chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had an extremely sore throat. It was so bad I could not swallow. I gargled with salt water and toughed it out. I did contact my doctor on 02/16/2022 because it was no improvement. My NP suggested to still gargle and take TYLENOL. I took a home test on the 02/14/2022 and it was negative and then on 02/17/2022 and it was positive. I had chills and occasionally was tired, but I kept going on with gargling. There was no change until the 19th, I reported to my doctor, and they offered PAXLOVID, and I declined.
Next Day:  large, red, itchy welts under arms, waist area, inner thighs gone the next day.
6:30 PM:  Strong heart beat,  shortness of breath, weakness and sinus pressure.  2 dats latter: Gout in right big toe. Next day and to this date: Shortness of breath climbing steps, joints hurting from waste down.  Low energy.  Fine body shakes. Require naps. Chest plate hurts when pressed. Waking up often at night while sleeping.
Wheal/flare 4-5 cm in diameter at injection site. Coughing/SOB that worsened to point the patient was unable to speak.
p/vax pt exp redness, warmth, induration & swelling at inj site
Day after shot, left arm swollen and hot. Week later, injection site swollen to size of quarter and hot. Diminished to dime size 10 days later with hard scab. Month later diminished to size of green pea with hard scab and redness. Still hot and swollen. Treated with Tylenol.
Initial unsolicited report received from a pharmacist in the United States on 08 December 2015. This case involves 68-years-old female patient who was vaccinated with a dose of Fluzone HD batch number, dose in series were unknown and dose, expiry date were not reported) intramuscularly in right deltoid on 04 December 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. On an unknown date, following the vaccination, the patient had developed internal radiating pain to the shoulder. It was reported that no injection site redness, swelling or pain. The patient's laboratory data corrective treatment was not reported. The patient was not recovered from the event. Follow-up information received from a pharmacist on 11 January 2016. Lot number and expiry date of Fluzone HD was reported as UI1513AA and 12 June 2016. Patient was vaccinated with the second dose of vaccine at pharmacy. Patient was previously vaccinated with a first dose of Fluzone HD on an unspecified date. Patient did not experience any other vaccinations four weeks prior to the current vaccination. On an unspecified date, patient experienced pain and inflammation in her shoulder. It was stated that even one week post vaccination after usage of Ibuprofen regularly for a week, she went to physician who prescribed a 6 day regimen of a Medrol dose pack for the pain and inflammation in her shoulder and when that regimen was finished patient started Cyclobenzaprine, a muscle relaxant for a few days until the pain was resolved and was assisted by an accopantonist. On an unspecified date, patient recovered from the event pain and outcome of the event inflammation was not reported. List of documents held by sender: none.
Vaccine induced DVT; acute hypoxic respiratory failure; This is a literature report.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: on 2 L home oxygen. The patient's concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "recovered", described as "Vaccine induced DVT"; ACUTE RESPIRATORY FAILURE (hospitalization, medically significant), outcome "recovered", described as "acute hypoxic respiratory failure". The patient underwent the following laboratory tests and procedures: imaging procedure: revealed right interlobar pulmonary embolism and, notes: right superficial femoral vein thrombosis without any provoking factors. Therapeutic measures were taken as a result of deep vein thrombosis, acute respiratory failure.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep Vein Thrombosis and Acute Respiratory Failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202200349264 Same article/drug/patient and different dose/event
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Headache, Myalgia, Fever, Loss of Taste Narrative:  Symptoms started day after injection and progressively got better over the next few days
Patient had a PREVNAR 13 vaccination done in August 2015. Ever since that injection she has had muscle aches, weakness and radiating pain on the left side. She was concerned about her heart so she came in and saw Dr. at the end of August in 2015. Dr.did have her stop her Crestor which gave partial symptom relief. Unfortunately, she still has persistent discomfort in that arm which she directly attributes to the vaccine. She is not interested in resuming Crestor at this time as she definitely feels that it makes things worse.
Identified after vaccine administration that patient was not 12 years old, thus falling outside the current emergency use authorization age for administration of Pfizer vaccine. Pt tolerated vaccine well, no known adverse events. I attempted to outreach to the family to notify them but was unsuccessful.
On 12/13/2022, I was having a cough, sore throat, and chills. I didn't have any fever yet, but still had the chills. I was also having body aches. The next day, the symptoms were the same and I was unable to work. I went to a local urgent care because I could not get an appointment with my doctor. They tested me for COVID-19, Strep, and Flu. I was positive for COVID-19. They prescribed benzoate and BROMFED DM. After beginning the medication, I was feeling better by Friday. By that Saturday, everything was gone except for the cough. I still have a bit of the cough today. I visited the urgent care clinic again yesterday. They informed me that I may have these symptoms for 6-8 weeks. They advised that I continue the medication, but to lower the dosage.
entire body ached; running a fever but did not check his temperature; it was kind of like a sick day where he got nothing productive done; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 58-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 02Apr2021 around 13:00-13:30 (Batch/Lot Number: EP7533, Expiration date: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included, had positive COVID-19 test from exposure that occurred between best guess 25Nov2021-30Nov2020. Had no symptoms and had digital thermometer was periodically taking temperature even though had no symptoms, works from home-took test because it was close by at the apartment complex, but was completely asymptomatic. Acute Bronchitis as a child from an unknown date and unknown if ongoing. Other vaccine prior to COVID vaccine with in 4 weeks was reported as second dose of Shingrix Vaccine shot, 2 weeks and 1 day prior to first Pfizer COVID-19 Vaccine. Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. Shingrix Vaccine second dose vaccine hurt a lot, but he was fully recovered from the Shingrix Vaccine and feeling fine by the time he got the first Pfizer COVID-19 Vaccine. Shingrix Vaccine first dose caller thinks was administered on 30Dec2020 or 31Dec2020: Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. The patient's concomitant medications were not reported. On 03Apr2021, when he woke up, the patient experienced, entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy and fever. Especially the first time because he didn't take any medication with the first dose side effects and was probably running a fever but did not check his temperature but was definitely running a fever the next day. The outcome of the events entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy was recovered on 04Apr2021 and fever was recovered on 05Apr2021.
10-15 minutes after administration, patient began to report severe chest pains. about 25 minutes later, patient requested for 911 to be called. claimed to have severe pressure on chest. operator advised to allow 1 mg of apsirin 81 mg to be administered. emts arrived and took patient to hospital. the next morning, patient was sent prescriptions of ibuprofen 400 mg and acetaminophen 500 mg to the pharmacy. upon pickup, it was confirmed that the patient is no longer experiencing pain.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 in right arm for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-NOV-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced covid-19 infection with harsh symptoms (dose number in series 2). The infection was confirmed by PCR (polymerase chain reaction) test (confirmed clinical vaccination failure, and confirmed covid-19 infection). The patient visited physician office for covid-19 infection (dose number in series 2). On 07-MAY-2022, the patient again experienced covid-19 infection (dose number in series 2). Patient got infected from his brother and the infection was confirmed by a rapid test (suspected covid-19 infection and suspected clinical vaccination failure). He reported that the symptoms of the second infection were not as bad (dose number in series 2). Patient reported that the vaccination did not prevent him from getting the disease but helped him with the symptoms. On 01-JUN-2022, the patient called to report exposure to Covid-19 positive individual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient 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.; Sender's Comments: V0: 20220602071-Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . 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. Therefore, this event(s) is considered not related.
Muscle weakness, Rapid pulse, Feeling like passing out. Lasted several hours. Had to have help getting to bed to lie down.  This was FLUZONE HD PF 15-016 INJ.
Around April 12, 2021, 1 or 2 teeth on the bottom right started to become sensitive to hot/cold and when I would chew. It felt like I had a cavity. I went to the dentist on April 22, 2021, and she confirmed I didn't have a cavity. She couldn't see anything wrong with the teeth in the area I was talking about. She tried to replicate the pain but had a hard time. She determined my enamel had come off and she tried to grind-down my tooth to fix. It was ok for a couple hours, but the pain did come back. I went back to the same dentist on May 25, 2021, and she still couldn't find anything wrong with my teeth. She asked if I had received the COVID-19 vaccine. I said yes and told her the dates. She said my teeth being sensitive and hurting when I chew is a result of the vaccine. She had spoken with other dentists who have seen this and there was nothing that could be done. The pain and sensitivity lasted until around June 14, 2021 and has been almost nonexistent since then.
No adverse effects reported; an expired dose of VAQTA was administered to the patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 08-OCT-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R021233 (verified to be a valid lot number), expiration date reported and established as 05-SEP-2019, for prophylaxis. No adverse effects were reported.
Information has been received from a pharmacist, who is also the patient's mother, concerning to her daughter, a 17 years old female patient. The patient's concurrent conditions included Guttate psoriasis. No medical history and drug reactions/allergies were ported. On 19-JAN-2016, 26-FEB-2016 and on an unspecified date in June 2016, the patient was vaccinated with the first dose, second dose, and third dose, respectively of GARDASIL 9, (concentration, route, anatomical location, lot number, and expiration date were not provided). Other suspect and concomitant therapies were not provided. On an unspecified date in July 2016, the patient experienced a "flare up" of her Guttate psoriasis. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the "flare up" of her Guttate psoriasis. The relatedness between the Guttate psoriasis and GARDASIL 9 was not reported. Additional information has been requested.
S/P 24 hours after H1N1 adm. at clinic-started itching R upper arm. Today (48 hours S/P) 8 cm blanching macular erythema.
uveitis; a lot of itchy eyes; Had a lot of itchy eyes redness for last several months; Blurry vision; This is a spontaneous report from a Contactable HCP (patient). A 44-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 22Mar2021 at the age of 43-year-old as single dose for COVID-19 immunization. Medical history included auto immune. The patient didn't received other vaccine in four weeks. Known allergies included cupronickel, latex and shellfish. The patient performed COVID tested (Nasal Swab) post vaccination on 17Oct2021 and result was negative. The patient was not COVID prior vaccination. Concomitant medication was none. The patient previously received cupronickel and levaquin, both experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 15Oct2021, the patient had a lot of itchy eyes redness for last several months thought it was allergies but now have blurry vision and uveitis and going on 9 days. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received and not specified. The outcome of events was recovering.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Uveitis. 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.
Approximately 10 hours after receiving the vaccine, severe aches and pains and headache occurred to the point of it hurting to touch skin, from head to toe. Eyelids hurt, soles of feet hurt. This lasted about 36 hours. Could not move without severe pain.
This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unkonwn age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Additional information has been requested.
Itching on the injection site; Rash on injection site; Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergic reaction to antibiotics (ciprofloxacin) and Iodine allergy.    On 11-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 PRURITUS (Itching on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE ERYTHEMA (Red injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE ERYTHEMA (Red injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Pt recv vax on 8/6/97; 4 - 5 hr later pt exp red, warmth &hardness of injection site.  From 11/17/97 f/u visit, pts Rt leg very red & swollen w/ knot; tx=ice & Tylenol. It was reported that a 4-month-old female was vaccinated with ACTHIB/DTP on 6-Aug-1997. Within 4 to 5 hours of injection the site became red, warm and hard. From follow-up of 17-Nov-1997 it was reported, "Right leg became very red and swollen. Also a knot developed. Advised to apply ice to leg. Also TYLENOL." Reportedly the patient recovered forn this experience. No additionla informatin was received from correspondence returned to manufacturer on 16-May-2000. This case is closed.
pt recv vax OCT97 & & NOV97 & presented to school nurse w/jaundice;lab eval revealed confirmation of hepatitis b;
Weakness, dizziness, lightheadedness. Na level 127. K level 3.4. Sodium dropped to critical level 111. Treated with IVIG 20 gm, 200 mL IV daily for Guillain-Barre syndrome.
Had fever, muscle aches and fatigue. Continues to have fatigue since getting second shot on 4/10. Fatigue varying in intensity but new since getting vaccine.
2.5 x 3.5 inch area of induration and erythema/bruising to right anterior thigh.  No tenderness or warmth noted on exam. No treatment, parent advised to monitor and call back with new/worsening s/s.
punctured vial that was used on the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial that was used on the patient) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for an unknown indication.     Concurrent medical conditions included Diabetes. Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for Diabetes, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), SPIRONOLACTONE, ATORVASTATIN, CARVEDILOL and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial that was used on the patient). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (punctured vial that was used on the patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
temp 100.5 chills, muscle  pain, injection site pain radiating to left armpit which last for 2 weeks