chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25AUg97 in ER w/sz sx of sz since 3mo old on dilantin;cont to have some sx on med;has followed up w/MD EEG nl;has been referred to neurologist;hx of sz to cont to have sz;
soreness in the arm; not feeling well; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm and not feeling well on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
vertigo; Headache; chills; fever; body aches; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself.  A 64-years-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 (at 14:30) (age at the time of vaccination was 64-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Ciprofloxacin facial tingling, Azithromycin nausea, Erythromycin nausea and Levofloxacin nausea from an unspecified date. Concomitant medications included Metro (METRONIDAZOLE) topical gel 0.75% 1 daily and Yuvafem (ESTRADIOL). The patient had no other vaccines within 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 09Apr2021 (at 07:00), the patient experienced vertigo, Headache, chills, fever and body aches. No treatment was received for the adverse events. Headache, chills, fever, body aches, began between 7 hours for headache and 12 hours later for the other symptoms. Resolved within 24 hours. Two weeks later, woke up with vertigo which lasted for 23 days, more severe at the onset diminishing over time. The clinical outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
burn scar; water blisters under the injection site; Burning sensation to injected arm under skin; Developed a lumpy red rash on injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (water blisters under the injection site), SCAR (burn scar), ADMINISTRATION SITE PAIN (Burning sensation to injected arm under skin) and VACCINATION SITE RASH (Developed a lumpy red rash on injected arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included HIGH BLOOD PRESSURE MEDICATION, ANTIHYPERLIPIDEMIC MEDICATIONS and Nucynta pain medication for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ADMINISTRATION SITE PAIN (Burning sensation to injected arm under skin) and VACCINATION SITE RASH (Developed a lumpy red rash on injected arm). On 12-Mar-2021, the patient experienced VACCINATION SITE VESICLES (water blisters under the injection site). On 25-Mar-2021, the patient experienced SCAR (burn scar). At the time of the report, VACCINATION SITE VESICLES (water blisters under the injection site), SCAR (burn scar), ADMINISTRATION SITE PAIN (Burning sensation to injected arm under skin) and VACCINATION SITE RASH (Developed a lumpy red rash on injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ice pack and Silver Sulfadiazine Cream.
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES 7/9/22-7/13/22
Info has been received from an RN concerning an 8 year old male with allergies; reflux and an allergy to Septra which caused a rash who on 4/19/01 was vaccinated, SC, with an 0.5 mL dose of varicella virus vaccine live (lot 636571/0928K). Concomitant therapy included Zyrtec. The RN reported that on 2/23/06, the pt developed a rash on his trunk. On 2/28/06, the pt was seen by a physician who confirmed the rash and noted it had formed scabs. A diagnosis of chickenpox was made. At the time of this report, the pt's chickenpox persisted. Additional info has been requested.  This is in follow-up to report (s) previously submitted on 5/12/2006.  Information has been received from a licensed practical nurse (LPN) concerning an 8-year-old white male with allergies, reflux and an allergy to SEPTRA which caused a rash who on 09-APR-2001 (also reported as 19-APR-2001) was vaccinated SC with the first 0.5 mL dose of VARIVAX (Merck) (Lot #636571/0928K).  Concomitant therapy included ZYRTEC.  Illness at the time of vaccination included night terrors.  The RN reported that on 23-FEB-2006, the patient developed a rash on his trunk.  On 28-FEB-2006, the patient was seen in the office by a physician who confirmed the rash that was "consistent with varicella".  The total number of lesions were about 50.  At that time, it was noted that the rash had formed scabs.  A diagnosis of chickenpox was made.  On 28-MAR-2006, the patient returned to the office for a follow-up visit.  The chickenpox were considered to be resolved as of 16-MAR-2006.  Additional information is not expected.
Patient received a Tdap 0.5ml, Hepatitis A 0.5ml in the left deltoid IM and Gardasil 0.5ml, Menactra 0.5ml in the right deltoid on 7/8/14. An all over raised, reddened rash "Allergic rash, as pts. physician claims" appeared 5 days later after vaccination. Pt. was seen by her physician on 7/25 and prescriped Predinsone oral X5days and hydrocortisone cream. Mother of pt. states pt. is now doing well and rash has cleared up.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of at the age of 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of at the age of 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of at the age of 17 years old) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.
Redness, heat, itching and swelling 3inches by 3 inches big at injection site.
Patient suffered ICH within 24 hours of receiving COVID vaccine. Symptoms include facial droop and mild dysarthria. Admitted to Neuro ICU for monitoring.
Severe body aches.  fever.  joint pain.  joint pain has lessened but not gone away.
On 6/25 caller got 2nd moderna vaccine.  States the next day he woke up with hives, went to ER and was treated with Benadryl and steroids.  States he has had several additional visits to the hospital since then and hives are persistent.
7/24/09 1300 client became pale, L head, wk, eyes rolled, shook 10-15 secs., SZ, laid client down - raised legs, P56 66, B/P 102/60, 1222, client answered questions appropriately, A10x3, radial/dorsal pedis pulse present, able to wiggle fingers, hands, toes, denied pain, denied problems breathing. Stated "didn't know what happened", denied numbness- states "I feel OK", monitored client 30 mins, 4X SZ in client 5yrs., HX SZ's in "aunt and uncle" states client/mom - client ambulated with strayed gait with mom at side with no further incidents. Client stated "had not eaten/hardly drinking by nurse.
I tested positive for COVID-19 on 8/8/22. I had a sore throat, fatigue, and congestion. I contacted my doctor and was prescribed Paxlovid. After finishing the medication, I tested negative for COVID-19. Not long after that I had stomach pain and took another test and tested positive again. I went to the Emergency Room and ran some test and found that I had a small intestinal blockage. They ran a tube up my nose and began sucking out the blockage. I had to have a bowel movement immediately and I thought the blockage was gone but they kept me for several days. They gave me a couple different medications, but I don't recall the names of them. On day 5 they gave me an x-ray and it showed the blockage was gone and I was released.
RECEIVED LESS THAN 0.5ML OF JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported expiry: Unknown), 1 in total, dose was not reported (dose number in series :1), for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series: 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (ml) of the Janssen COVID-19 vaccine as a booster dose (dose number in series 2) approximately around 0.3mL of dose (vaccine underdose which is off label use, dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen COVID-19 vaccine as a booster dose which is off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211210160, 20211210588, 20211210112, 20211210824, 20211209775, 20211209874, 20211210610, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211209679, 20211209706, 20211209798, 20211209843, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590 and 20211210662.
No adverse effects were reported.; 6 month old infant was administered one dose of improperly stored ROTATEQ; This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034878, expiration date 11-SEP-2020 (dose and route of administration were not reported) for prophylaxis. The reported vaccine was exposed to the temperature above 47 (53 F) degrees Fahrenheit for 2 hours and 15 minutes. The vaccine underwent previous temperature excursion of above than 47 (50 F) degrees Fahrenheit for 1 hour. A digital data logger was involved. No adverse event was reported.
Induration and erythema 10 x 12 cm on left shoulder with pain and itching.
About a half hour after I had received the J&J vaccination which was after I had left the vaccination site and was headed home I noticed that my right eye was impacted  by some kind of outline that looked like a spider or cockroach in black lines. The position shifted in light and based on where my eye was pointing. So it could be at the top or side of my view. This ghost image has been there ever since the vaccination.  I notice it every day.  My primary care doctor left his position and I haven't got a new one.  My wife spoke with her eye doctor who did not see my eye.  The doctor said that it was most likely caused by a bubble.  I have been able to deal with this distraction even though it has remained the same since it appeared.  I  became more concerned that a booster shot for the J&J might make my situation worse.   I also wasn't sure if I would have to have the J&J injected for the booster or could have a separate booster shot.
This spontaneous report as received from a physician via company representative (field employee) refers to a male patient of unknown age with hypertension and hypercholesterolemia. In 2011 (exact day unspecified) the patient was vaccinated with ZOSTAVAX, one time, subcutaneously (dose and lot number not reported). Other suspect therapies included PNEUMOVAX23 (dose, lot number and route not reported), given about the same time (in 2011) as receiving ZOSTAVAX vaccine. On an unknown date the patient developed a severely debilitating case of shingles. The physician reported that it was the worst case of shingles that they had ever seen in 30 years. The patient had also been traveling and it was upon his return that he developed shingles. There was unspecified treatment given for the event. The patient sought medical attention (doctor visit). The outcome of the event was unknown. Relatedness between the therapies and the event was unknown. Reporting physician considered shingles to be disabling. Additional information has been requested.
feeling tired; no energy; low grade fever that came on gradually (100.1, 100.6 and never got past 100); little soreness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on 06Aug2021 (at the age of 69-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little soreness on unspecified date in Aug2021, feeling tired, no energy, low grade fever that came on gradually (100.1, 100.6 and never got past 100) on 13Aug2021. The patient underwent lab tests and procedures which included body temperature: 100.1, 100.6 and never got past 100 on 13Aug2021. The events were not serious. Caller decided to get first Pfizer shot last Friday, 06Aug2021. Everything was fine, he just experienced a little soreness. However, he was feeling tired and has no energy at the time of this report. This started the day before this report, and he was not having any headaches. He wanted to know how long after the shot will the side effects show up and how long they last. Seven days after the first shot, started feeling all the effects, a low-grade fever that came on gradually (100.1, 100.6 and never got past 100), tired beyond belief and felt like he ran a marathon, and had no energy whatsoever on Friday, Saturday and Sunday (13Aug2021, 14Aug2021 and 15Aug2021). Friday and Saturday were tough days and Sunday it started to subside. He stated he called his afterhours doctor/nurse and they said if it gets worse come down. He stated it wasn't that bad, he let it ride out and the day before this report (yesterday; 16Aug2021) was fine. After providing the verbal response he stated he already got his answer because his symptoms came on after 7 days and subsided and everything was great. He was going to get his second dose on the 27th. Clinical outcome of events was recovered on an unspecified date in Aug2021.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Pt states he has pain in arm, unable to sleep
had one vaccine, Pentacel, that was given to a patient, after temperature excursion; temp excursion for the following vaccines: ActHIB, IPOL, Menactra, Pentacel.; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] after there was a temperature excursion of vaccines including MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route.  It was of actual medication error dose due to incorrect product storage and Deteriorated drug administered.  It was unknown whether any adverse event was experienced.  Information on the batch number was requested.  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 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.  List of documents held by sender: none.
Pericarditis; Atrium flutter; Extremely anemic; Night sweats; A spontaneous report was received from a consumer  concerning a male patient who experienced pericarditis, atrium flutter/atrial flutter, became extremely anemic/anaemia, and developed night sweats.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included sucralfate, mesalazine, metoprolol, escitalopram oxalate, colesevelam hydrochloride, multivitamin, vitamin D3, vitamin B 12 and fluocinonide.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch# 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, the same day as the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch# 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient presented to the emergency room with severe chest pain across his entire chest and entire jaw that was exacerbated when he took a breath. A pulmonary function test and electrocardiogram were performed (results not provided). The patient was admitted to the hospital with pericarditis and discharged 3 days later. Treatment included colchicine.  In Feb 2021 (date not specified), the patient experienced night sweats and had a blood test (result not provided) that showed extreme anemia. The patient also developed atrial flutter. Treatment for atrial flutter included cardiac ablation and apixaban.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, pericarditis and atrium flutter, was considered not recovered. The outcome of the events, anemia and night sweats was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of taking colchicine can be contributory to the Anemia.
My hyperthyroid symptoms appeared 10 days after my first Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "My hyperthyroid symptoms appeared 10 days after my first Pfizer vaccine". Additional information: patient's hyperthyroid symptoms appeared 10 days after first Pfizer vaccine. Patient had been trying to control that ever since.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt complained of Dizziness, stomach upset add. pt's brother had same type of vaccines TDAP and MENACTRA with same lot #, but pt's brother fainted and was admitted to hospital.
Pt received the vaccine on 08 March she  felt tired and like her heart was racing dizzy  and her face was red within 2 hours after receiving the vaccine. 1400 8 March pt left work to relax, she felt tired, sluggish and had a Headache.  09 March Pt stil felt tired,  had a headache, body aches so she took the day off to rest. Pt had no fever but took Tylenol and motrin for the bodyaches.  10 Mar 2021- Pt reported to work at 0700 she still had an headache, took her blood pressure and it was 201/102, pt was transported to ED for treatment. At ED pt blood pressure was brought down 170/89, pt still had headache but was released on 10 Mar 2021. 11 March 2021: Pt reported for PCP follow up, pt still had a headache, BP was 180/120. Pt was sent to ED. Pt still had a headache Blood pressure was 169/90 pt was treated and still sent home.
he went and had an antibody test because he had no side effects and the results were negative; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 06Jan2021 (first dose) at single dose; and via unspecified route of administration on 27Jan2021 (second dose) at single dose; for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that he went and had an antibody test because he had no side effects to the vaccine and the results were negative on an unspecified date. He was asking what that means. His wife who was a health worker had side effects of chills and swollen arm. Outcome of event was unknown.  Information about lot/ batch number has been requested.
Saturday 12/19 early am, sore shoulder when rolled onto in sleep.  HA through out day Sunday  12/20 quarter size red area surrounding shot Monday 12/21 knot at site of injection that others could feel through my shirt-painful.  Swollen left arm pit but no distinct lymph nodes felt.  Arm pit tender when palpated. Tuesday 12/22 arm pit swelling remains as well as knot at site and pain when either or both palpated.
vomiting, paleness, listlessness occurring approx 2 hrs p/vax were administered; vomiting cont through evening; paleness, listlessness lasted a few hrs; pt fine next AM;