chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning around my R breast where there is an implant. This burning was INTENSE and lasted 5 days after my 2nd shot.; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 39-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration on 09Jan2021 at 09:00 am (at the age of 39-years-old) on left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included citalopram (CITALOPRAM), cyanocobalamin (VIT B12), ergocalciferol (VIT D), ascorbic acid (VIT C). The patient previously took first dose of BNT162B2 (Lot number: EH9899, Expiry date: unknown) on 19Dec2020 at 09:00 am (at the age of 39-years-old) on left arm at single dose for covid-19 immunisation. The patient stated that, burning around my r breast where there is an implant. this burning was intense and lasted 5 days after my 2nd shot on 10Jan2021 at 09:00 am. The patient recovered from the event burning around my r breast where there is an implant on 14Jan2021. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the adverse event.
No adverse effects noted. Resident received expired modern vaccine, expired on 10/13/2021
Redness, tenderness (3X3cm) (L) upper arm at vaccine site.
On 1/18/2021, the site of the vaccine had a small lump and was itching a lot. Then at night, the rest of the body (arms, legs, thighs) were itching a lot so I took Zyrtec.
Pt exp diarrhea, abd cramps, hot flashes, h/a & prolonged vomiting 2 hrs p/recvd 1st dose of Hep B vax on 26AUG91; The following day pt recovered;
Presented to receive flu vaccine being offered by clinic. Allergies were identified as well as previous local reaction to vaccines. No known allergies to vaccine components. Denied anaphylactic reaction previously. No autoimmune diseased noted, or other contraindications. Vaccine administered in deltoid, at approximately 0847. Administering technician notified of reaction approx. 0855, Pt evaluated. Pt was unable to speak, wheezing, gasping/gulping for air, pulse was steady and regular. Skin warm and dry. Pt was alert and oriented, communicated through head gestures. Affirmed sense of 'Impending doom.' Tongue was notably enlarged. EMS was activated. Prelocal protocol an Epi-Pen auto injection was administered to lateral thigh at 0857. O2 was administered at 15lpm via NRB. 0900, reassessed pt. Breathing easier, pulse was more rapid. Able to answer with 1-2 word answers. Fire Department on scene at 0902. Vital taken and stable/as expected after medication.
sinus; heat in right nostril; achy; nauseous; heat in right eye; dry heaves; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL SENSATION IN EYE (heat in right eye), RETCHING (dry heaves), SINUSITIS, FEELING HOT (heat in right nostril), and MYALGIA in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ABNORMAL SENSATION IN EYE (heat in right eye), RETCHING (dry heaves), FEELING HOT (heat in right nostril), MYALGIA, and NAUSEA. On an unknown date, the patient experienced SINUSITIS. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Apr-2021, RETCHING (dry heaves), MYALGIA, and NAUSEA had resolved. At the time of the report, ABNORMAL SENSATION IN EYE (heat in right eye), SINUSITIS, and FEELING HOT (heat in right nostril) had resolved.            No concomitant medication use was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant Follow-Up. TCR attached. Events were not associated with Moderna vaccine but due to sinus problem. Outcome of events recovered/resolved. Further Follow-Up declined.
Redness, heat and swelling of injection arm. Rash on whole upper arm. Fever, chills, aches, muscle spasms, severe joint pain in fingers, ankles, knees and hips, trigger finger in ring and pinky fingers of right hand, softball sized swollen lymph nodes in left underarm. Immediate Treatment: Naproxen. 4/26/21 Primary care doctor, made a referral to orthopedic doctor about the finger pain and trigger finger.I took one course of prednisone prescribed by ortho.  10/19/21 Visited chiropractor for pain in hips and knee. He said this is an autoimmune reaction to the vaccine causing arthritis, recommended turmeric and ashwagandha  for inflammation
Information has been received from a consumer, concerning her daughter who in October 2009 or November 2009 was vaccinated with a dose of MERUVAX II vaccine. It was reported that the patient developed hives 11 days after vaccination. The outcome of the patient was not reported. The patient also experienced adverse events while on therapy with MERUVAX II vaccine (MSD) (WAES#0904USA00971). Additional information has been requested.
My left arm was sore and second day  I felt very fatigued. I had really bad headaches.  My muscle pain was mild but my headaches have not gone away they are usually mild to moderate.
Family members having covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Family members having covid right now) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (Family members having covid right now). At the time of the report, COVID-19 (Family members having covid right now) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No relevant concomitant medications was reported. Treatment information was not provided.  Family members had COVID on 7,8,9,10 November 2021.  Company comment: This is a spontaneous case concerning a male patient of an unknown age,with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19 . The patient received dose of mRNA-1273 on an unknown date and the event occurred in November 2021. Reporter don´t know the manufacturer of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age,with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19 . The patient received dose of mRNA-1273 on an unknown date and the event occurred in November 2021. Reporter don´t know the manufacturer of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Had Hep B vaccine - 3 days later developed erythema nodosum with corresponding fatigue, body aches, headaches, stomach aches and LE swelling.
lost her eye sight for around 5 mins; Impaired vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Impaired vision). At the time of the report, BLINDNESS TRANSIENT (lost her eye sight for around 5 mins) had resolved and VISUAL IMPAIRMENT (Impaired vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided. Treatment information was not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment   Very limited information regarding the date of vaccine administration and the start dates of the events have been provided. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Additional information received patient demographics, dose details and event updated.; Sender's Comments: Very limited information regarding the date of vaccine administration and the start dates of the events have been provided. Further information has been requested.
pt recv vax & next day devel a rash on neck, chest, diaper area & small area on arms & legs;also c/o cold dx (runny nose, cough? sore throat & temp of 99;
Seen by Dr. for c/o frontal (bitemporal) headache.  Pain med given by MD on 7-30-08.  HA's began 7-29-08.  N/V started on 7-31-08.  Dr. said N/V probably from pain med but wanted us to report this.
SEVERE DIZZINESS; SHAKING/SHIVERING; FEELING VERY COLD.
I have a history of visual floaters. Eight hours after the shot, simultaneous with the initiation of soreness at the vaccination site, these increased, while they are usually minor. Also, i experienced a new phenomenon: a translucent paramecium-shaped image in both eyes: lower left of left eye and lower right of right eye. All these symptoms disappeared after 20 minutes or so and did not recur. Yesterday, I visited my optometrist, who did a dilation to check the retina and found nothing amiss. But she thought my experience should be reported.
Started with tongue becoming numb  (4/27)and by next day (4/28) his face was sagging and he couldn't feel the left side of his face - called PCP and they suggested he go to the ER to rule out stroke . While there they diagnosed him w Bell's Palsey and issued prednisone and an anti viral ( not sure of name). said to reschedule 2nd does 10 days out  so rescheduled for 5/10.  On 5/10 Husband called PCP office as his ear has been bothering him to see if he should still get his 2nd dose - Nurse called back and said they don't suggest it .   He has PCP follow up on 5/13 - rescheduled 2nd does later that day in hopes he can receive it for full vaccination . As of 5/11 he can kind of blink on left side and can open his mouth more . mentioned that side of his face feels sore / bruised
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
it made her sick/got horrible sick; This is a spontaneous report from a contactable consumer (patient).   An 84-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 11Mar2021 (Lot Number: EN6206), at the age of 84-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing (stated that she had Covid, she was in the hospital for 35 days). There were no concomitant medications.  The patient stated she got one shot of the Pfizer Covid 19 vaccine and it made her sick on 12Mar2021. The patient said her HCP said not to get another one. The patient stated her health department told her she had no coverage at all. She wants to know if that is true. The patient said she had Covid and asked would not she have antibodies from that. The patient stated that she had one shot and got horrible sick and ended up in the hospital. She stated that it was like she got Covid again. Stated that they took X-rays of her chest and did blood work the same day she went to the hospital and told her that everything was good. The outcome of the event was recovered on 15Mar2021.
Patient experienced severe burning immediately after vaccine was given.  Sharp pain at site.  Muscle became extremely sore and patient was unable to move arm for a few days after.  Discomfort remains with certain ROM activities.  Patient states pain has decreased but continues to linger. No redness or rash noted upon inspection.
Skin on left leg started to burn.  Also, muscle started to twitch. In 24 hrs. it was all over body.  With spasms going off on legs and butt and hip.  Weak and shaky.  Barely able to stand. Went to facility on 3/22/2012 at 2:50 PM and received 11 shots of lidocaine in burning, spasming spots. Went to Dr. for follow up on spasms on 3/23/2012.  She gave me Diazepam.  Went to facility and ER on 03/25/2012 to get more shots, but no Dr. there could do them.  Went to Dr. for more shots.  Could hardly walk.  Seen her on 03/27/2012 at 9:40 AM.  She gave me four more shots.  Suffered until I went to Dr. asking for more shots.  She refused and said to wait 30 days.  She gave me Baclofen 10 mg and Naproxen 500 mg for spasms and inflammation in knots.  Requested nerve test and return on 0430/2012.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), FALL (He fell Friday), GAIT INABILITY (Could not ambulate for 2 weeks) and PYREXIA (Had a fever for 12 hours) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Cold agglutinin disease. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset). On 19-Feb-2021, the patient experienced FALL (He fell Friday). On 22-Feb-2021, the patient experienced GAIT INABILITY (Could not ambulate for 2 weeks) and PYREXIA (Had a fever for 12 hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 19-Feb-2021, FALL (He fell Friday) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), GAIT INABILITY (Could not ambulate for 2 weeks) and PYREXIA (Had a fever for 12 hours) had resolved. Concomitant product used was not provided by the reporter. On 23-Feb-2021, the patient ended up in the ER (Emergency Room) where a CAT scan, urine analysis, blood work and ECG were performed. All with normal results. He is now able to walk with a walker. This case was linked to MOD-2021-211092. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated medical history, lot number and location of vaccination, outcome for events of stomach upset and could not ambulate were updated to recovered.
Swelling, redness, itching, fluid leaking out of injection site, vomiting, diarrhea, weakness, hot sweats, cold chills, blood in stool.  Later- large red swelling at injection site.  Now- red at injection site and white pus.
Patient with swelling, significant pain, and tingling after vaccination. Symptoms persistent at time of evaluation 30 hours later. Had not tried any medication to help with symptoms. No neurologic abnormalities on exam. Symptoms only at site of Bexsero (had second Menveo shot in left arm at same time).
Report 2001030432-1 describes tingling in a 24 year old female who received hep B vaccine recombinant (Engerix B). The vaccinee's medical history, concurrent conditions and concurrent medications were not specified. She received no concomitant vaccines. On 11/16/01, the vaccinee received her second 20mcg right deltoid injection of Engerix B. Two weeks later, on 11/30/01, she started to experience tingling in her right fingertips, followed by shooting pains down the right arm. As of 12/14/01, the vaccinee was also experiencing tingling in her left arm. A doctor visit was required. As of 12/21/01, the adverse events had not resolved.
Tinnitus started on 01/15/2021 in the AM and has not ceased since.  Constant ringing in my ears that never stops.  Other MCC of tinnitus have been ruled out by self.
The original order was for a MMR and Varicella (2 separate injections if it is their first time receiving). Staff gave MMR and MMRV. The evening (late nights), only has one MA on staff which negates the double sign-off to check to make sure the right vaccine is given to the patient.
No other adverse effects have been reported in the patient; a patient who is breastfeeding received a dose of MMR II today; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about medical history and concurrent conditions was not provided. Concomitant therapy included sterile diluent.  On 27-DEC-2019, the patient who was breastfeeding received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # reported as S010704 and expiration date 08-APR-2021, dose and route were not provided) for prophylaxis (Maternal exposure during breast feeding). No other adverse effects had been reported in the patient. No adverse effects had been reported in the breastfeeding infant.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Mild, Additional Details: eyes swollen. headache. took benadryl and advil.
I was getting a flu vaccine ready for administration. As I was attaching the needle there was a clicking sound which at the time I thought nothing of, as the needle I had attached are not the ones we normally have ordered to our office, and so I thought it was just the needle clicking into place. I believe this was the moment that the hub of the needle I was using cracked. As I was unaware of the crack, and did not see any deformities or issues with any part of the needle, I went along with administering the flu shot to the patient. Upon pushing the plunger to deliver the flu shot, instead of going through the needle, came through the crack in the hub of the needle. I gave the patient some paper towels, as he now had most if not all of a Flublock vaccine dripping down his left upper arm. MD aware and instructed me, so long as the patient was okay with it, to give the flu shot again as it was unlikely he got any of the previous one. I got the new flu shot ready using the needles we regularly have ordered to the office, and administered as usual.
Received TDAP vaccine 12/29/08 - felt overly fatigued on 12/30 & early.  12/31.  Late morning 12/31 I developed abdominal cramping - severe- unable to eat or drink without increased in cramping - diarrhea began by afternoon - fever 101.6 that evening & into 1/1/09.  To ER 1/1/09 with diarrhea & other symptoms - dehydrated - Kt level decreased = 2.9 required hydration & Kt replacement.
Developed Hypotonic unresponsive episodes. Went to ER by Ambulance. Discharged after observation. Continues to have syncope spells for 3  more years. Later tested positive for metal poisoning most likely from an inability to clear the vaccines.
About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy...later that night I started with loose stools...The queasiness and loose stools lasted through the next day and than were gone. My muscles in my back, jaw, and arms seem to get tight and than release...almost like spasms....it feels like my jaw is trying to lock. ...This started the first night and is still continuing now.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date: 07-NOV-2020, thimerosal free, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Watery Diarrhea for 7 hours, then loose stools the next day. Mild headache.  Sore legs & fatigue. Itchy palms experienced day 2 post vaccine.   Ist Dose experience lymph node enlargement under arm pit and neck [see  previous note}
Patient is a 75-year-old female presents emergency room ambulatory stable vital signs complaining of shortness of breath.  She has a history of asthma.  Started having exacerbation on Monday and started herself on steroids.  She is on day 4 of prednisone.  She went to her primary care physician today and was given some updraft however her breathing did not improve so she presents to the emergency department.  Denies any hemoptysis.  No leg swelling.  No chest pain. Associated Symptoms: cough, shortness of breath, URI symptoms, wheezing
It has been received from a physician concerning a female patient who on 17-APR-2007 was vaccinated with a dose of ProQuad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
Cellulitis left thigh from DTAP site warm 7x6 cm erythematous over left thigh x 2days following injections. Probable local reaction.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).