chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect; The patient was vaccinated with improperly stored vaccines.; This spontaneous report was received from a nurse referring to patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 16-MAR-2020 at 15:33 , the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot# S023219, expiration date on 03-MAR-2022, 0.5 milliliter, intramuscular in the left thigh, and with  diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) with lot # YS4Z5 and expiration date was unknown, 0.5 milliliter, intramuscular in the right thigh, and pneumococcal 13v conj vaccine (crm197)(manufacturer unknown) with lot # AT8585 and expiration date was unknown, 0.5 milliliter, intramuscular in the left thigh all vaccines for prophylaxis      Administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects reported. The temperarure excursion was no reported for the other vaccine.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008879: US-009507513-2008USA008882: US-009507513-2008USA008878: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Tested positive for Covid-19 on 7/7/22; saw telenurse 7/9/22 - prescribed Paxlovid; tested negative on 7/18/22. Isolated for 7 days after testing negative.   Fever of 102 for 3 days, muscle ache, mild cough, ?brain fog?.
little bit of difficulty catching breath, heart beat became rapid for a short period, experienced cold tingling feeling in chest
Patient is receiving second Moderna vaccine after six week period.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving second Moderna vaccine after six week period.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving second Moderna vaccine after six week period.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving second Moderna vaccine after six week period.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Tinnitis in both ears. Not sure when it started but started noticing it a few days ago.
Severe weakness dizziness joint pain body ache muscle weak. After four days went to MD. Today my joints and muscle remain weak and painful.
The person was vaccinated with their first COVID-19 vaccine, which was Moderna.  This was at a walk-through point dispensing site.  A few hours later on the same day the person was vaccinated at a mobile site that provided the Pfizer vaccine.
This spontaneous report as received from a physician and registered nurse refers to a 12 month old patient of unknown gender. On 29-DEC-2014 the patient was accidentally vaccinated with a dose of ZOSTAVAX (lot# and dose/frequency were not reported), subcutaneous instead of VARIVAX (Merck) due to a human error. And the patient also received M-M-R and FLUZONE on the same day on 29-DEC-2014. No adverse effect reported. This was one of two cases reported from the same source. Additional information has been requested.
At almost exactly 24 hours after the shot my arm starting hurting badly on 01-08. That night I woke up with my arm swollen to about 3 times its normal size with intense pain. I called the pharmacy that gave the shot and they said to get to a doctor or ER right away. Dr got me in and said I was having a reaction. Prescribed benadryl and steroids. These initially helped the pain but the swelling never went all the way down. My arm is still swollen and painful
COVID-19/runny nose/congestion; developed allergic reaction to peanuts (and tree nuts, sesame); I am fully vaccinated and was nursing him; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 15 month-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID-19/runny nose/congestion"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "developed allergic reaction to peanuts (and tree nuts, sesame)"; EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "I am fully vaccinated and was nursing him". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Mother was fully vaccinated and was nursing him. Patient did not receive any Pfizer medication or vaccine. He has since developed allergic reaction to peanuts (and tree nuts, sesame) even though he did not have allergies with repeated prior exposure. Allergy was confirmed at allergist office with skin test performed 08Feb2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200239715 Mother case
At 1000 hours the employee reported to the office.  Due to having reactions to other vaccinations in the past the employee was cleared by her primary provider to receive the Covid vaccination. At approximately 1015 on 09/16/21 the patient was administered Janssen vaccine. At approximately 1200 the patient called the office to report feeling tired, arm pain and feeling warm. Patient was asked to report to the office for an assessment. During the assessment the employee reported feeling new onset congestion and tightness at the top of her chest. Vital signs SpO2 98%, 98.5F, 115/80 BP, 87 pulse. Emergency number was called at approximately 1236. Patient refused medical transport to the emergency room. Patient reported she was going to a clinic for treatment.
Notice about 3 days after vaccine large painful lump in Left breast.  By day 5 it was bigger and very painful.  The lump took over a week to soften and go away.  I am still tender with some swelling in the arm pit lymph notes.
On 5/2/01 PM, red area around injection site (4" around). At 03:00 AM, awoke complaining of pain to left leg and it was still red. Temperature was 99.6F. On 5/3/01 at 09:00, went to health dept with left leg very swollen, red, hot to touch, discomfort to touch, blue to purple color (area of injection) and skin felt thickened. Referred to MD. Dx'd with cellulitis. Temperature of 99F. Medications given were Omnicef 125mg 5ml (2 tsp) daily x 6 days therapy; prednisolone 150mg 1/1 tsp twice a day x 5 days. On 5/4/01, improvement of 25% or more, less swelling and red coloring was lightened. On 5/7/01, slight purple color about nickel-sized, no pain and no swelling. No fever; almost gone. Information from grandmother.
within minutes of being vaccinated, developed feelings of swollen lymph nodes, fullness and stiffness in her neck. She has redness across her upper chest. She has experienced side effects similar to this from other vaccines she's received in the past.  She was observed in the ED but no medications were administered. Her symptoms improved and she was discharged with a prescription for an EpiPen and an appointment to follow up with an allergist.
AE- sore arm for 36 hours and a headache for about 2 days. I did not have fever. 04/25/2022 - I started feeling sick, sore throat, then I had a barking sort of cough, but it was productive, originally was clear and then started getting yellowish-tint. Loss of sense of smell. Pain in my left maxillary  sinus and frontal sinus. The symptoms prompted me to take a COVID-19. I took a home test, one in the morning BinaxNow was negative. I did Flo fax at home that night- negative. I took the PCR test-04/27/2022, I got the results, 04/28/2022- it was positive. I talked to the nurse, given my diagnosis, I was given Paxlovid- 4/28/2022, I started it on late afternoon. I am not totally better, but I am feeling better than 2 days. I have noticed overwhelming tiredness. I have been sleeping for like 10 hours and I never sleep for 10 hours. Unknown because I noticed I was feeling better one night and I was feeling worse when I woke up. I have also noticed I am more short of breath than I usually am. I am getting better.
11/11/21 presents to FBC "with c/o ctx q 5minutes". PMH "HPV infection"
This case was reported by a physician via call center representative and described the occurrence of foggy feeling in head in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included celiac disease. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced foggy feeling in head, myalgia and pain. On an unknown date, the outcome of the foggy feeling in head, myalgia and pain were unknown. It was unknown if the reporter considered the foggy feeling in head, myalgia and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician was a gastroenterologist. The healthcare professional reported that patient got some symptoms similar to gluten exposure (foggy head, aches and myalgia). The patient received the dose at her primary care office. This information was collected via chat so this was all the information that was provided.
Fever achy chills exhaustion queasy headaches injection site is hard and bruised red and swollen below injection site
chest pain , lightheaded and palpitations .  felt flushed and dizzy about 1 min after vaccination.  felt better after observatrion
Rash start 1 day after vaccination of Td and PPD.  (+) Rash on facial, right deltoid and trunk.  Treatment: Benadryl 25mg by mouth as occasion requires.
BRAIN FOG; DARK AND SWOLLEN ARM PITS; FOGGY VISION; MUSCLE CRAMPS; DARK ARMPIT; JOINT PAIN; MUSCLE WEAKNESS; MUSCLE PAIN; FATIGUE; RINGING IN EAR; TINGLING IN FEET; BUMP WITH FLUID, THAT LEFT A MARK; This spontaneous report received from a physician concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain due to trauma, hyperlipidemia, copd, hypertension, obesity, and carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine besilate for drug used for unknown indication, atorvastatin calcium for drug used for unknown indication, clopidogrel bisulfate for drug used for unknown indication, glyceryl trinitrate for drug used for unknown indication, lisinopril for drug used for unknown indication, metoprolol for drug used for unknown indication, tiotropium bromide for drug used for unknown indication, and tramadol for drug used for unknown indication. On 11-MAR-2021, the patient experienced bump with fluid, that left a mark. On 12-MAR-2021, the patient experienced brain fog, dark and swollen arm pits, foggy vision, muscle cramps, dark armpit, joint pain, muscle weakness, muscle pain, fatigue, ringing in ear, and tingling in feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump with fluid, that left a mark, muscle pain, joint pain, fatigue, ringing in ear, muscle cramps, muscle weakness, tingling in feet, brain fog, dark and swollen arm pits, foggy vision and dark armpit was not reported. This report was non-serious.
Patient received a bivalent booster instead of monovalent first dose. No adverse effects noted.
Got a fever after 48 hours of receiving the shot.  Baby got an armpit reading of 102.5 and was feverish for 48 hours, afterwards did not eat/drink for 24 hours.
2 days after receiving flu vaccine in clinic, pt developed cellulitis at site which was diagnosed by pt's PCP.
Pain all over body; Mouth pain; Very pale complexion; Headaches; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 08Jun2021 at 19:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On an unknown date in Jun2021, the patient experienced pain all over body, exhaustion, headaches, mouth pain and very pale complexion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. On 05Jul2021, the patient underwent COVID test and the result was negative. The clinical outcome of the events pain all over body, exhaustion, headaches, mouth pain and very pale complexion was not resolved at the time of this report.
Patient returned to pharmacy complaining that she was itchy all over. Gave 25mg liquid BENADRYL. Took BP 130/76. Sat with patient and explained symptoms of anaphylaxis. Advised ER for observation. Itching decreased. Pt left with spouse and promised to stay in town near hospital for at least an hour. Called pt at home at 3:15 pm and itch was gone complained of sore arm and tired legs but said was fine otherwise.
Breakthrough case admission after 3 vaccines Moderna 1/25/21 Lot# 004M20A;  Moderna 2/22/21 Lot# 023M20A;  Moderna 10/22/21 Lot# 076C21A
About 4-5 hours after shot had pain in arm shot was given. Next day had chills, body aches, fatigue, and could not move arm without having severe pain. On the second day after vaccine, woke up with entire upper arm red and some swelling and very hot to the touch. Went to Urgent Care and as told it was cellulitis caused by a severe allergic reaction to the vaccine. Given a shot of clindamycin and also clindamycin 300 mg by mouth three times a day.
Pediarix instead of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 details were provided as follows: The patient was administered a dose of Pediarix instead of Kinrix, which led to wrong vaccine administered. The reporter consented to follow up.
Information has been received from an office manager concerning a pt with no medical history and no allergies who on 03/02/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N). There was no concomitant medication. Subsequently, the pt developed swelling, redness and hot to touch at the injection site. No medical attention was sought and no diagnostic studies were performed. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N) and developed swelling, redness and hot to touch at the injection site (WAES # 0403USA00640 & 0404USA02543).  Additional information has been requested.
Though I (reporter) had Covid vaccine, I did not feel well, the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Covid 19, for covid 19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Though I (reporter) had Covid vaccine, I did not feel well, the second dose".  Additional Information: Patient (reporter) had Covid vaccine, She did not feel well, the second dose, She took vitamin C and Vitamin D and all, She was fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: 11122) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID 19 Treatment with Paxlovid. Treatment start date was 23Jul2022 and stop date was 26Jul2022, Indication: Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Covid 19 and Drug Ineffective and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
No adverse effect; One patient received one dose of PROQUAD that was improperly stored; This spontaneous report was received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. Concomitant therapy included sterile diluent.     On 13-AUG-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003868 (expiration date: 08-AUG-2020) for prophylaxis (route and dosage details were not reported) (product storage error). Diluent (unknown lot number and expiration date) used to reconstitute was stored properly. The vaccine was stored at a temperature of -13.4 Celsius (C) for a time frame of 2 hours. There was no previous temperature excursion reported. The call was because of a data logger. The patient did not experience any adverse effects. No product quality complaint (PQC) was involved.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 30-MAY-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
A 6 year old female pt experienced fever and vomiting while receiving RabAvert for post exposure prophylaxis. The pt received RabAvert 1.0ml on 15Jul04, 18Jul04, and 29Jul04. Past medical history was not provided. The child received no concomitant medications. In the evening following the last two doses of RabAvert on 22Jul04 and 29Jul04, the pt developed a temp to 102 F and vomiting lasting about 18 hrs. No specific treatment was stated. The physician reporter planned on giving a fifth dose of RabAvert on 12Aug04. The events were considered resolved.
Hospitalized with dyspnea, tachycardia, and rash in patient with recent bone marrow transplant.
Narrative:  COVID infection following COVID vaccine series 02/23, Pfizer dose #1 03/16, Pfizer, dose #2 09/02, Pfizer, dose #3 12/30 COVID swab, result detected 1/10 COVID swab, result: detected 12/27 pt cc: cough, rhinorrhea, exposure: unknown 1/10 TROPONIN I: <0.016 1/10 ESR: 20 1/10 CXR IMPRESSION: No acute abnormality.
I did not have any complications after receiving my Moderna Dose 4 vaccine. I tested positive for COVID-19 on 04/14/2023. I only had two symptoms with COVID-19, fever and coughing. I went to my doctor and got a prescription for an antibiotic for an infection in my chest and for cough. As of today, I feel better with no lingering symptoms.