chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever started 24 hours after shot was administered and lasted for 48 hours. Itching persisted for 48 hours. Unusual muscle contractions for 48 hours along with Insomnia.  Headache, nausea and fatigue for 48 hours. Lymph nodes under the arms, breast tissue,  left side of neck and  bilaterally in groin became swollen and   painful and is still persisting  after 4 days. I also experienced brain fog, pain in right pelvic region and onset of early period. in addition breasts increased in size and became painful to touch.
(R) upper arm swollen approx 6x3 inches in diameter, warm to touch, erythematous. Rx: PO BENADRYL 25 mg 1 hs qd to BID PRN allergy/itching. Instructed if increase in size, go to ER - MD office.
A nurse reported that a pt received an injection of Pnu-Imune 23 in 12/00. Subsequently, the pt developed an injection site reaction characterized by redness, swelling and warmth extending from shoulder to elbow. The symptoms resolved within 72 hours. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
11 days post vaccine - rash on trunk. 15 days post vaccine - stiff, sore joints in knees, feet and Lt wrist.
axillary lymphadenopathy lt axilla;T to 101, erythema, swelling @ inj site;PE w/tender adenopathy lt axilla 5x5cm red, induration @ vax site;
Headache; Muscles aches; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, single (Lot number: EN5318) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Viral cardiomyopathy" (unspecified if ongoing); "Congestive heart failure" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EL1283, Time: morning, probably 11 AM), administration date: 17Jan2021, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscles aches".  Clinical course: Asthma Medications: Spiriva 1.2mcg per spray. 1 spray in morning and 1 in evening. Alvesco:160 mcg per spray. 1 spray in morning and 1 in evening. Albuterol rescue inhaler, which she generally doesn't take, but did take during that time because of the breathing difficulties. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations: Headache and muscles aches most with second COVID-19 Vaccine.
PATIENT WAS SEATED IN POST IMMUNIZATION AREA AND PASSED OUT AND FELL TO FLOOR, BECAMSE RESPONSIVE AFTER 30 SECONDS AND PARAMEDICS CLEARED HER TO GO.
I developed one lump on the upper outer quadrant of my left breast and two under my left arm that were very painful. I called and made an appointment to see my doctor. She did examine me and scheduled an ultrasound. I currently do not have the same pain, but the lumps are still present.
Pt. was given TDaP 5/1/17. Redness to area of (R) deltoid hours after adm. which progressed to an extensive area of induration which appeared to an extensive area of induration which appeared to be cellulitis. NP was consulted. U/S of (R) arm done which was (-). Cellulitis Dx. KEFLEX x 10 days.
painful blistering; rash; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On 06-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) administered at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the pt was treated by a health care provider (HCP) for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX)use: painful blistering and rashes. The outcome of the claimed events was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain on deep inspiration. Patient has a PMHx of anxiety which they believe instigated the side effects. Patient was transported via EMS to hospital with non-urgent acuity.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 13-AUG-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Patient is a 82 y.o. male presenting with shortness of breath and nausea and vomiting. Patient has a past medical history of bladder cancer, COPD on no home oxygen, hypertension, chronic UTI, BPH, and Pfizer vaccination from COVID-19 on 1/4/21 and 2/5/21. Patient was symptomatic with shortness of breath and nausea and vomiting since 07/13/2021.  Patient went to urgent care and tested positive for COVID-19 on 07/19/2021. Patient went to the ER and received a fluid bolus as well as Zofran; the wife states that the Zofran does not help with the nausea and vomiting. At home, patient denies fever, muscle aches, chills, chest pain, abdominal pain. Patient admits chronic cough, chronic headache, and pain with urination, most likely due to BPH. Patient denies known history of sick contacts. COVID-19 pneumonia, tested positive 7/19/21, currently requiring 1-2 L of oxygen, baseline room air
per pt, has higher than normal blood pressure (175-95), elevated heart rate (did not give value) and rash on stomach; per pt, she treated herself with tylenol and benadryl  and issue resolved within 4-5 hours; pt says she is completely back to her "normal" today, but did want us to report
devel vomiting & severe diarrhea on 31OCT95;began to have diff standing & the sensation of wanting to jump out of skin;condition cont to worsen & pt seen by MD 21, 23 & 24NOV;24NOV pt was unable to stand & was adm to hosp;dx GBS
BELL's Palsy 2 weeks after MCV4 vaccine. Treated with Prednisone, Acyclovir.  4/29/09 MR received from PCP with DX: Bells Palsy.  Pt presented initially with onset of tongue numbness progressing to L sided facial droop. PE (+) L sided facial weakness and inability to fully close L eye. Tx:  Pred and anti-virals. Slight improvement noted by F/U 3/21/09.
Pt required vaccines on 7/25/12. Mom states (L) arm has been red, swollen and hot to the touch for 3 days. Advised to call PCP today and have child seen. Mom states child has discomfort.
bump on the arm/swelling on the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (bump on the arm/swelling on the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (bump on the arm/swelling on the arm). At the time of the report, VACCINATION SITE SWELLING (bump on the arm/swelling on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 29-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA002267: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
I woke up with massive edema and swelling in both of my arms. There was a slight redness and pitting to the arm. There was no other significant signs or symptoms. It appeared over night.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age patient (gender unknown) who received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication reported. 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. It was a case of actual medication error due to Wrong technique in product usage process. (Improper administration of PENTACEL to a customer). It was unknown whether patient experienced any adverse 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 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. Follow-up report received from an-other healthcare professional on 21-Aug-2018. No new information was reported. List of documents held by the sender: None.
got the virus after her first shot/ had a positive nasal swab COVID test; got the virus after her first shot/ had a positive nasal swab COVID test; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date in Mar2021 at 12AM (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated she got the virus after her first shot (reported as 28Mar2021 12:30). The patient had a positive nasal swab COVID test on 31Mar2021. The patient received the second dose of the vaccine on 13Apr2021. The outcome of got the virus after her first shot/ had a positive nasal swab COVID test was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457391 same patient and reporter, different dose and event
A week after injection (01/30/2021) I woke up with a red rash at injection site it was swollen,red, itchy,and painful. On 01/30/2021 I started taking ibuprofen  800 mg I took and benadryl. I had to change to chlorpheniramine since I can not function on benadryl. As of today (02/02/2021) I am still taking ibuprofen and chlorpheniramine it is getting better.
The patient was diagnosed with "an allergic reaction" to the vaccine or a component of it; The patient complained of "pain, tenderness, soreness at the injection site" the following day; This spontaneous report has been received from a pharmacist via company representative, concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and an unspecified allergy medication.  Approximately on an unknown date in June 2019 (reported as "last week"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R025297 (dose, frequency, route, anatomical location and expiration date were not provided) for prophylaxis.    Approximately on an unknown date in June 2019 (reported as "the following day"), the patient experienced pain, soreness, tenderness at the injection site (injection site pain). The reporter directed patient to her primary physician and the patient was diagnosed with an allergic reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) or a component of it (allergy to vaccine). The patient was treated with prednisone.  The outcome of allergy to vaccine and injection site pain was reported as resolved. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal relationship between injection site pain and the therapy was not assessed.
unconsolable crying lasted 2-3 hrs w/fussiness continuing until 10 hrs p/vax; phone call to physician;
no adverse effect; patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history or drug reactions/allergies. Concomitant therapies included sterile diluent.      On 08-JUL-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, frequency and route were not reported, lot # was S003170, expiration date was 30-JUL-2020) for prophylaxis (product storage error). The sterile diluent that was used to econstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. No adverse effects were reported.  There was no previous temperature excursion. The temperature and time frame was 15 Fahrenheit (F) to 46 F for 3 hours. It was not call because of a data logger.
Metallic taste right after for 45minutes 6 days post injection @12pm bp 130/101 resting hr94, @ 2:30 bp  141/100 resting hr 96 palpitations and SOB untill3:30pm then again from 5pm-6:30.  Diastolic has went down from the 80s and 90s but systolic has kept in the 140 range.  My normal is around 120/80.
Cold , fatigue, migraines, congestion, runny nose , irritable, confusion, falls
Adverse Event - temperature of 102, nausea and headache on PM of 12/30 Treatment - unknown Outcome - unknown
Pt stated she had a red line/mark that appeared the next day and it was traveling down her arm approximately 2 inches.  She had tried ibuprofen.
Information has been received from a pharmacist concerning a 65 year old female with no allergies who on 13-NOV-2007 received a 0.65 ml subcutaneous dose of ZOSTAVAX (lot# 658361/1090U). There was no concomitant medication. On 15-NOV-2007 she developed reddness at injection site and the area was hot to touch. The patient contacted the pharmacist. Further medical attention and/or treatment was not reported. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Four hours after receiving 2nd dose RABAVERT, increased pain at injection site, into shoulder and back, down to elbow. Eight hours after injection, chills and fever. Thirteen hours after injection she had nausea and vomiting which lasted for 4 hours. On 1/31, 30 hours after injection, aches, HA, no fever.
Fainted 10 minutes following administration of vaccine. Patient fell from chair, unconscious. I aroused him and he regained consciousness after about 1 to 2 minutes. Blood pressure check at that time was 89/43, pulse 59. Patient was able to speak, said he passed out, bumped his forehead and lip. I gave ice pack for head. EMS arrived after less than 10 minutes, check vital signs and forehead and lip condition. Blood pressure was too low, so EMS transported him to local hospital. Hospital gave 1 liter IV fluid, advised him to get second dose on time and discharged him same day.
The initial intradermal administration attempt did not result in a wheel. No physical adverse events occured. There was a successful second attempt by an expert in intradermal administration, and was done intradermally.
Pt received vaccine in deltoid while seated.  Pt stood up to move to a different chair.  About 1 minute after standing, patient had a syncopal episode from a standing position to a face-down position on the floor.  Pt was awake and alert by the time RN arrived a few seconds later.  EMS called.  Vitals within normal limits.  No visible trauma.  No complaints of neck/back pain.   Pt moved himself to seated position.  Vitals recorded again, WNL.  EMS arrived and assessed patient.  Parent declined EMS transport.  Patient left clinic with parent in stable condition.
slightly swollen at injection site; itchy at injection site; small rash on back of neck; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (small rash on back of neck), VACCINATION SITE SWELLING (slightly swollen at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 138124 and 138124) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity reaction, Hives, Penicillin allergy (which cause rash on use) since 1960, Drug allergy (which causes disorientation on use.) since 1990, Shellfish allergy (which cause itchy throat on use.) since 1980, Hypothyroidism since 1985, Pancreatitis since 2020, Constipation chronic since 2021, Curvature of spine since 2010 and Food allergy (allergic to chocolate which cause rash.) since 1965. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced RASH (small rash on back of neck). On 20-Sep-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen at injection site) and VACCINATION SITE PRURITUS (itchy at injection site). On 25-Sep-2021, RASH (small rash on back of neck) had resolved. At the time of the report, VACCINATION SITE SWELLING (slightly swollen at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.   This case was linked to MOD-2021-304188 (Patient Link).
Mesenteric adenitis.  Started with mild abdominal pain and decreased appetite 24 hours after injection.  Awoke day 3 with severe abdominal pain and sleep disturbance.  Went to ED on day 3 for further evaluation.  Blood, urine, and abdominal ultrasound were reported within normal limits.  Pain persisted.  On day 6 patient was reevaluated at pcp office.  Abdominal xray reported normal.  CT of abdomen and pelvis obtained which was interpreted as positive for mesenteric adenitis.
Pt. states that after receiving the 1st dose of J&J 08/15/2021, started experiencing symptoms immediately of joint pain, right foot pain, agitation of Fibromyalgia, right ankle swelling, and bumpiness. Primary visit 08/18/2021, Ultrasound preformed (Blood Clot found under knee), several other blood clots found behind the calf area. Recommendation for blood thinners x 3 months. Scheduled for follow-up 08/30/2021 Ultrasound.
Continued reduction in stamina; with a few lingering covid headaches; almost as bad a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Continued reduction in stamina), HEADACHE (with a few lingering covid headaches) and VACCINATION COMPLICATION (almost as bad a reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Shingles. Concomitant products included GABAPENTIN for Shingles.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Continued reduction in stamina), HEADACHE (with a few lingering covid headaches) and VACCINATION COMPLICATION (almost as bad a reaction). At the time of the report, ASTHENIA (Continued reduction in stamina) and HEADACHE (with a few lingering covid headaches) outcome was unknown and VACCINATION COMPLICATION (almost as bad a reaction) had resolved.            No treatment medications were provided.   This case was linked to MOD-2021-033351 (Patient Link).
Many months after pt received her Varicella vaccine she appeared to have gotten Shingles. Was seen in pediatric urgent care and by myself for the rash concerns. Also consulted Pediatric dermatology at Hospital.
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was very painful) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported.On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was very painful). At the time of the report, PAIN IN EXTREMITY (Arm was very painful) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant mediation were reported. No treatment drug were reported.This case was linked to MOD-2021-388352, MOD-2021-388405 (Patient Link).