chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness and soreness at injection site and 2 days later swelling, redness and pain throughout upper arm muscle.  The pain extended down my arm even to my hand. It was very painful to move my arm. It is still sore, red and some lingering pain in my upper atm muscle today (1 week and 1 day after receiving the shot).
pt recv vax 12OCT96 & arm was tender to touch w/tired feeling in arm;pt exp pain w/& w/o use of the arm sometimes radiating to the elbow & to the neck & shoulder;As of 4FEB97 only has pain w/a sudden or unexpected movement;
Information has been received from an RN concerning a 24 year old female who was a medical intern. On 12/15/97 lot 0876E, 4/1/98 lot 0876E and 4/2/99 lot 1896H, the pt was vaccinated with the 1st, 2nd and 3rd doses of Hep-B. On 5/31/00, the pt was dx'd with active Hep-B. The pt sought unspecified medical attention. The reporter stated a concern regarding the lot. Also reported was a male intern (WAES 00060272) who was vaccinated and developed a similar event. Additional information has been requested.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: She states that the symptoms started on 3/13/23 the night of her immunization, and the itchiness is getting better now but the redness it still there and she is still lethargic.
fever; Nausea; Loss of appetite; Dry heaves; Still feeling weak; Chills; Arms spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arms spasms), DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves), ASTHENIA (Still feeling weak) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MUSCLE SPASMS (Arms spasms), ASTHENIA (Still feeling weak) and CHILLS (Chills). On 26-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves) and NAUSEA (Nausea). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Arms spasms), DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves), CHILLS (Chills) and NAUSEA (Nausea) was resolving and ASTHENIA (Still feeling weak) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Follow up received and contains no new information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea  and chills are consistent with the known safety profile of mRNA-1273.
Pneumonia vaccine given to pt who is a nurse on 11/20/07. Pt had some tenderness that evening more tenderness the following morning. 11/22/07 in the morning pt developed low grade fever with redness around injection site. By 11/23/07 redness spread to entire arm, temp of 102.6 and arm so tender pt could not lift arm. Pt taken to er, given antibiotics and sent home with diagnosis of cellulitis due to pneumovac
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose number, route, lot number and expiry date unknown). On an unknown date the patient developed swelling at the injection site after administration of PNEUMOVAX 23. Patient sought medical attention. The outcome of swelling at the injection site was unknown. No further information provided. Additional information is not expected.
Site: Pain at Injection Site-Severe, Systemic: swelling on wrist-Medium, Additional Details: pt had pain and swelling of arm. She went to a HCF.  We called to see how pt was that evening.  We will follow up with patient again tomorrow am.
Symptoms:  Heart pressure/pounding (pain?) starting 7 Dec around 7 PM, same continuing occasional (short periods--minutes) occurrences since (10 Dec 2021: 10:35 AM).  No shortness of breath or fatigue.  No treatment to date.
Fever 100.5  Pt also ran fever after dose given on 02/28/2020, but thought may have been due to Pentacel.  Tried to space out vaccines and start with PVC 13 on 4/29/2020, but ran fever later in evening following vaccine.
Systemic Allergic Reaction: mom called, symptoms began with swelling of lips, ears, hands, fingers, wheezing. Mom was advised to bring patient to ER, mom declined , came to office. By the time the patient arrived at the office at 11:40 am, he had welts, grunting while breathing, very swollen bottom lip, ears, rash on extremities, poor peripheral perfusion, unable to speak, not moving air well. Pt was immediately brought back to exam room, vitals taken, provider entered room to assess, was given Epi 1:1000  0.2cc IM Left lateral thigh at 11:44am. Started Albuterol neb 0.083% at 11:47 am. Vitals reassessed every 5 minutes, were stable throughout other than the normal side effects of EPI (shaky, Tachycardia) and Albuterol (Tachy and shaky). Pt was kept in office for 2 hrs to ensure reaction did not reoccur once medications wore off. RX for Epi pen JR called into pharmacy, educated mom on the seriousness of allergic reaction. Allergist contacted to ensure patient gets appointment.
Pain and mild swelling at injection site, extremely achy, fatigue, headache, gastric upset.
COVID-19; COVID-19 pneumonia; lost of taste and smell; lost of taste and smell; fever; cough; difficulty breathing; body aches; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3893794-00.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 06Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (hospitalization, medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; COVID-19 PNEUMONIA (non-serious), outcome "not recovered"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell"; PYREXIA (non-serious), outcome "unknown", described as "fever"; COUGH (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; PAIN (non-serious), outcome "unknown", described as "body aches". The patient was hospitalized for covid-19 (start date: Dec2021). The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (Dec2021) Positive.The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Doctor office called to report child seem 1 day after Varicella vaccine received, s/s increase WBC, reddened area 2 x 2 at injection site. Mom states child not feeling right all the time, c/o fever, seen by doctor Friday, Saturday, Sunday, Monday. Received Keflex PO without results. Received Decadron and site cleared and now c/o runny nose, clear, cold like symptoms on day 5 and 6. Doctor x allergic/ adverse reaction to vaccine.
POST VACCINATION SHOT- APPROX. 17 MINUTES-  C/O FRONTAL AND TEMPORAL HEADACHE (4:10 PAIN SCALE LEVEL).  DOES NOT USUALLY GET A HEADACHE.  DENIES ANY OTHER COMPLAINTS AT THIS TIME.    EMS AND RN ON SCENE, ASSESSMENT MADE . 0957:  VS:   BP:  111/76;  P:  79; 02 SAT:  97 % ON ROOM AIR; 1003:  VS:  BP:  110/78; P:  77; 02 SAT:   96% ON ROOM AIR.
Became nauseated, dizzy and had muscle weakness.  Next morning 10/30 continued to have severe muscle weakness, greater on L side of body.  Went to ER.  All tests WNL.  Went home prior to recommended overnight stay for stress test.  No diagnosis made at ER.  Muscle weakness continues to date.  Personal physician retired and has appt. with new doctor on 11/17.
Mother states child began to run a fever of 103.5 x 4 days. Mother relates they were out of town. They left that evening post child was immunized. The fever began in the evening same day that immunization was given. She took child to ED. On the 5th day post the immunization was given the child had a rash x 3-4 days. She returned home with child and was seen at clinic by Dr. He told her to report to health dept. Dr. related that it could have been a reaction to Prevnar.
Reports that he had pain at the site of injection X2 days; Noted chills and body aches for 2 days
Vomiting weakness extreme ear ringing severe shaking of head and hands severe cramps in calves and hands headache near syncope constantly high heart rate numb hands nausea
Severe shoulder pain that has persisted past the point of normal injection site soreness and has restricted movement.
This pt received MMR and one week post vax, experienced lymphadenopathy of the neck, submandibular and suboccipital regions. Additional information has been requested.
FEVER ON AND OFF ( EXTREMELY ANNOYING); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose series 1) for prophylactic vaccination (route of administration, batch number and therapy date not reported). No adverse events associated with dose series 1.    The patient received covid-19 vaccine ad26.cov2.s (dose series 2, manufacturer not specified) (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, the patient experienced fever on and off (extremely annoying) for 5 days (dose series 2) .  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from fever on and off (extremely annoying).  This report was non-serious.
no adverse effects; improperly stored PROQUAD; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not provided.  On 02-JUL-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number R024015 with expiration date on 19-FEB-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion between 6 up to 14 degrees Fahrenheit (12 F) degrees Fahrenheit for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004719: US-009507513-1907USA004800:
Pt. developed tachycardia, hypertension and felt weak with decreased verbal responsiveness, alert but lethargic. She complained of dry throat, took a sip of water then began persistent coughing and wretching also C/O itching of her throat. She denied difficulty breathing, there were no cutaneous signs of edema, tongue enlargement, etc.
Localized dermatitis reaction to injection site on (L) upper arm. Onset 48 degrees after injection. Reactoin not classified as severe and requiring minimal office visit with provider ordered tx.
A report has been received from a health professional concerning a 9 month old, subject of unknown gender, who had been receiving FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on an unknown date. The reporter stated that the patient experienced administered FLUMIST Quadrivalent to a 9 month old. The outcome of the event of administered FLUMIST Quadrivalent to a 9 month old is unknown. The report was considered to be non-serious by the reporter.
Spondylolisthesis - Procedures: Lumbar2-Lumbar3, Lumbar3-Lumbar4, Lumbar 4- Lumbar 5, Lumbar 5 - Sacrum 1 Transforaminal lumbar interbody fusion. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Had a breakthrough of COVID which lead to blood clots in my lungs. 8 blood clots was removed from my lungs in surgery.
Pt developed left-sided facial numbness and LUE numbness within an hour of vaccination, but not within the 15-minute post-vaccination waiting period. Physical exam remarkable for decreased sensation of left face, neck and LUE. No motor deficits and remainder of neurological exam normal. Concern for complex migraine due to migraine hx vs TIA vs stroke. Pt sent to ED for further evaluation. Had Head CT, EKG, labwork done in ED, all of which was normal. Pt was told vaccine likely triggered migraine. She was discharged home from ED on same day, and symptoms resolved same-day. No residual symptoms the following day, 14 Jan 2021.
Patient's father called through the answering service to report that patient had vomited several times and had fever of 104 on the evening of him receiving his 3rd Gardasil vaccine. The following day patient was examined and found to have splenomegaly and on US and CT he was noted to have a large hematoma that appears to be spontaneous as there is no history of trauma. He was transferred from ER to another hospital's ICU where surgery and hematology were consulted. He was admitted 6-14-13 and discharged 6-19-13. No additional treatment was needed.
Aches, chills, low grade fever, headache, fatigue 72 hours later, redness in arm with warmth and swelling and pain
Telephone report received on January 23, 2001, regarding adverse events possibly associated with administration of Fluvirin.  A wife reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks after receiving a Fluvirin vaccination at a local VA Clinic.  He was then prescribed "Lasix (ferosemide) for his heart, Coumadin (wafarin sodium) for his blood, Prednisone (Prednisolone) for his PMR, and Synthorid (thyroxine sodium) for his thyroid".  He had previously been on no medications and had no medical problems.  He has received flu shots in the past, without problems.  This symptoms manifested as "achiness in his hips, thighs, and calves".  He normally works out at a club three times per week, but has not yet been able to resume that activity. Follow up information received April 24th, 2001;  Physician identified as primary care provider wrote:  "I did not administer a flu shot to this patient".  No further information is expected. Additional information received on June 5, 2001, from treating Rheumatologist.  The day after receiving the flu vaccine, the patient woke up with severe pain in thighs, calves, and hips.  A few days later, joint pain began.  This patient also had fevers to 102 and lost 22 pounds.  The family doctor started him on Prednisone, Plaquenil, and NSAID's with good effect.  As of 05/21/2001, his positive RF has persisted.  Rheumatologist now believes "this patient has chronic sero+ RA".  Hand x-rays to look for pattern of erosion have been taken; results are pending at this time. (OMIC)
fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: EW0162) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "stage I breast cancer" (unspecified if ongoing), notes: she had stage I breast cancer 10 years ago; "mastectomy" (unspecified if ongoing), notes: She had a mastectomy done. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200699539 same patient, same product, different dose, different events;US-PFIZER INC-202200700343 same patient, same product, different dose, different events
About 6 hrs pt broke out rash, itching, advised, per Dr. take Benadryl as directed.
Estimated due date: 5/31/1986. Around December 1985 I called to say I was sick. They couldn't get me in until January 1986. By then the stomach virus symptoms subsided, but I had extreme leg and hand/arm weakness. I was falling down and dropping things. I was finally admitted after several appointments and referrals to chiropractic care, unable to walk or lift arms. Later that week I was diagnosed with Guillain Barre Syndrome. I delivered baby. He weighed 8.1 lbs. I was sent to Rehabilitation Center, in June until August 1986. Without my baby. I had extensive physical and occupational therapy and discharged myself against medical advice to go home to babies. I went to outpatient PT from August 1986 through August 1988? Wheelchair bound. I still go through PT, acquainted therapy, gait training occasionally. I've used a cane now since, for gait issues and balance. I have gotten weaker recent years and saw Dr again in 2015. Dx: post-polio syndrome. I am still under care for pain management.
pain, ache behind his right eye, that is still there fuzzy vision that lasted for 30 minutes warmth on top of head and around his ear
local erythema, tenderness, swelling after 24h, then fever tmax 101.5
developed sx and tested positive on abbott id now molecular test 9/9/2022 has completed primary series plus 1 booster- all pfizer- due for covalent booster
I became extremely ill about 12 hours after vaccination.   I slept about (10pm to 6:30 am) 8.5 hours, and then I  woke for work the next morning.  I felt a little off, but I thought I was ok.  I entered my shower, and then I was found unconscious on the floor of my shower by my wife about 5 minutes later.  I passed out 2 more times while attempting to stand and exit the shower.  I was extremely fatigued at this point.  I went back to bed and slept until 10 pm that night.  I woke for about 2 hours , ate  some food and drank some water and soda pop.  I then went back to sleep until 7:30 am  the next morning.   I was awake for 3 hours, and then I slept for 3 more hours.  I have been awake for about 2 hours, and I am now typing this adverse event document.   The entire time I have had temperature regulation issues, severe headache, muscle and joint aches, and fatigue.
This is an initial spontaneous report from a Pfizer Sales representative reporting on behalf of the contactable Physician for a patient. This 56 year old female patient receivd PREVNAR 13 since an unknown date at an unknown dose and frequency. Relevant medical history and relevant concomitant medication was unkonwn. Since an unknown date the patient experienced localized reaction after three days of injection  while on PREVNAR 13. Relevant laboratory data was unknown. Last action taken with PREVNAR 13 therapy was unknown. Therapeutic measures taken in response to the event were unknown. Clinical outcome of the event was unknown at the time of report. Follow-up (30Jan2014): Follow-up attempts completed. No further information expected.
About 45 minutes after the vaccineI left I literally felt very shakey, heart racing. About 6:30 pm I got really nauseated and vomited for about 15 minutes straight ( it was horrible). About minutes after that I vomited again until I had dry heaves. Woke up at 5:08 a.m. to a horrible headache and a low grade fever. Finally started feeling better about 6:00 p.m. the next evening.
pneumonia date of vaccination (yearly); No adverse event; This spontaneous report was received from lawyer an elderly male patient, concerning to himself via a plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2108USA002039). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). It was reported that another doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") was administered yearly (inappropriate schedule of product administration). No adverse reaction or side effects experienced.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2108USA002039:
headache for 2 days, joint pain: mostly shoulders 2 days,   2 days after getting vaccination got a full body rash that lasted 2.5 days
First, I was given the high-dose flu vaccine (they said it was for over age 50) at the same time as the SHINGRIX vaccine, so I'm not sure if my side effects were due to an interaction, etc. That said, my Sx were extreme fatigue (starting about 10:30 am and  lasting 3-4 days), but the worst AEs started about 2:00 pm that day, and included dizziness (couldn't sit up), tingling/numbness and shakiness in hands, sweating/hot feeling (but no fever), heavy chest, fast/hard heartbeat - all of which lasted about 3 hours.. I was never warned that I could experience these (or any) side effects, and so I called the nurse, and she said these were all expected side effects and that I should only worry if I got a rash around the injection site. I feel like these were pretty severe, not to mention scary, and worth reporting.
severe ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (severe ear pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 033C21A and 007B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced EAR PAIN (severe ear pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, EAR PAIN (severe ear pain) outcome was unknown.            Concomitant medications included antidepressants. PCP prescribed gabapentin and diphenhydramine. .   This case was linked to MOD-2022-451567 (Patient Link).
When I first received the vaccine, it was very painful. I developed hives a few days after the vaccine. I went to the urgent care and I was given a shot and prescribed cortisol. I went to the allergy specialist and was prescribed Zyrtec on August 4th, 2021.