chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said she began to feel bad when she laid down to go to bed. Started rash so took BENADRYL. When she woke up the next morning her lips had swelled and she was having trouble breathing.
On December 25th at about 8 pm I became extremely lethargic and unable to think clearly.  I had a temperature of 103.7. My face and tongue were swollen and I developed a rash on both lower limbs. I went to Emergency Room and was admitted.
Dizziness; Increased blood pressure; Headache; Loss of appetite; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:45 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Heart problems" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: The patient reported unspecified allergies to medications, food, or other products. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Dizziness"; BLOOD PRESSURE INCREASED (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Increased blood pressure"; HEADACHE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Headache"; DECREASED APPETITE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Loss of appetite"; FATIGUE (non-serious) with onset 26Mar2021 23:00, outcome "not recovered", described as "Tiredness". The events "dizziness", "increased blood pressure", "headache", "loss of appetite" and "tiredness" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, blood pressure increased, headache, decreased appetite, fatigue.  Additional Information: The reported age of patient was 64 with unspecified unit. The reporter classified the events as not serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Seriousness criteria: other-medically significant.  Initial report received on 07 January 2008 from a patient.  A 51 year-old female patient, with no pre-existing medical conditions other than a needle stick injury to the right hand on 09 November 2007, had received an intramuscular, right deltoid dose of Decavac (Lot number U1759AA), and an intramuscular, left deltoid dose of hepatitis B vaccine (Trade name, manufacturer name, and lot number unknown) on 09 November 2007.  Four days later (reported as 14 November 2007), the patient experienced pain at the injection site on the right arm where the Decavac had been administered.  She also experienced additional symptoms of "pain under her right arm, below the armpit, and above the elbow".  The patient was subsequently evaluated by a physician in the emergency room and was treated with Cephalexin for one week.  She returned to the emergency room on 23 November 2007 for re-evaluation, and was further treated with Biaxin and Amoxicillin, and was diagnosed with an "abscess".  The patient did not report if any diagnostic testings were performed.  At the time of this report, the patient had not recovered.
developed erythematous rash with blistery lesions, area, was itching/burning/tender to touch about 1 inch below the injection site
Immediate ear ringing and feeling fuzzy. Later chills body ache muscle aches. Next morning woke with red rash from chin to chest.still have dry bumps from rash today 4-1-2021
Heart racing , fever, and dizziness throughout day. Shortness of breath and chest heaviness from around noon (24 hours after shot) through at least midnight. Took inhaler and advil which helped reduce fever and improved shortness of breath, but was still left with some shortness of breath and all the other symptoms remained
Beginning early to mid April 2023 began experiencing allergy symptoms with a lingering cough attributed to allergies.  Treated with allergy prescriptions.  Early-to-mid May began experiencing sinus congestion.  Over the counter medications had no affect.  Additional symptoms began May 7 of mix of chills / feeling hot, sore muscles, and sore throat.  Doctor diagnosed as walking pneumonia.
6/25/21 Received vaccine. 6/26/21 In the morning pt stated she couldn't move left arm.  In the evening redness and blotches started appearing. 6/27/21 In evening, her arm was hot, and redness was spreading, painful. It took 1 week for redness and pain to go down.
received the FLUZONE HD QIV post transit duration excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 83-years-old female patient who had received the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] post transit duration excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included covid-19 vaccine for Immunisation.  On 03-Oct-2023, the patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (batch number: U8138DA; expiry date: Jun-2024) via intramuscular route in the right deltoid for Influenza and immunization, post transit duration excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial and follow up information has been received from a physician concerning a 39 to 40 yr old female, with unk medical history or drug reaction/allergies reported, who on 23Jan06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). There was no concomitant medication. On 24Jan06 the pt developed redness and swelling of the injected arm, pain, fever of 102, and shaking chills. On 25Jan06 the physician saw the pt and sent her to the ER. It was noted that the pt had possible cellulitis. However, the physician did not feel the pt's reaction was cellulitis. The pt was not admitted and was treated with cephalexin. On 27Jan06, the physician saw the pt and the symptoms still persisted. She started the pt on therapy with amoxicillin/clavulanic acid (Augmentin). On 01Feb06, the pt was seen again by the physician. There was still an area of erythema and pain, but the physician considered the pt recovering. No product quality complaint was involved. Additional information has been requested.
Mild headache , mild nausea .  3 separate events the next day 1/21 /2021 where I had sudden , no warning , fall to floor .  Possible loss of consciousness.   Today 1/22 no events of sudden falls or hitting floor
The same day of vax, the pt experienced a headache and flu-like symptoms. He recovered the same day without treatment.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of ROTATEQ orally, lot number M017514, expiration date 07-NOV-2017 (dose was not reported) were administered to the patients. No adverse effects were reported. On unknown dates, the doses were stored in the temperature 33.6 degrees Fahrenheit (F) for 19.5 hours which was detected by a digital data logger. No previous temperature excursion was reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000218:
I usually get a headache after vaccinations but it was worse this time. Half hour after vaccination I a had fever with chills and a few days later, and then I got a softball size lump under my left arm that was there 4 weeks. As I have MS, I see my Dr. regularly, so on my next visit (about 2 months later) it had gone away by then.
2nd covid vaccine afterward extremely fatigued and arm soreness for days. On 2/16/21 at 5am, left side weakness in my arm tingling and numbness in my fingers and toes very weak.
Patient felt dizzy and nauseated, felt like they might pass out. Cold rags applied to forehead and neck. Vital signs at 1104 BP=117/53 pulse=72 vital signs remained stable.
was given MMR on 12.17.07, patient may have been pregnant. Positive pregnancy test on 1/7/08. No LMP to determine gestation.
Running fever through day 02/19, and it spiked on 02/19 at 6 (highest reading 104.7 deg. F). Seizure ensued, about 5 minutes. No breathing, convulsions, eyes rolling, ended baby was extremely hot and irritable. Treatment at hospital-cool clothes, advil. Continued to run temp for next 2 days.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 Lot#EL3248 2nd dose 01/27/21,lot#EL9262 Diagnosed covid positive:08/07/21 Symptom onset:08/03/21 Exposure: Symptoms:muscle aches, cough, runny nose, headache.
The patient received a second dose vaccine that was Moderna and his first dose vaccine was Pfizer.
States day after immunization arm very sore and swollen. remains painful, teking Tylenol every two time a day. Talked to nurse at MD's office. Told to use warm compresses. Pain (2 weeks later) from site of immunization to elbow.
Enlarged/ painful axillary lymph node of same side as injection site; Enlarged/ painful axillary lymph node of same side as injection site; This is a spontaneous report from a contactable Nurse. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 08:30 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took fist dose of BNT162B2 (Lot no: EH9899), on 21Jan2021, 09:30 AM Left arm at single dose for Covid-19 Immunization. It was reported that on 12Feb2021 11:00 AM patient experienced Enlarged/ painful axillary lymph node of same side as injection site. There was no covid prior vaccination, there was no covid test post vaccination. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
30hr p/vax pt devel low grade temp, sleepy, eating well, had brief episodes <5min looked dazed sat/sun 5-10min 2-3x 1 day;no jerking, color change, or eye deviation by 17FEB no further spells;
Swollen lymph node in the left neck area, above the clavicle bone. The doctor estimated it as a 2cm swollen area.
Fast heartrate which inhibited ability to sleep; frontal lobe headache; low-grade fever and accompanying chills; joint ache; extreme fatigue; lack of appetite; swelling of area around eyes; redness of eyes.
This case was considered medically important (OMIC). Information regarding Hib vaccine (manufacturer unk) was received from medical records via an attorney regarding a male pt who experienced development disorder, left temporal lobe seizures and autism. The pt received a dose on an unspecified date. The pts concurrent illness included sleep disorder. Indication for Hib conjugate vaccine injection was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Medical records received from an attorney, alleged that on unspecified dated, the pt experienced pervasive development disorder, left temporal lobe seizures (convulsion) and autism. The pts outcome is unk. No additional information was available at the time of this report.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. On 08Mar2021 at 12:30, the patient experienced tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
On approximately October 13 I started exhibiting Covid like symptoms, chills, low grade fever, achy and tired.  Those symptoms subsided but I continued with a sore throat, headache and nasal and head congestion and cough. These symptoms gradually got worse and I made a appointment for a Rapid Covid test at pharmacy on October 26.  The test results were negative.  The following day on October 27 I saw a Dr. for the symptoms.  I was told I had Sinusitis and was prescribed Augmentin, Benzonatate for the cough,  and Sudafed for congestion.  The Dr. told me she has been seeing a lot of Sinusitis and positive Covid cases lately.   The antibiotic is s 10 day prescription and I am feeling back to normal now with no symptoms.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 26-MAY-2015 the patient was vaccinated with one dose of PNEUMOVAX 23 (dose and route of administration were not reported, lot # L003188 with expiration date 06-JUL-2016), which was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Rash to right arm, chest and back started immediately after vaccination. Hives and pruritus followed. Denies SOB. BENADRYL 25 mg PO at 1400 hrs and BENADRYL 50 mg PO at HS.
Patient received 6 doses of the vaccine all at once.  Nurse reconstituted the vial with 1.8 mLs of sterile water and administered the full vial.   Patient reported no side effects post dialysis treatment.  Checked with wife that evening and patient was feeling well with no side effects.  Next day patient stated he had no issues.
This spontaneous report as received from a medical assistant refers to a 9 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 02-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-July-2022 Reporter's comment:  This case was reported by a patient via Interactive digital media . The reporter stated that it was the worst things you would ever have. The patient had shingles and after the patient got over them, he or she took the first shot. The patient had an allergic reaction. The patient's doctor gave him/her medicine to take before he/she take the second one to keep from having a reaction. The reporter said that he/she rather had the reaction than the shingles.
Pt was seen at plant for 2nd Covid 19 vaccine with other employees. He had card with Pfzier identified as first Covid vaccine given. He was in line to receive Moderna 2nd vaccine per scheduled vaccines with plant. Advised partifipants they were getting 2nd Moderna and discussed my personal side effects as well as effectiveness of Moderna. After vaccine given one of coworkers noted half of employees, 5 people including patient was there for 2nd Pzier vaccine. Pt was advised of error and discussed potential side effects. He was monitored for 30 minutes with no adverse effects. Hours later contacted employer and pt remained asymtomatic. He is scheduled for recheck  exam. Pt did not have an adverse reaction.
Information has been received from a certified nurse midwife for the Pregnancy Registry for GARDASIL vaccine, concerning a 19 year old female who on 15-AUG-2008 was vaccinated intramuscularly with a first 0.5ml of GARDASIL vaccine. The patient sought medical attention at the practice. The patient's LMP was 05-AUG-2008. No adverse event. Follow-up information was received on 08-DEC-2008. It was reported that this was the patient's second Pregnancy, and she had one previous full term delivery. There is no birth defect and no infant complications in previous pregnancy. On 15-OCT-2008 the ultrasound showed intrauterine pregnancy 9 weeks and on 04-DEC-2008 MSAFP was performed. Medication taken during pregnancy included WELLBUTRIN, SR100 mg. BID, started on 06-NOV-2008 for depression. Additional information has been requested.
chill fever, cramps, headaches,  couldn't breath, blur vision, disoriented, weakness, no appetite, had to pee every 10 min.
pt reports persistent h/a, inability to sleep, felt feverish, since inj 18JUN98;
Narrative: bilat thigh pain 9 on 10 x 2 days since he received the second covid  vaccine. denies sob, cp, dizziness, weakness. states walking makes it worse. not  listed as a severe rxn on moderna fact sheet. but pain is "bad" per patient.  advised may come to ER for evaluation.
Red pimple rashes, some in clusters on different parts of the body including the legs and back; rashes are itchy, and her back is itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red pimple rashes, some in clusters on different parts of the body including the legs and back) and RASH PRURITIC (rashes are itchy, and her back is itching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol and Hypothyroidism. Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL TARTRATE (LOPRESSOR) for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red pimple rashes, some in clusters on different parts of the body including the legs and back) and RASH PRURITIC (rashes are itchy, and her back is itching). At the time of the report, RASH ERYTHEMATOUS (Red pimple rashes, some in clusters on different parts of the body including the legs and back) and RASH PRURITIC (rashes are itchy, and her back is itching) had resolved.            Treatment included cream to put on twice a day prescribed by a Dermatologist.   This case was linked to MOD-2021-020646 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Received follow-up information. Events outcome has been updated from unknown to recovered and treatment information added.
started vomiting 5min p/vax;temp instability & erythema of trunk & extremities, then chills & listlessness;may have aspirated vomitus;adm to hosp