rash around the injection site  Can forward picture  Should I take my second shot due 3/24/21
patient was supposed to get flu vaccine but was inadvertently given  moderna(covid) vaccine. Patient stated that he got 2 doses of Pfizer vaccine; Last dose he got in February of this year.  Consequently  pharmacist  gave him the fluzone HD  which he really wanted,  Patient was not upset  or worried. Rph explained that both pfizer and moderna come from Mrna sources. and remember not to get the third booster for pfizer.
I had fever and achiness the day after. Fever of 101 degrees. This was on top of an injection site reaction with pain.  36 hours after the shot I developed extremely swollen lymphnodes in my chest area, accompanied by soreness and pain. Along with this has been continuous (seemingly non-stop, as the issue has not been resolved) muscle spasms.
Right arm feels hard to touch, above the elbow, below shoulder. Treatment: ice to site, referred urgent care prn.
Information has been received from a physician concerning a 78 year old female who on 03-MAR-2009 (also reported as 30-MAR-2009) was subcutaneously vaccinated in the right arm with a first 0.65 ml dose of ZOSTAVAX (Merck) (lot # 663775/1789X). On 07-MAR-2009 the patient developed shingles after she had been given ZOSTAVAX (Merck). The shingles had "cleared up" but she presently had post herpetic neuralgia (PHN) ("10" on a 1-10 scale). At time of reporting, the patient was recovering. The patient sought unspecified medical attention. Follow-up information was received from a physician and medical records indicating this 78 year old female non-smoker who drinks one drink per day and has allergies to IMDUR and Sulfonamide, anaemia, coronary artery disease, atypical chest pain, gastrooesophageal reflux disease, transient global amnesia, anxiety, scoliosis, hypertension, cardiomyopathy, lung disorder and hyperlipidaemia and a history of erythematous papular eruption (approximately 20 years ago), chickenpox (1939), hysterectomy and an appendicectomy. The patient went to the emergency room on 07-MAR-2009 with complaints of left sided pain. No rash was noted by the emergency room physician on 07-MAR-2009. Urinalysis and laboratory values were normal. A CT scan of the abdomen and pelvis showed punctate calcification within the left kidney, representing a nonobstructing calculus; small cyst in the left kidney, stable from prior exam; hiatal hernia; trace left pleural fluid versus pleural thickening and chronic air space opacity in the left lower lobe. The lung findings were unchanged from prior scans. She was discharged to home in stable condition with VICODIN for pain. On 09-MAR-2009 she was seen at her primary care physician's office and an exam revealed a linear erythematous papular eruption on her left flank approximately 7 inches in length. She was prescribed ZOVIRAX 800 mg 5 times per day for 1 week. On 11-MAR-2009 the patient received a phone call from the emergency room and they stated she had a kidney infection. It was indicated it was "okay" for the patient to take CIPRO and the previous CT scan showed she did not have a kidney infection, but possible a bladder infection. On 16-MAR-2009 the patient finished her antiviral medication, but continued to have pain from the shingles and was prescribed PERCOCET 5/325 mg tablets 1 PO q 6 hours prn. On 23-MAR-2009 the patient continued to have pain from the shingles and was prescribed NEURONTIN 300 mg 1 cap PO daily for 1 week then 1 cap PO BID. On 03-APR-2009 the patient reported the NEURONTIN was "the best". On 01-MAY-2009 the NEURONTIN was stopped. A sample of the lesion was not collected. It was reported the patient recovered from post herpetic neuralgia (PHN). Additional information is not expected.
Fever; Chills; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 27Apr2021 at 05:00, about 15 hours after second dose of vaccination, the patient experienced fever, chills, and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment over the counter medication at home. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, and nausea 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.
I noticed a dime sized red  circle warm to the touch at  administration site on day 8.  No fever or pain.  On day 9, the red circle grew  and remained warm to touch. I called my PCP who advised Benadryl.  I took 1 dose of Benadryl and the redness and warmth seems to have gone away.   On  1/15 after first receiving the injection, (day 1) I had only normal localized pain at injection site for about 48 hours. No other symptoms.  So was very surprised to see this redness on day 8 Lastly, I had some initial  concern on 1/15 that the dose was administered lower than my deltoid.  I did have my local pharmacist look at arm to make sure it was in a correct area. He felt it was. I was concerned that it could have been subcutaneous instead of the intramuscular route advised. Pharmacist felt it seemed  ok.
Chest pain; discomfort, middle of chest/lung; gasp for breath every so often.; This is a spontaneous report from a non-contactable consumer. This 37-year-old male contactable consumer (patient) reported for himself that: A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Cal Poly Pomona/6208 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm right on 11Mar2021 16:30 (age at vaccination was 37-year-old) as dose 1, single dose for covid 19 immunisation. The patient had no other medical history. The patient had no known allergies. Medical history was not reported. The patient had no covid prior vaccination. The patient had not covid tested post vaccination. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. On 11Mar2021 18:00 the patient experienced chest pain, discomfort, middle of chest/lung, gasp for breath every so often. Ae resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events was unknown. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient began complaining of some right calf pain on 5/25/2021. This reporter is patient's mom, legal guardian, as well as an RN. After some home treatment patient reported the pain was feeling better. However, when she continued to complain of pain and then developed some other symptoms consistent with a DVT (slight swelling, increased warmth to touch behind her knee) I took her to the ER for evaluation on 6/2/2021.  Her Doppler report notes state, ?+ evidence of DVT in right lower extremity seen from mid femoral vein to Post Tibial vein (1 occluded, 1 patent). No Baker?s cyst seen  * Occlusive.?  To fairly note other possible contributing factors: Patient was taking birth control pills at time of DVT (for menses management). She also had 2 wisdom teeth removed in 5/2021. Also she had a period of time of extended sitting with her legs crossed on the night prior to her ED visit.   Further clarification of above noted facts: Patient has been taking birth control medication since she has been a teenager, has had two other wisdom teeth removed in the past and has always sat cross legged for extended periods of time nearly her whole life. Additionally, Patient began complaining of leg pain prior to the time she was sitting cross legged. Although all of these other factors MAY contribute to the likelihood of a DVT occurring, they have never caused a DVT in the past either alone or combined. The only new possible link to DVT causal effect was the she received her 2nd Covid vaccine three months prior.
I started having swelling in my hand (s) the night of March 24th. Then again on April 9th. My doctor sent me for blood work on April 29 then refered me to a Rheumotologist. I have been diagnosed with RA. I never had any symptions of this and have heard it is unusual to get this at this age of life.
Low grade fever the first day and slight headache. Second day fatigue, headache, some chills and low grade fever. Some itching at the site and arm where shot was very sore for several days.  I still feel some fatique after 4 days but not nearly as bad as the first couple of days. All minor symptoms.
Information has been received from a registered nurse concerning a 13 year old patient of unknown gender. Patient's medical history and concurrent condition were not reported. On 24-OCT-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot 3 J004157 expiration date 09-MAY-2014 (dose and route not reported), which was improperly stored and expired. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 12/1/98; 1 hr post vax pt exp sore/ red/ swollen/ warm/ indurated vax site; tiredness
This case was reported by a physician and described the occurrence of headache in a male pt who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis.  The pt's medical history included hepatitis A infection, hepatitis B infection, and HIV infection.  There were no concurrent medications.  On 09/16/2003 the pt received the 1st dose of Twinrix; it was not known at the time of immunization that the pt had previous hepatitis A and B infections.  One day post-immunization, on 09/17/2003, the pt experienced "severe" headache.  The pt was seen by the physician.  The outcome of the event is unknown.  The physician considered the headache to be possibly related to vaccination with Twinrix.  The Twinrix immunization series was discontinued because of the previous hepatitis A and B infections, not because of headache.
At around 6:30 PM on 7-22-20 - All of the sudden patient's body started shaking and he had a severe headache and body aches. When patient arrived at hospital his temperature was 102.8 degrees.
Patient had been  administered with Pediatric Pfizer vaccine (5 to 11yrs) . Pediatric Vaccine is not strong enough get protection. He was contacted to get revaccinated. Patient has not been back yet to Pharmacy