chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA The patient was in his usual state of health until he received his second dose of the Moderna COVID-19 vaccine on Tuesday 2/23. He had previously had no side effects from the first dose other than soreness at the injection site. After the 2nd dose, he noticed arm soreness at the injection site more quickly than before. 10-12 hours later, he noticed headache and subjective fever, which was relieved by Tylenol. On Wednesday he woke up with subjective fever and chills, and felt sternal chest pain during deep breathing and attempted cough, but did not notice any effect from positional changes. Other than attempting to cough to elicit pain, he did not experience any other symptoms such as runny nose, coughing, sneezing, congestion,  shortness of breath, palpitations, abdominal pain, diarrhea, or dysuria. The following day, he noticed that the chest pain was more severe and persistent throughout the day.  The pain location would vary from the sternal area to the left side of his chest. The intensity of pain would vary between a 2-3/10 to 7-8/10. When the pain peaked, it would be accompanied by feelings of fever, chills, and brief headache, and he felt that the pain would "spread" across his chest. The pain would persist for a variable amount of time but then eventually disappear before returning. The pain was not affected by deep breath, position, or analgesics (he took an ibuprofen at around 2 AM when he couldn't sleep). After he fell asleep he was not woken up by pain. On Friday, he pain continued to be intermittent, and peaked during a work meeting. At that point he told his boss and an MD co-worker, who recommended that he presented to the ED. The EKG that was obtained in triage showed sinus tachycardia widespread ST elevations, PR depressions, with reciprocal changes in aVR. At this time he was continuing to experience chest pain. After getting a room in the ED, he no longer felt pain. He received a 2nd EKG showing improvement in ST elevations in some, but no all leads. He received ibuprofen and he continued to feel no symptoms. He was found to have a troponin elevation of 8.84 that peaked to 11.2. Transthoracic echo showed no motional wall abnormalities, normal EF, no pericardial effusion. He was admitted to the CICU out of concern and workup for myopericarditis.
2 weeks after my vaccination, I could not stop coughing and none of the inhalers that I use were helping the cough. I had increased wheezing and pretty much the symptoms of asthma. I reached out to my physician and I was given a new inhaler, TRELEGY, and was referred to a Pulmonologist. No improvement with the TRELEGY inhaler. It took me until late January to get in with the Pulmonologist. I was given a CT Scan and Pulmonary Function Test and was given another course of prednisone. I have started a new medication DUPIXENT. As of now cough has improved greatly.  Second dose of DUPIXENT next week and I won't see my Pulmonologist until May where we will assess if the drug is working.
Aching (L) arm, neck, shoulder, then the aching went into legs, hip. Returned to normal by 2/3/15.
pt recv vax 18DEC95 & mom reported on 26DEC95 lt leg red & hot from inj site;pt seen 26DEC95 put on amox;leg improved p/5 days on medicine;
Tired, achy, listless the following day of the injection (with both doses and the booster).
Breakthrough case admission after two vaccines Pfizer 4/13/21 Lot# ER8732;  Pfizer 5/4/21 Lot# EW0158
Swelling and hard lump around injection site, I noticed it about 24 hours after the injection  and it remains approx. 45 hours after the injection. The arm of the injection site has hurt since about an hour after the shot. I noticed some slight dizziness about 20 minutes after the shot but that was gone within about 10 minutes. I woke up with some congestion the morning after the shot.
Back of thighs swollen, red, hot with large hives approximately 10-12 hours post injection
jaw pain, stiffness. Started mild mid Tuesday 4/13 , moderate all day Wednesday 4/14, went to moderate/severe (woke up in middle of night) Tuesday/Wednesday, then back to mild 4/15.
4 bouts of  cramps/ diarrhea (1 the night of the first dose, 1 the following morning, 1 the following night, and 1 the following morning).  No treatment.
Pt recvd hep B vax on 0,1 & 6 month schedule & exp soreness @ inject site.  HBSAB test indicated lack of immunity.
Like I said I was on the antibiotics for the kidney stones. It seemed to be going okay. It as usually the chronic pain but manageable. I got the vaccine and started having major deep and burning pain. I emailed my doctor and he prescribed some additional medication. It was really bad for 48-72 hours. Once I started taking the pain meds, antibiotics the symptoms are back to moderation. The doctor couldn't figure out what the issue was so he attributed it to a reaction to the vaccine. He put me on Ketorolac, Ciprofloxacin, oxycodone. My symptoms are now mind/moderate. This connection completely surprised me.
pt recv vax 24FEB97 & 4JUN97 pt exp rash (breakthrough) w/approx 100 lesions which were particularly toxic;
I was putting together boxes for moving and out of no where I started cramping in my right arm shoulder and breast area. It so hurt bad I thought I was having a heart attack.  I was having a little nerve issue in and around the same area after having light Covid about 3 weeks ago.
Initially started scratching arm due to itchiness. At first only a small welt about 2 cm long visible where itchiness occurred. About 10-15 minutes later itchiness worsened and the area of itchiness was larger, slight redness noted but difficult to tell. Then 10-15 later that area of arm felt uncomfortable and slightly painful.  At that time noted red rash the size of my palm with induration, warmth and mild tenderness.
Both contracted covid virus after vaccine; Both contracted covid virus after vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for two patient (herself and her husband). This is a 1st of 2 reports. This consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient and her husband 1st dose of covid vaccine on 13Jan2021. Both contracted covid virus after vaccine. Supposed to get 2nd dose 03Feb2021. They were in quarantine. Wondering if and when they should get 2nd dose of vaccine. The patient experienced both contracted covid virus after vaccine in 2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111978 different patient, different event and drug
administered covid vaccine, answered no to all screening questions. Within seconds, while walking away after the shot, patient reported feeling dizzy, fell, bit tongue (bleeding), and appeared to be very stiff. It appeared that there may be troubl breathing, so the Pharmacist administer Epipen 00.3mg IM. Within 20 seconds, the patient became alert and oriented, was talking. Paramedics took to hospital. Update from parent said he was fine a few hours later.
Two weeks after getting my COVID-19 vaccine, I started feeling congested with a sore throat. Currently taking Sudafed and using a vaporizer.
Saturday, 29Jan2022, started violently vomiting; diarrhea; teeth were chattering; Friday night, 28Jan2022, started coughing a lot; Had normal onset of fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FL3209) at the age of 41 years as dose 3 (booster) single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1; lot: EK5730;  single; Route of administration: left arm), administration date: 18Dec2020, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2; lot: EL3246; single; Route of administration: left arm), administration date: 08Jan2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: COUGH (medically significant) with onset 28Jan2022, outcome "recovered" (31Jan2022), described as "Friday night, 28Jan2022, started coughing a lot"; PYREXIA (disability) with onset 28Jan2022, outcome "unknown", described as "Had normal onset of fever"; VOMITING (disability) with onset 29Jan2022, outcome "unknown", described as "Saturday, 29Jan2022, started violently vomiting"; DIARRHOEA (disability) with onset 29Jan2022, outcome "unknown", described as "diarrhea"; CHILLS (non-serious) with onset 28Jan2022, outcome "unknown", described as "teeth were chattering". The patient underwent the following laboratory tests and procedures: body temperature: (28Jan2022) 102 Fahrenheit. Therapeutic measures were taken as a result of pyrexia.  Clinical course details: The patient's teeth were chattering and had completely like fever like symptoms. Couldn't get out of bed 29Jan2022 or Sunday, 30Jan2022, pretty bad. The patient took Tylenol for fever.  Reaction assessed: Diarrhea, Cough, Vomiting, Fever Source of assessment: Primary Source Reporter    Method of assessment: Global Introspection    Drug related: Related; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I received my Covid -19 vaccine on 04/14/2022. On 06/30 I woke up with a cold and flu symptoms.  I called my doctor 07/01/2022 after I home tested positive for Covid-19. I was prescribed Lagevrio. I was told to take it twice a day for five days. Symptoms started to subside on day 5.
Itching; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE PAIN (Vaccination site pain). On 31-Mar-2021, PRURITUS (Itching) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product information was not provided.  Treatment was not used.   This case was linked to MOD-2021-100643 (Patient Link).
Initial report was received on 29 September 2011 from a healthcare professional. A cluster of two unidentified patients had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount time after vaccination, complained that they felt their throat was closing. Treatments were not reported. No further information was available at the time of the report. Outcomes were not reported. Documents held by sender: none.
a 63 years old male patient received an expired dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number Z42G4, expiry date 26-AUG-2023) for prophylaxis.   On 28-AUG-2023, the patient received the 1st dose of Shingrix. On 28-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: a 63 years old male patient received an expired dose of Shingrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 Medical Assistant reported that the patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up (email provided).
Patient was given Kinrix which contains IPV and IPV on the same day . This gave her 2 doses at once and 5 doses of IPV all together. No adverse reactions have been noted or reported.
4/23/2021: Diarrhea at 1 am and 6 am. Headache and nausea at around 1 pm. Fatigue at 2 pm. Dizziness and minor body aches at 4 pm.
Shingles; Ill-defined disorder; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 28-NOV-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On 08-OCT-2012, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for long-term prevention of shingles and zoster-related conditions in the local pharmacy. At the time of vaccination, the patient relied on the warning label affixed to Zoster Vaccine Live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that Zoster Vaccine Live (ZOSTAVAX)  was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect.Subsequent to the patient inoculation, the patient was treated by healthcare providers at Urgent Care, for shingles and other zoster-related conditions. As a direct and proximate result of the patient used of the Zoster Vaccine Live (ZOSTAVAX),  vaccine, the patient had and will 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 will continue to suffer such losses, and damages in the future. At the reporting time, the outcome of herpes zoster reactivation and post herpetic neuralgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Pt got the shot at 4.15 pm and came back at 4.40pm  She had swelling right face cheek, but had no sighs of fast heart beat or dissiness or shor ness of breath. No paleness or weakness present. No lumps on that side.
FAINTING, SEIZURE (NOT A FULL SEIZURE, BUT GOT STIFF)
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or pertinent medical history were not reported. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M035141, expiration date: 03-AUG-2018) (frequency and route of administration were unspecified) for prophylaxis. No adverse effects were reported. The temperature excursion details were as follows: Temperature: 6-14 Fahrenheit degrees Time frame: 1 hour There were no previous temperature excursions and the excursion was found because of a digital data logger.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L021216, expiration date 10-JUN-2017 (dose and route of administration were not reported). Tehre was no adverse effect reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
rash on both arms from the wrist up to the elbows; Some days the rash is red and some days it's not; it itches; This is a spontaneous report from a contactable consumer (patient).    A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  On 06Aug2021, the patient experienced rash on both arms from the wrist up to the elbows, some days the rash is red and some days it's not, it itches. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events included Benadryl and cream. The clinical course was reported as follows: Patient reports on 01Aug2021 she got the first COVID vaccine and is going to say 5 days later she got this rash on both arms from the wrist up to the elbows and it comes and goes. Some days it's red and some other days you can hardly see it, but it itches. Went to the pharmacy just the other day because she couldn't' stand it anymore. So she bought Benadryl and cream and was told to take 2 tablets that night, this all happened at night and she put on the cream. Some days the rash is red and some days it's not.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
After receiving Gardasil patient report site felt "fine" for 3 days.  On Monday 11/5/07 felt pain axillary area.  PMD ordered sonogram which found increased lympnadenopathy both axillary, pain stopped about 2 hours later.
Right arm 5 days after vaccine administration, patient developed rash on same arm in which she received shot (not at injection site). Rash did not itch and was not painful.
pt recv vax 18NOV96 & 24NOV96 pt to ER in clinical shock, w/ tachycardia;diagnostic test  echocardiogram revealed mitral regurgitation, poorly thin walled dilated heart;dx viral myocarditis vs congenital cardiomyopathy & pulmonary edema;
Expired Bexsero administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 10-MAR-2023, the patient received the 1st dose of Bexsero. On 10-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2023 The nurse reported that expired dose of Bexsero was administered to a patient. The reporter did not consent to follow-up.  The patient received expired Bexsero, which led to expired vaccine used.
Numbness, tingling, on the left side of the mouth and tongue.  Itching on the left shoulder.  No swelling or drooping.  All in the same dermatome.  No wheezing, coughing or chest pain.   Started 15 minutes after second injection.  Resolved 15 minutes later with no intervention.
Pain in left arm spreading to left side scapula now causing pain when she inhales. She is taking ibuprofen already at this point.
?COVID ARM?: red circle, tender, hard and warm to the touch, itchy below the injection site. Adverse reaction noticed on the 8th day after first dose was given. 1st dose given on 3/19/2021.  Delayed adverse reaction on right arm noticed on  3/27/2021.
Patient experienced pain in arm upon leaving pharmacy, the site then became red and inflamed. The next day she experienced shivering, fever, tiredness, and fever, she was then treated with antibiotics. Symptoms/infection has resolved and patients MD has recommended NOT getting second dose of vaccine.
COVID positive on 03/17/2022. After the my booster I started experiencing shortness of breath, fatigue and sore throat. The shortness of breath may be due to seasonal allergies.
Arm pain at site of injection, generalized body aches, slight fever, slight sore throat, headache.
Initial site red and raised - then continued to entire arm swollen, MD told her to take BENADRYL.
Patient experienced psychomotor symptoms; had one seizure at home and was transported to the hospital where she had another seizure.
daughter of patient called Pharmacy on Saturday 8/7/21 to report an adverse event of persistent high grade Fever of 102 degrees Fahrenheit which started as of  Friday 8/6/21 at 11:00pm after being administered Moderna COVID-19 vaccine around 3pm on 8/6/21  at Pharmacy. RPh was on duty Saturday 8/7/21 and suggested treatments to lower the high-grade fever by introducing Ibuprofen 200mg (up to 4 tablets 3 times daily if needed) with milk because patient could not eat food and suggested to continue use of Acetaminophen 500mg (2 tablets up to no more than 4 times daily if needed....1st dose was just given before time of phone call). Rph also asked questions if patient is a suitable candidate for the above treatments to rule out Liver disease, stomach ulcers, allergies to aspirin or acetaminophen and the use of blood thinners. RPh called daughter at 1:30pm  to follow-up and daughter confirmed patient's body temperature lowered to 99. 6 degrees Fahrenheit with fluids of Gatorade with ice.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The expiry date was reported as 09-Nov-2021  Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up documents received includes no new information.
On day 4, patient noted yellow fever injection site swollen (approximately 2.5 inches wide) inflammed and tender to touch, not itching. Denies fever or aches. Swelling has remained with slow improvement and inflammation has developed to bruise-like coloring and is still present but without discomfort at 36 days post injection.  As of day 41, discoloration is still present but swelling has diminished from onset but still present.