chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 5 month old patient who was vaccinated with Rotateq 2 mL PO. The nurse reported that the 5 month old infant was given the second dose of Rotateq late. The second dose was given 12 weeks after the first dose. It was reported that therapy with Rotateq was stated "at two months old".
nurse reporting that patient had vomited after administration of ROTATEQ; This spontaneous report was received from a registered nurse, referring to an infant male patient of unknown age. The nurse was unaware of any patient's medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications.   On 04-AUG-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered (dosage, vaccination scheme, frequency, lot number and expiration date were unknown by the reporter) as prevention of rotavirus gastroenteritis. Immediately after the administration of the vaccine the patient vomited 4 times. In addition, the nurse reported that the infant had been drinking formula prior the vaccination and that, this was a "well child checkup" for an infant. There were no laboratory diagnostic studies performed. No other adverse events were reported in the patient.   The outcome of the event vomiting was reported as recovered. The causal relationship between the aforementioned event and therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), was not provided.
Baseball sized diameter swelling around injection site, red (like a rash) in color, itchy, painful to touch and warm to touch. Rash looked yellow to black and blue around the edges as it progressed down the arm. Over the course of 5 days spread from injection site, around the elbow and into the forearm. Hip, knee, foot, shoulder and elbow pain on left side only, Body aches,  nausea, visual impairment and loss of balance. Difficulty concentrating and relative "brain fog". Severe drowsiness in the sense of falling asleep while talking to someone and then no memory of it. Chest pressure and constant feeling of being out of breath. Cannot catch breath walking across the house from one room to the next. Severity of symptoms subsided within 24 hours, but some linger up to the time of this report. They are shortness of breath,  rash with warmth and pain, lack of concentration and brain fog. Elbow still tender to touch.
Local reaction redness and swelling (L) Delt Body aches, flu like symptoms, chills for 48 hours. Also started LOVASTATIN for Chol and is still having chills, leg cramps.
Localized redness and pain to right arm where vaccine was given. Employee reported to ER and was treated. CBC was ordered and was within normal limits. Provider states that the symptoms should resolve with time and to report worsening or unresolved symptoms.
Pt awoke p/nap; approx 3 hrs p/vax given screaming continually; Mom held walked w/tried to comfort, pt cont screaming for approx 4 days; would sleep but slightest noise would awaken; t103, rt leg edematous, & very sore;
Fever.  Then mild red small dot rash started on 10/16/11 at about 10:00 PM.  As of 10/18/11 rash covers 90% of body. Fever low grade on and off.  Administering Tylenol.
covid vax pfizer 4/23/21, lot EW0162, and in f/u covid vax pfizer 11/12/21, lot # FJ8757 on 18 December 2021 he had acute onset left dense hemiparesis with near anarthria, MR imaging at hospital on 16 December 2021 without restricted diffusion or evidence of intracranial hemorrhage appears to have been before this most recent fixed left dense hemiparesis, does have a history of hypertension and diabetes not well controlled and medication noncompliance with myeloma diagnosed in November 2005 status post auto transplant 2006, he died on 22 December 2021 due to head bleed
Mom states about an hr post vax pt went to sleep & when woke up eyes were swollen & had rash around eyes; Taken to ER given DPH;
Post vax, the child had a fever of 105. Did seek medical assistance at a local clinic where he was prescribed Tylenol. Fever did not come down and mother took child to ER. Did not tell ER that he had the vaccine that day; was treated as an infection and given Amoxicillin and other medicines for increased temperature.
Rapid heart rate 108 bpm.  Feels like a am heavily working out but I am a sedentary person.  Injection site of arm looks fine but there is still pain when I try to lift my arm
Friday morning no appetite, headache.  Saturday AM Large knot in arm, swelling temp of 100.6.  headache worse, could not move hands, still aches.   Monday morning still large red hot .  still has headache,  red and swollen to elbow.  Went to physician and got a shot.,
Mother stated that her daughter had a lot of shaking & chills throughout the night that seemed quite severe. Then she began to develop a fever. Stated she administered Tylenol and fever began to break and symptoms improved. Kept her home today to rest. Stated her arm was sore and she was unable to sleep on that side during the night. Stated the one on the back of the arm below the armpit was the one that bothered her the most.
92 days out from first dose and has not yet received his second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (92 days out from first dose and has not yet received his second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (92 days out from first dose and has not yet received his second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (92 days out from first dose and has not yet received his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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 reported.   Reporter did not allow further contact
On evening of vaccine had very bad pain in left arm at injection site.   Facial assymetry, noticed on Feb 11, 2021 during zoom call--left and right sides of face not in sync, left side of face slightly droopy and slack.   Televisit with primary care physician on Sat Feb 13, who suggested mild Bell's Palsy and proscribed course of steroids and an antiviral to prevent worsening.  Suggested there may be correlation with Covid 19 vaccine.
Approximately 3 weeks following  receipt of first COVID vaccine, on 5/5/2021, was talking a walk when experienced a "warm splashing" feeling on one calf.  Following the walk, a pulsating feeling occurred in both feet, hours after the walk.  The pulsating feeling in the feet migrated to behind both knees and continued in both feet.  This feeling is not continual but persistent.  The feeling "moves around" the legs and the following day that area will be sore.  On May 13, received second dose of Pfizer vaccine; the leg feeling remains constant but has lessened in severity, but some days the feeling worsens.  Following second vaccine also began to have pain in the elbow area of both arms, but "mostly in the left".  Had one episode of the feeling extending into the bicep area.  Has been to the doctor twice.  First visit blood panel and Lyme Disease test obtained.  Blood work was normal, except for slightly elevated liver enzyme which client attributed to some pain medication that had been taken.  On June 18th, had Ultra Sound of legs performed for vascular study; has not heard results. States contacted testing facility and results had not been sent to his ordering physician, but "someone there are read the report" and supposedly normal.  Is scheduled for an EMG on 6/24/21.  Encouraged client to monitor symptoms and if leg pain / spasm worsen or other symptoms arise, to seek out ER care.
Temperature 103(AURAL)within 5 hours of receiving vaccinations on 09 July 07; 24 hours later fever had resolved and approx. 3 in circumference red, warm, swollen area ("hard as a rock") appeared on (R) lateral thigh. Seen on 11 Jul 07, diagnosed cellulitis, prescribed ice, motrin and Cephalexin. Telephonic contact with Mother on 12 July 07: patient did not start Cephalexin but all symptoms have fully resolved.
Patient developed extensive acute bilateral pulmonary emboli, R leg DVT, large LV thrombus, acute heart failure, hypertensive emergency  with symptom onset 8 days after immunization. She presented to hospital 22 days after immunization for progressive sypmtoms including shortness of breath.
Patient developed diabetes mellitus within days/weeks following first vaccine dose.  Patient had A1c measured at 5.6 % on 6/16/2021 prior to vaccination.  Pt admitted to hospital 9/29/21 with uncontrolled DM and A1c of 13.5%.  Has been diabetic ever since.
Reporter indicated that give Engerix-B mostly to dentists office, police & fire persons & there are many failures to seroconvert;
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 1st of 8 patient.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034597 same  drug, reporter and event but different patient;US-PFIZER INC-2021034598 same  drug, reporter and event but different patient;US-PFIZER INC-2021034599 same  drug, reporter and event but different patient;US-PFIZER INC-2021034600 same  drug, reporter and event but different patient;US-PFIZER INC-2021034601 same  drug, reporter and event but different patient;US-PFIZER INC-2021034603 same  drug, reporter and event but different patient;US-PFIZER INC-2021034596 same drug, reporter and event but different patient.; Reported Cause(s) of Death: expired before receiving the second dose
Pt received first series of varicella virus vaccine live in 1997 and had a negative titer after six months. Second series of varicella virus vaccine live was administered in 1998 and the titer was also negative. Pt was not diagnosed as immunosuppressed.
pt recvd vax & t103 & is shaking; inst to take pt to ER or PMD immed;
Feeling warm, sweating, hypotension, feeling lightheaded over course of 40 min
I was given the Pfizer vaccine at 7:30am and waited for 20 minutes. I headed to my car and started driving home. A few miles down the road I started getting tingly on my left arm (where the shot was administered), then it traveled up to my face and down my left leg. I realized I was getting lightheaded but I was driving on Hwy 75 and needed an exit FAST. Thankfully I was safely able to exit and park in the Mall parking lot.  I called husband and my dr immediately to let them know where I was and I needed help. As I?m talking to them my throat started getting cottony and tight, and that tingly feeling that made it?s way down my left side was coming up my right side. When it got to my heart it hit my heart with a *boom* like a really hard heartbeat. I was seriously freaking out and thinking I am going to pass out and no one is going to be able to find me. My dr's office advised me to go to an ER. I found a small ER  across the highway from me and decided my lightheadedness had subsided enough that I could get there. They monitored me for an hour, gave me no meds, did an EKG and discharged me once they felt my symptoms had mostly stopped. No discharge instructions other than to follow up with my dr. My dr has never responded to my efforts to reach her. For the remainder of that day and the next day I continued to feel itchy, a cottony throat, and like I was getting pricked with needles all over my body, but specifically on my fingertips and the back of my knees. A friend suggested I take some Benadryl, and that drastically improved those lingering symptoms. I took 10ml of Children's liquid Benadryl on April 13 at 8:00pm, and since it made me feel better, I did the same dose again on April 14 at 9:00pm. I was doing fairly well other than being very tired and sleeping quite a bit: 5-6 extra hours each day. On April 16 at 4:45pm I stood up and then leaned all the way over to the ground to pick something up and my heart beat super hard again, and I felt like I was going to throw it up. I got lightheaded and my heart just hurt afterward so my husband took me to another ER. They did another EKG, took a chest X-ray, did some blood tests, gave me baby aspirin and some anxiety medication by IV. After monitoring me for a couple fo hours, they sent me home to rest. My heart has been very sore ever since.
Possible shingles; reaction at the injection site / swelling; reaction at the injection site / redness; developed a H/A; started with chills; felt feverish; with shaking; rash with radiating pain; bruising at the injection site.; she felt like she had a bug bite on her lower abdomen; rash on her L lower abdomen with radiating pain; Felt bad for 2 days; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2020 09:30, the patient received the 1st dose of Shingrix. On 4th November 2020 18:00, 8 hrs 30 min after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever and tremor. In November 2020, the patient experienced injection site bruising, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, headache, chills, fever, tremor, painful rash, shingles and lower abdominal pain were unknown and the outcome of the injection site bruising was not recovered/not resolved and the outcome of the feeling bad and radiating pain were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site bruising, headache, chills, fever, tremor, painful rash, shingles, feeling bad, lower abdominal pain and radiating pain to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix shot around 9:30 am and around 6 pm that evening she developed a reaction at the injection site on her left arm with redness and swelling that radiated down to the middle of her arm.  At 6 pm she also developed a headache then started with chills and felt feverish with shaking.  She took Tylenol and felt bad for 2 days. Then it resolved.  Five or 6 days later she felt like she had a bug bite on her lower abdomen but it was not itchy.  She had pain with this and that evening she noticed she developed a rash on her left lower abdomen with radiating pain for 3 days.  It spread to her back up towards her spine. She had bruising at the injection site at the time of reporting. Her physician put her on Valtrex which she had been on since 17th November 2020.  The reporter consented to follow up.
Well i had a coronary artery dissection. I had to have 4 surgeries on heart abdomen liver and lung. The outcomes where me having to be on extreme heart medication for the rest of my life and blood thinners for the rest of my life and I lost a twin baby due to all this as well and now the doctors say I cannot have kids for the rest of my life otherwise something could happen like this again
Administered Janssen Covid vaccine 1 day after expiration.  Patient is currently doing well
3 days later I woke up with the swollen lymph nodes in my arm and then the following day which would have been Tuesday I had one on my neck and then Wednesday I had swollen I mean my muscles are sore in my back and in my chest my seat belt was real tight to put on and today is Thursday now I feel like it's moving down to my hips.
pt recv vax 18DEC97 & 2JAN98 pt devel hives & it was reported that pt never had hives before & has no allergies;
redness, rash and inflammation at injection site, unknown which vaccine caused. mother requested this be submitted to VAERS
Fever; Arm pain, radiated to neck and shoulder; Arm pain, radiated to neck and shoulder; Arm pain, radiated to neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, neck pain and shoulder pain. On 2nd October 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the neck pain and shoulder pain were unknown.   It was unknown if the reporter considered the pain in arm, fever, neck pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient reported that, she received Shingrix vaccine into the right arm and experienced arm pain and fever that started on the same day. The fever resolved the next day and the arm pain did not resolve until a month later. The patient described the pain as starting in her right arm and radiated to her neck and shoulder.  The reporter did not consent to follow-up. Additional supportive information:  This case has been linked to the case US2022056753 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056753:Same reporter.
Lightheaded Dizziness, anxiety weak - 14:10  28 y/o started to feel light headed after recieving the Moderna  vaccination. V/s was taken, BP  78/53  HR 53  RR-16,  O2 sat - 100% RA  Temp  97.6.  Nurse elevated patient legs, gave patient ice chips.  Continued to monitor patient every 15 minutes for 30 mins.  14:25 pm - Reassessd patients blood pressure, 100/62  HR 65  rr 16, patient has no signs of distress,  Breathing is regular and unlabored.  1440 pm Nurse reassessed patient vitals BP 110/70  HR 65  RR 16 02 Sat 99% temp 97.8.  Patient breathing regular/unlabored, patient stated taht he is feeling better than before.  Patient was released with family.  Nurse educated pt on side effects and severe allergic rea ction to call 911 if experience at anytime.
Flu vaccine at approximately 1 PM on 9/16/13. At 4:30 PM patient complained of chest tightness, feeling lump in throat and wheezing. States she took a decongestant and it resolved. Full recovery noted.
Fatigue, achy muscles throughout whole body, weakness in legs, upper respiratory congestion, irritable.
COVID vaccination administration site was high up on my arm more in the shoulder.  Three hours later my arm began to hurt and lose range of motion.  By Wednesday, I had very little range of motion due to pain and inflammation and was seen by my doctor who prescribed anti-inflammatory medication.  Doctor's Tx is successful in restoring movement and reducing pain. The medications prescribed were oral meloxicam, topical lidocaine, and topical Voltaren.
This spontaneous report was received from a pharmacist and refers to 18 patients of unknown age and gender. Information regarding pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates in 2017, reported as from 29-MAR-2017 through 20-JUL-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX VIAL 19400 PFU, lot # M041085 with expiry date 03-JAN-2018 and lot # M042850 with expiry date 18-JAN-2018 (dose, route, anatomical location and dose number unknown) for prophylaxis. No adverse effects were reported. The administered doses of both lots experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 hours 30 minutes. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case.
Patient woke up unable to move 08/18/2018 at 8am. She stated she slept longer than normal, but also has muscle pain all over her body not just in her right arm. She took a TYLENOL at 11 am and the pain has subsided some, but she is still having difficulty moving. She called the pharmacy at 1245p on 08/18/2018 to report the severe muscle pain and requested we submit a report.
rash with 2 lesions on left arm, one near wrist, and other near elbow. Lesion on rt forearm with 2 small bumps on rt index finger. Also has one lesion just right of umbilicus and 2 lesions on rt hip. First lesion appeared yesterday, and has gotten bigger with new lesions appearing. Reports itching, no other sx.    Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Woke up deaf in left ear - treated with high dosage of prednisone. Complete hearing restored after 4 days.
Pt got moderna 1st dose and got pfizer the second dose.  Not sure why he asked for pfizer second dose
Arms with swelling c/o slight tenderness color good. Plan, prescribed care MOTRIN prn with cold compresses prn. Monitor.
Initial report received from a nurse in the USA on 8/18/05. A 14 year old female patient was diagnosed with papilledema 69 days after receiving the IM injection of Menactra, lot number U1575AA on 6/9/05. Site of administration not reported. The patient received in concomitant the IM injection of Td, lot number U1370BA. Site of administration not reported. On 8/17/05 the patient was seen by her optometrist for a routine visit and was found to have papilledema of unknown origin. The patient is asymptomatic. The patient denies any illness at the time of vaccination and was on no medication. Follow up information received on 9/6/05 from a physician. The patient was referred to a neurologist on 8/31/05 for papilledema one month's duration. It was noted that the patient had been taking minocycline since March 2005. Upon examination, it was noted the patients' visual acuity was 20/20 in the left eye and 20/25 in the right eye. The neurologist's impression was pseudotumor cerebri, possible secondary to menicycline. The minocycline was discontinued. It was not reported whether the patient has recovered from these events. Based upon the new medical information provided, this case has been upgraded to serious. (OMIC)