chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inital reaction started one week post injection, there was swelling, redness, itching below the injection site, measuring approx. 1.5 in by 2 in, first noticed around 8:30 pm when getting ready for bed. Sensation was similar to a bad spider bite.  24 hours later, the swelling was somewhat reduced, although the itching persisted and the redness spread, measuring approx. 2in by 2.5 in.  At 36 hours after initially noticing the reaction, swelling is almost gone, redness is still present and splotchy, and the itching is mild. No medications were used for symptom management other than calamine lotion the first night for the itching. Pictures of each timeframe are available if necessary.  I will be consulting with my PCP to see if an office visit is necessary. While symptoms are concerning, they do not appear to be emergent.
Resident noted with left eye drooping on 1/26/21. On 1/27/21, resident has left eye and mouth drooping.
fever; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received dose of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event was unknown.  Based on comment Pyrexia is Listed in CCDS also
I've had the same timing and pre menstrual symptoms for 5 years. After getting my booster both the timing of my period and the PMS symptoms have changed. My period started 2 weeks earlier than normal and has continued on that cycle for 2 months. My PMS symptoms have gotten more noticeable as well (mood swings). No other changes in life style, diets, and medications have occurred so the booster is the only variable.
immediately after vaccination @ site of vaccination a bump formed most-likely due to vessel damage w/ needle contact. Instructed patient to apply cool compress or take tylenol for discomfort.
10 am on 02/25 moderna vaccine was administered and patient waited the 15 minutes without incident.  She later called the the clinic at approx. 1300 and was complaining of feeling like her throat was swollen and she was having tingling in her throat.  She denied any shortness of breath or difficulty breathing.  Instructed patient to go to the ER immediately or call 911.  Patient states that she will go to the ER.   Spoke with the patient on 2/26 and she states that she did go to the ER and waited for 2 hours and symptoms started to resolve and she left the ER without being seen.  Patient states that she did not take any medication for the symptoms.  She was feeling fine on this day.
a little bit of sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021 (RA).  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension but controlled with meds" (unspecified if ongoing), notes: Hypertension but controlled with meds. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of sore arm".  Additional information: Reporter stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He states that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of the Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and he expected that and it was okay because he know that his body was working". After a day or two almost all of them went away except for a low grade fever. It's been 8 days and he still has fever which was a little less high than it used to be.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Spontaneous Coronary Artery Dissection which led to a heart attack and hospitalization from Sept 13-Sept 16.  Fatigue and unusual tiredness when physically exercising and mowing grass began April 10th and continued everytime with extreme physical activity until heart attack.  In the beginning wondered if adverse effect from vaccine then wrote it off getting older.  slight chest pains more of a discomfort began on Sept 11, then got worse on Sept 13th blood pressure was extremely high so went to emergency room at hospital tests were run and diagnosed with heart attack caused by Spontaneous Coronary Artery Dissection (SCAD)
mom called hlth dept to report pt has swelling to fingers on both hands occurring 24hr p/vax;denies any other s/s;
coughing productive began 1 wk ago green now; can't sleep because of drainage in back throat, mild fever lt side below shoulder blade throbbing; SOB; referred to ER;
Patient reported tachycardia, chills, and malaise. Patient stated that she treated her rapid heartbeat with some nitro tablets that she had.
Develop a blood clot lost vision in left eye due to stroke. I?m still in the hospital. I am 50 and had a stroke a week at getting that vaccine   TPA shot. Given. Clot buster
It was itching. The outside of my upper arm was itchy and I rubbed it and scratched it a little and the itchiness seemed to be centered at the injection site. The itchiness lasted for about 3 days. I have not been itchy today which is the 4th day so it seems to have gone away. It was not irritating me all of the time, I could concentrate on other things and be oblivious to it. But sometimes when I rubbed it I could feel a little bit of swelling again at the injection site. When I looked at it there was some redness that could have been caused by my rubbing or scratching, some redness on the skin.  I tried to located swelling when it first appeared but couldn't find any and I didn't notice any that was worrying.
Child received 3 vaccines on 7.15.13. Had significant swelling, redness, pain in left arm on 7.16.13. Office visit with MD on 7.17.13. Given rx for antibiotics.
shaking; sick to the stomach; felt weak; chills; slight fever 100F; headache; arm was very painful during injection; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (slight fever 100F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event.  The patient's past medical history included SARS-CoV-2 infection in December 2020. Concomitant products included PRAVASTATIN and ATENOLOL for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was very painful during injection). On 22-Feb-2021, the patient experienced TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (slight fever 100F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (slight fever 100F), HEADACHE (headache) and VACCINATION SITE PAIN (arm was very painful during injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100f (Inconclusive) 100F. On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt experienced  fever (102-99 degrees F)and chills starting 3 days after receiving vaccinations. Also had headache and right-sided neck swollen and tender gland(s). No stuffy nose,or sore throat. Malaise for 2-3 days feeling better by day 8.
Pt recv vax on 12/15/98; on 12/16/98 pt exp pain in shoulders, Rt arm pain-like muscle separated; tx=ice, Advil, rest
Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Diffuse myalgias, fever, fatigue for 3 days, swelling, erythema, tenderness to left upper arm.
Felt like an old man; Gout flare/gout attack; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got Pfizer vaccine and a huge gout flare/ gout attack the next day. Felt like an old man, but better now. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 11/17/2022 I had a sore throat, runny nose, and cough. On Monday I went to the urgent care. I tested negative for COVID-19; flu; RSV. The urgent care told me that I had a sinus infection. They prescribed me with antibiotics for 7 days and cough pills as per needed. As of today 12/09/2022 I am feeling better now.
ELEVATED HIVES/ RASH, TREATED WITH PREDNISONE, BENADRYL AND TRIAMCINOLONE 0.1% CREAM.
This spontaneous report as received from a physician refers to a non-pregnant patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 10-DEC-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (injection, lot #J014855, expiry date 16-APR-2016, 0.5 ml, intramuscular) post not supported temperature excursion. Patient didn't report any adverse effect. This is one of several reports received from the same source. Additional information has been requested.
Narrative: Unclear of reaction the patient experienced. Documented as "internal shingles" requiring management in the emergency department following administration of 1st dose of Moderna covid vaccine. This was at an outside ED as no additional information is available regarding the nature of the reaction or any treatments that were administered to manage the reaction.
pt c/o having h/a on 10SEP92 inc intensity ea day; c/o stiff neck early on 10SEP92 that went away then came back today 16SEP92 inc in intensity; stated sore throat, achy chest & pain @ fingers today;
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 2:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 68.99. No concomitant medication was reported by reporter. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 8:00 Am and 9:00 AM . This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Normal pain at injection site. Approximately one hour after injection I passed out, when I woke up I barely had the energy to call my son to come take me to the hospital immediately. I arrived unconscious. I was there in icu, lost my vision for a short time, lost my ability to speak for a short time, couldn't chew my food, partial paralysis, and was eventually diagnosed with covid-19. I was not in contact with anyone showing signs of covid, nor did I have any symptoms myself.
Patient presents today for point of care (walkin) f/u due to potential vaccine reaction. C/o: erythema and hardening of skin to LEFT deltoid that began one day after SHINGRIX injection on 9/6/18. Objective: Verified ss/name, decline chaperone. 71yo male. Dressed appropriately, resting comfortably in exam room. Speaking in clear, full sentences. Has full mobility without gait abnormalities or assistive devices. Skin to left deltoid warm, dry, intact, erythematic (which he says is improved). Erythema measures 8.5cm x 9cm. Denies any prior vaccine reaction, itching, swelling, myalgia, fatigue, headache, fever. 09/10/2018 Addendum Status: Completed Seen patient. Left shoulder erythema at injection site for SHINGRIX vaccination about 5 days prior. He has noted regression of the erythema. On exam aprox 4cm area of erythema, warm to touch, no fluctuance. Treating as possible cellulitis. Ordered cephalexin.
Patient reported at 6:40 pm that she had thrown up and was having nausea.  EMS attendant was on standby and took vitals:  129/89 BP, Resp 16, lungs clear on auscultation, pulse 104, blood sugar 69.  Patient reported she had not eaten since 12:00 pm.   Patient reported at 6:50 pm that her nausea was improving.   At 7:00 pm, patient had a near-syncope event and was diaphoretic.  She was placed in a wheelchair and taken to a private area.  She appeared struggling to focus, but was responsive to questions.  She developed a rash on her chest and an ambulance was called related to dermal, CNS, and GI symptoms.  On ambulance arrival, Diphenydramine 15 mg IV was given and patient was transported to ER.
My arms became sore in the evening. Around 3:00 am the next morning, I started to become chilled, headache, not well. I took my oral temp, it read 100.5.  I took Tylenol. I was not able to rest comfortably.  I had similar symptoms after the second dose. The only thing different was that my temp was higher, I believe it was a little over 101.  I continued to take Tylenol for the remainder of the day. I felt much better the next day, Saturday. My arms, both, are still a little sore, but not raging like the evening I received both injections.
temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   On 16th August 2021, the patient received Engerix B and Havrix. On an unknown date, unknown after receiving Engerix B and Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient received Havrix and Engerix B after a temperature excursion (exposed to freezing temperatures at minus 8 degree C for 7 hours and 24 minutes, which led to incorrect storage of drug. The reporter consented to follow up by email. The case has been linked with the case US2021173232 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173232:Same reporter
Patient had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Patient had a sore arm). At the time of the report, PAIN IN EXTREMITY (Patient had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-035643, MOD-2021-060009 (Patient Link).
A close relative of mine dies from suicide early this year. I started having panic attacks, shortness of breath, verge of tears, at the same time every day. In the summer I went to see someone to talk about what was going on. I have been put on WELLBUTRIN, and KLONOPIN as needed to help me get through the panic attacks.
shingles; Information has been received from a lawyer and an elderly male patient (pt) of unknown age regarding a case in litigation. Information about the pt's concurrent condition, medical history and concomitant medication was not reported.   In 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for prophylaxis.   On an unknown date, as a result of zoster of his receipt of vaccine live (ZOSTAVAX), the pt was caused to suffer shingles, including any an all of its sequelae. The pt had suffer severe personal injuries, pain, suffering, and emotional distress as well as to incur substantial economic damages. The use of vaccine live (ZOSTAVAX) cussed the pt injuries, harm and economic loss that the pt suffered and would continue to suffer. The pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt was informed and believed and further alleged that he would in the future be required to obtain further medical and/or hospital care, attention and services
23 year old female patient vaccinated at 10:55 am. with first dose PFIZER vaccine, while waiting for 15 minutes of observation. Patient presents localized skin eruption of approximately 1cm on upper left arm. Vitals are taken by paramedic DXT (79) patient reports no having breakfast.
1.6-fold increase in central nervous system demyelinating conditions like multiple sclerosis; 1.6-fold increase in central nervous system demyelinating conditions like multiple sclerosis; 7.6- fold increase lupus; 5.6-fold increase in rheumatoid arthritis; 15-fold increase in ovarian damage; Autoimmune adverse events; They found a 4.6-fold increase risk of serious autoimmune adverse events outcomes of gastroenteritis; 10-fold increase of irritable bowel syndrome in women and girls who were given the Gardasil vaccine.; I've seen young girls suffer premature ovarian failure, total body hair loss, and arthritis after taking the vaccine.; I've seen young girls suffer premature ovarian failure, total body hair loss, and arthritis after taking the vaccine.; I've seen young girls suffer premature ovarian failure, total body hair loss, and arthritis after taking the vaccine.; This spontaneous report was received from a physician via online article, referring to an unspecified number of female patients of unknown ages. The patients' pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.       On an unknown date, an unidentified Merck human papillomavirus (HPV) vaccine (name and lot number not provided) (strength, dose, dosage regimen, frequency, route of administration, anatomical location, and expiration dates were not reported for any vaccine) was administered to the patients as a prevention of the HPV.  On unspecified dates, it was reported that the patients were experiencing autoimmune events linked to the HPV vaccines. They found a 4.6-fold increase risk of serious autoimmune adverse events (autoimmune disorder) outcomes of gastroenteritis, a 7.6- fold increase lupus (systemic lupus erythematosus), 5.6-fold increase in rheumatoid arthritis, 1.6-fold increase in central nervous system demyelinating conditions (demyelination) like multiple sclerosis, 15-fold increase in ovarian damage (ovarian injury), and a 10-fold increase of irritable bowel syndrome in women and girls who were given the vaccines. The physician had seen young girls suffer premature ovarian failure (premature menopause), total body hair loss (alopecia), and arthritis after taking the vaccine.  The outcome of the aforementioned events was not reported.  The reporter considered the events to be linked to the suspect vaccines.  Upon internal review, multiple sclerosis, demyelination, ovarian injury, rheumatoid arthritis, systemic lupus erythematosus, autoimmune disorder were determined to be medically significant. Additionally, the reporter considered the event gastroenteritis to be serious.