chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.). At the time of the report, IMMUNISATION REACTION (Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant drugs were not reported.  Treatment details were not given.
injection site reaction; sore arm 3-4 days  Narrative:  Patient is a 72 year old MALE who received the  1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction  related to the vaccination. ------------------------------------------------------- -----------SYMPTOMS: Fever No If yes temp: n/a Fatigue No Myalgia No  Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction  Yes Other No If yes describe: sore arm 3-4 days
Patient with mild hypotension, lightheadedness, and nausea.  Patient did receive IV fluids with normalization of blood pressure.  Laboratory evaluation was unremarkable.  Symptoms substantially improved with IV fluids and Tylenol as well as IV Toradol.  She was discharged home after observation.
I felt fine until several hours later where I developed heartburn and an uneasy stomach. After 15 minutes I began vomiting and this happened 3 times. I also had diarrhea. This episode lasted about 45 minutes intotal. I went to bed and began to get the chills and very violent shakes. I had to turn on my heater as I was so cold. This lasted 3 hours. After I calmed down and only had a slight headache for the rest of the nite into the next day. I had a very low grade fever of 99. The next day I took 1 Tylenol and was able to eat and drink fine. No other symptoms to date.
Breakthrough COVID.  8/14/2021: patient presented to ED w/SOB and low o2 sats.  States 6 days ago experienced muscle cramping, fevers, chills, & headaches.  States 4 days ago tested COVID + on 8/10. Previously vaccinated with J&J COVID-19 vaccine in April 2021.  Tmax 101 at home, became more SOB and symptomatic, called PCP who instructed him to go to for monoclonal ab treatment consideration.hypoxia 88% on room air, 88% on arrival, 95% with 4L nasal canula. Diagnosed with COVID-19 viral pnemonia, acute hypoxic respiratory failure 8/17/2021: patient discharged
Left deltoid swelling 7 mm diameter red and warm yesterday but improved without any meds/antibiotics.
See attached (pg 2) Consult re: reaction to GARDASIL; 1st GARDASIL given 7/24/08. Saw PCP - Dr around 8-1-08 for physical. At that time patient complained of sore throat and ringing in the ears. Started Z-Pack 8.4.08 x 5days; Saw Dr on 8/28/08 for "red bumps" on left side of body; was put on Medrol dose pack x 5days. Complained of heart palpitations, dizziness; 9/4/08 - Saw Dr. complained itchy blotches on body. Put on Ativan; Saw Dr 9/11/08 for blood work. ER 9/12/08, Fri evening dinner at dinner patient, felt dizzy warm lethargic, fainted and convulsions; had once; CT scan, MRI; Prone to fainting; Started Holter monitor 9/16/08 by Dr x 24 hours; now; Meds: Yaz, Ativan 0.5mg PRN, Xyzal -> Allergies. Blood work -> Allergy to Shellfish
-Patient reports SOB/dyspnea with some mild chest pain beginning 1 day after vaccine that persisted for 4 to 5 days.  After that time, symptoms began to resolve.   -3 to 4 weeks after vaccination, symptoms recurred in addition to having soreness in arm at injection site.  Symptoms resolved again.   -4/11/21 - patient didn't have any significant SOB but did have temporary visual field loss in right eye which resolved. -4/12/21 - patient reported some SOB during the night while trying to sleep -4/13/21 - patient contacted the hospital for follow up on symptoms.  patient advised to come to ED for workup of symptoms.  awaiting results and follow through at the time of this report.
hives on her face; This case was reported by a consumer via call center representative and described the occurrence of hives in a 36-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2018-2019 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Tetra 2018-2019 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, 3 days after receiving FluLaval Tetra 2018-2019 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2018-2019 season and Flulaval Tetra Pre-Filled Syringe Device. 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 reported as follows: The case was reported by patient herself. The age at vaccination was not reported but patient could be 33 or 34 years old at time of vaccination. The patient reported that she experienced the hives on face, 3 days following the vaccination. The hives came and went for a total of three days and then resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073401:same reporter,2nd dose
patient was to receive meningococcal ACWY vaccine and was given MenB instead. Patient had some arm soreness and fatigue day after shots but symptoms have cleared.
Started vomiting and not eating well. ER 4/5 to r/o intussusception > sent home. Worsened over the next day > sent back to the ER > admitted 4/6/2006 until 4/9/2016.  Discharged home > f/u in the office 4/11 significant wgt loss and still not eating well and not smiling.  Follow up on 4/13 > still not eating well but more alert but not smiling > sent for EEG on Friday 4/15/2016 which was normal and was pretty much back to baseline in terms of eating and smiling.
On the evening of the day I received the shot, the area turned red, swelled and itched.  I took Benadryl for the itch.  On Sunday, I stopped by the pharmacy to speak with the pharmacist and show the injection area.  The redness and swelling extended almost to my elbow joint.  She advised me to contact my doctor's office and to report an adverse reaction to vaers..  I called my doctor's office on Monday morning.  I was advised to "give it another day".  On Tuesday, the redness had decreased markedly and the swelling had gone down some as well.  So I did not contact the doctor again.  The swelling was gone on Wednesday and by Thursday (Holiday day) my arm was back to normal.
Fracture of left foot. Diagnosis by x-ray. Diagnosed as fracture of unknown cause. Treatment by podiatrist. Treatment was no surgery but complete immobilization for 3 weeks. I am in the middle of the 3 weeks immobilization.
Patient developed one skin patch within 7 days of first shot.  By December 15th he had rash/patches spreading all over his body.  Rash is still present.  Family doctor did not know how to diagnose.  Dermatologist stated pitarysis rosea.  From online research PR rashes may be common from the vaccine.  Started after first dose and exacerbated by the second dose.
fatigue, sore throat, fever, body aches.  I went into an urgent care and had a Covid PCR test.  It came back positive.  I then asked my doctor for a prescription for anti-viral medicine.
This spontaneous report as received from a nurse refers to a 3 years old female patient. The patient was vaccinated with, .5 ml VARIVAX on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient experienced fever of 104.5 degrees fahrhenheit, 2 days after onset of therapy and small red dots on back. The patient received ADVIL as treatment. The outcome of fever of 104.5 degrees fahrenheit and small red dots on back was reported as recovered/resolved. The relatedness for fever of 104.5 degrees fahrenheit and small red dots on back is unknown for VARIVAX (Merck). Additional information has been requested.
Blood vessels bursting.  First of all the medication that I use to treat heavy menstrual bleeding do to a clotting disorder completely stopped working after the vaccine.  I have had the heaving menstrual periods of my life- losing 3-4 cups of blood each cycle since the vaccine.  Menstrual periods are completely disordered timing-wise- anywhere from 19 to 32 days apart currently..  The really  big problem is that I had a blood vessel burst (stinging and bruising)  in the morning on the bottom of my right  foot just below the ball of my foot, between the big and first (second) toe.  This occurred while I was sitting.  Then  a few hours later the same thing happened in the exact location on the left foot.  Then a few hours later another vessel burst in my left groin area while I was hiking.  Days later I saw a doctor and she thought I had a DVT (deep vein thrombosis) in that groin area.    I have not had vessel breaks before and these hurt a lot  and swelled up and bruised.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 2nd of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: En6200), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (2023) Positive, notes: Antigen test never went negative. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective, COVID-19 cannot be excluded
DTP inadvertently given to 9 adults; only 1 had an adverse event; pt devel swollen nodes in the neck & axilla for 1-2 days & then nodes disappeared;
Hives occur slowly and gradually developed from legs to body to neck, arm and face within 2-3 weeks resulting nonsleep nights. Benadryl taken but drowsy during the day. Then prednisone for over 2 weeks, still did not kill. Then, allertec 4 pills a day with hydroxyzine occasionally finally worked. Allertec was reduced after hives were in control.  About 5 months. The hives occurs again the same day after the booster (3rd) shot on 11/6/2021. And, patient is still on allertec today.
Early Saturday morning, woke with chills, nausea, swollen/red arm, very flushed and hot face. No treatment, did not seek health care. Today, on Monday, chills are gone, nausea continues, arm is a little swollen and tender, and face is a little bit flushed.
24 hours after receiving vaccine, I began getting severe chest pain and shortness of breath.  At 48 hours post vaccine, I called my PCP who advised me to go the the ER. I had pain in my arm (where the shot was given) and pain in my chest on the left side. It radiated to my back. It hurt to take a breath in.  At the ER, I was put on the EKG machine, blood word done, chest xray. My d-dimmer was 660. That was the only number that was not within normal limits. They did a CT scan with and without contrast of my chest to look for a possible blood clot.  Nothing was found. I was sent home with Naproxen and told to follow up with a cardiologist 3-5 days after.  I went to the cardiologist 4 days after the ER, he diagnosed pericarditis most likely due to the covid booster vaccine.
muscle aches, fever chills, tiredness, soreness, swollen lymph nodes under my left arm pit.  change in menstrual cycle. My normal cycle is about 35 days and after receiving both doses of the vaccine my period came significantly early (I got period one week after each shot, which resulted in a 28 day cycle and 24 day cycle).
Headaches, lightheaded, and nausea daily. I?ve never had this issue before. The headaches last anywhere between one to two hours. I drink over a gallon of water and have a healthy diet. The headaches have become enough for me to have to sit down and catch my breath. I never had this issue prior to receiving both doses.
The next day following the vaccine, I developed a red itchy rash mostly on the back of both of my upper arms, though it was not very red around the injection site.  The arm rash was very itchy and was from the top of my arms near my shoulders down to the elbow area on both and the back side of the arm was the worst and the most intense itching and felt hot.  The rash also presented on the outer ridge of my left ear.  It was bright red and itched for several days.The right ear was a little itchy, the the left ear the most affected.
I had pain on my injection site for about 5 days. Today is day ninth of my vaccination and I have a red rash near my injection site. The area feels warm to the touch.
Varicella rash 15-20 lesions just in time for new sister to be born & he couldn't see mom or baby in hospital.
Significant correction performed. Suspect product coding was changed from IPV (VERO)-product code 059 to RABIES (HDC) VACCINE- product code 046. Initial unsolicited report received from a healthcare professional on 25 June 2014. A 30-year-old female patient had received an intramuscular first dose of IMOVAX RABIES (lot number J1676-1) in the left deltoid on 18 June 14 and had also received an intramuscular dose of RABAVERT (manufacturer: Novartis, lot number and dose in series was not reported) in the deltoid on 21 June 2014. "At the time of vaccination the cat bite to the patient on left calf." leads to understanding that the patient was bitten by a cat during the vaccination. The patient had Indomethacin allergy due to which the platelet count was decreased, Verapamil allergy, migraines and left kidney was removed due to hydronephrosis. It was reported that the patient was exposed to poison ivy two weeks earlier. Patient has been using Neosporin ointment on cat bite and red patches. On 22 June 2014, the patient developed a red blistery, patchy, circular rash, one patch on right forearm, one patch on left forearm, one patch on right lower leg and also had one blister in her mouth. On 23 June 2014 the patient had received a dose of HyperRab (Novartis) in left calf. On 25 June 2014, the patient had received an intramuscular dose of Imovax vaccine (batch number: J1676-1) in the left deltoid. The patient corrective treatments and laboratory investigations were not reported. The patient required ER/doctor visit. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information was received from a physician on 13 February 2015: No new information was received. Addendum on 05-MAY-2015: Upon second medical examination of case at time of internal review a significant correction was performed to change the suspect product coding from IPV (VERO)-product code 059 to RABIES (HDC) VACCINE- product code 046.
Face swelling and arrhythmia ; went to ER; benadryl given; heart rate normalized after IV benadryl
A nurse reported that a female pt received Flu Shield '00-'01 and Pneumovax 23 (MSD) vaccines on 11/13/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Flu Shield.
Swelling, pain, tenderness at site of injection night of vaccination; by 9 PM next night, onset of chills, nasal congestion; awakened with severe sore throat at 3 AM next day, with more chills, malaise, congestion for 3 more days, transient generalized muscle aching ~ 5 days after vaccine, with continued unrelenting congestion & onset of bronchial symptoms with productive cough about 1 week after vaccine; congestion & productive cough continuing to present, 2 wks after vaccine.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the PROQUAD (Merck) series that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
On Thursday noc pt arm became sore & pt had a red spot about the size of quarter @ the site of inject; By Friday the red spot grew to about 4" in diameter & pt arm was tender & warm to touch;
Terrible body pain, high temperature, chills, headache, confussion, dizziness, fatigue for almost a week.
One month after 2nd vaccine in Gardasil series (in Dec. 2007), began having tingling and numbness on and off in the hands, feet, arms, and legs, including right arm (site of injection).  After third vaccine (in April 2008), immediately noticed an abundance of eye "floaters," including a dark, shadowy floater.  Tingling has continued intermittently through the present date (June 5, 2008).  I have seen numerous doctors, a neurologist, an ophthalmologist, and counselors to deal with the stress of the ordeal. I have received clean tests for Lyme, B12 deficiency, rheumatoid arthritis, high cholesterol/diabetes, anti-nuclear antibodies, TSH RPR, and segmentation westergreen.  I have also had an EMG, a full battery evoked potentials test, and an MRI.  All test have come back normal, but symptoms are persisting. 6/6/08 Patient w/numbness & tingling of hands/feet.  BCP changed. 6/20/08 Reviewed PCP medical records of 1/9/08-5/8/08 which included neurology consult.   FINAL DX: sporadic paresthesias Records reveal patient experienced hand tingling & numbness for 2-3 days, more on the right, in early January.  Developed dizzy spells w/lightheadedness intermittently.  Referred for second neuro opinion.
3-4 days after vaccine administration the patient developed multiple "small red bumps" near injection site that progressively spread to chest wall, left arm and back.  Mildly itchy, not painful. No fever. Otherwise well. On 4/20/07 he sought medical attention.
I had a persistent, dry cough and took a home antigen test and got a negative result. Around 12/22/2022 or 12/23/2022, I took another test and got a positive result. I didn't really have any symptoms aside from the cough. I didn't take any antivirals, as it was too late to begin taking by the time that I tested positive. The cough lasted for about a week and then subsided. I had no trouble breathing.
Vertigo; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. 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 12Apr2021, the patient experienced vertigo and dizziness. No therapeutic measures were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the event vertigo and dizziness was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left ear tinnitus starting about 2-3 weeks after 2nd Pfizer Covid-19 vaccine dose.
Site: Bruising at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Mild