chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 5th in the afternoon, I began having bad itching in both hands and arms with no hives. Itching continued on the 6th and small hives began to appear. On the 7th, the itching continued and began to spread. On the 8th, the itching spread to my stomach, back, and feet. The 9th, the itching became unbearable and continued the 10th-11th. Saw Dr on May 10th and they didn't have any suggestions what caused it. BP was very low at the clinic. On May 12th, itching is more bearable. Was told to take Benadryl for itching.
pt noted in MAY joint pain rt & lt hand;now w/only pain rt hand;seen by MD;had lightheadedness, ringing in ears, irritated feeling both ears in 7/99 still present 9/20/99;aggravated pain in rt hand between 2nd & 3rd metacarpal;
I had a patient present with a red, itchy, "angry" looking rash on both her legs which she described as effecting her from the waist down and feels like she's wearing "wool pants". Patient came in wearing shorts due to not being able to wear pants. On 10/2, the patient was given FLUCELVAX, PNEUMOVAX 23 and first dose of SHINGRIX. Per patient, the next day she had the above mentioned rash "from head to toe". She had prednisone from a previous condition and took that plus Motrin and the rash resolved for "about a week". On Monday of this week, the rash reoccurred on the patient's legs. She presented to the pharmacy asking what the cause was, do we have anything OTC that can be recommended and what should she do. I called GSK and spoke with a representative. She asked many questions regarding the case (no HIPPA information was released) and then told me that she would have to have me speak to a PharmD on staff. However, they are experiencing a higher than normal call volume and they would have to call me back (as of the sending of the email, they have not contacted me). A similar situation occurred when reaching out to Merck. I was on hold without reaching anyone. I also contacted the patient's doctor who recommended that due to the length of time (20 + days) that she should go to ER immediately. I gave the patient this information and recommended that she go to the ER immediately. She said had been there a month ago and incurred a $1500 bill and could not afford to go. I urged her to go repeatedly. She inquired if there was an OTC to help with the rash. I said without knowing the exact cause and with the severity of the rash that I would not recommend anything except an ER visit. She asked me if I would contact her when and if I heard back from GSK and Merck. I agreed.  She then left the store.
Day 1- sore arm within 1 hr....8 hrs-vomiting and fever 9hrs through rest of night-vomiting  Day 2-vomiting all day  Day 3- fine all day until 11 PM-vomiting continues
10 min after vaccine while in observation patient reported itchiness moderate generalized. on physical assessment patient noted with rash developing in lower back, neck and bilateral arms. vital signs  bip 154/91,hr 83, rr 19 oz sat 100% ra, temp 37 orally. patient transferred via wheel chair to  express symptom management unit. accompanied by ARNP. report given to express management ARNP
Woke up morning after vaccination paralyzed for approximately 15 minutes, suffered serious cold symptoms through December treated by urgent care several times,  no positive covid tests Beginning of January was bedridden Severe pins and needles and heavy feeling in feet which traveled to face.. Burning skin, pain in the back of the neck head,Favors chills sweatingFeverchills sweating Headaches completely lethargic unable to function On any level or return to normal duties . Current day August 25th 2022 neuropathy from feet to face continues chronic chronic brain fog loss of cognitive function unable to work likes feeling heavy digestion not working that was not working you're an attractive fiction for 8 months untreatable by antibiotics . Was given at least 10 rounds of antibiotics from several doctors over the course since January. Eyesight failing unable to Work or function in normal capacity, unable to do basic chores around the house around the house. Ringing in ears Feeling lethargic Memory loss Unable to formulate sentences clearly speech  Muscles vibration since January Speech Speechsometimes impaired.. And several doctors  2 primaries urologist neurologist gynecologist.. All tests have come back clear no diagnosis to report it No reason for all systems failing.
2/14/21 - went to ER with chest pain - DX Pericarditis Inpatient hosp 2/14-2/17/20 - put on Colchicine for one month   5/9/21 - Went back to ER with chest pain and shortness of breathe - DX Cardiac Tamponade - Hospitalized 5/9-5/13/2021 - had surgery to drain fluid and to put in a pericardial window - put on Colchicine for 4 months.
Information has been received from a consumer concerning her 42 month old son with "gene mutations" who "when he was 15 month old" in approximately December 2006, was vaccinated with MMR II (lot number not available). The patient had a lot of problems since receiving the MMR II (lot number not available). The patient had been diagnosed with autism, had developed many allergies, had gastrointestinal problems, had had fevers as high as 105 degree and had a very weak immune system. The patient had sought unspecified medical attention. At the time of reporting the patient's adverse events persisted. Upon internal review, the patient's autism is considered to be other important medical event. No further information is available.
Upon receiving the SHINGRIX vaccination for the second and final time on the recommended 6 months schedule, I have experienced significant hair loss that is continuing. Have never had an issue with hair loss before.
Not sure if it is related but I developed Shingle like rashes about 3 weeks after the 2nd dose of COVID vaccine.   - I did not received the Shingrix - I gave birth in Dec 2020 and currently breastfeeding - I am not under stress and sleeps 7-8 hours a day - I do not have a weaken immune system  Timeline: - Right thigh close to hip area felt very warm around 4/16 - Lower back pain on the right side 4/18 - pain developed on right thigh closer to the hip area  4/19 - Rash developed on Right lower back similar to bug bites 4/20 - Rash developed on the right thigh close to the hip area 4/22 - Visited the doctor and was prescribed antiviral medication 4/24 - still has mild pain (2/10) when touched but rash has gotten a lot better as of 5/4
had shot had mild case; mild case broke out; mild case broke out; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot had mild case) (serious criteria GSK medically significant), shingles (Verbatim: mild case broke out) and shingles (Verbatim: mild case broke out). The outcome of the vaccination failure was unknown and the outcome of the shingles and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 The reporter reported the case via interactive digital media. The reporter's mother was 82 and her doctor recommended her to get the shot.  The reporter suspected he had patients with Shingles.  She had to pay about 128 dollars for the shot.  2 weeks later she had a very mild case.  She broke out a couple more times, but they were tolerable. The reporter got the Shingrex vaccine and had a mild couple cases. This case has been linked with the case US2023AMR057461, reported by the same reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR057461:same reporter
Information has been received from a Physician's Assistant concerning a female patient who on 08-AUG-2007 was vaccinated with her first dose of Gardasil. A couple of minutes later, the patient became dizzy, fainted and hit her head against something in the office, and had seizures. The office then had paramedics come and take the patient to the hospital. The amount of time the patient stayed at the hospital was unknown. Her outcome was  unknown. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.
High fever 102.9 for two days; fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 08Mar2021 at 17:45 (Lot Number: EN6206) as dose 1, single for COVID-19 immunization.  Medical history included COVID from an unknown date prior to vaccination. The patient did not have allergies. The patient was not tested for COVID post vaccination. The patient's concomitant medications were not reported. On 09Mar2021 at 12:00, the patient had high fever 102.9 for two days, fatigue and chills. The patient did not receive treatment for the events. The outcome of the event high fever 102.9 for two days recovered on 11Mar2021 while the other events were recovering.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of (VAQTA) (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A report had been received from the health professional concerning an 11 years male patient. The patient's medical history, concurrent disease and concomitant medications were not reported. It was report that patient received FLUMIST QUADRIVALENT (intranasal) on 27-Oct-2014. Patient returned to pediatrician's office with flu-like symptoms on 05-Nov-2014 and Flu test was negative then, returned on the 06-Nov-2014 and Flu test was positive. Patient was diagnosed with influenza. Patient was still symptomatic. At the time of reporting, the event of influenza was ongoing. The reporter considered the event of influenza to be serious.
Information has been received from a licensed visiting nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who on 20-JAN-2011, was vaccinated with a first 0.5ml dose of GARDASIL (Lot#667866/1437Z Exp date unknown), IM. At the time of the report the patient had 19 days of gestation (LMP on 01-JAN-2011; EDD on 08-OCT-2011). Follow-up information has been received from a licensed visiting nurse who stated that the female patient with anemia on 20-JAN-2011, was vaccinated with the first dose of GARDASIL (lot# 667866/1437Z). Concomitant medication included iron prenatal vitamins. It was reported that the patient had 3 previous pregnancies and 3 full term deliveries. The patient did not have any spontaneous abortion, any spontaneous termination and any fetal deaths. It was unknown if the patient had any birth defects and infant complications in previous pregnancies. Additional information has been requested.
Severe body aches, abdominal pain-over the following few hours was unable to walk due to muscle pain, HA and chills.  I've had rhabdo in the past.  This felt like rhabo however I did not have rhabdo in response to vaccine.
Developed rash on stomach, back and neck about 2.5 days after. Now at 3 days after vaccine and rash is worse. No fever or any other symptoms besides rash and itchy skin all over the body.; Developed rash on stomach, back and neck about 2.5 days after.; itchy skin all over the body; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0161) via an unspecified route of administration in the arm left on 12Apr2021 at 12:00(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history were not reported. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the arm left on 22Mar2021 at 11:30(at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, about 2.5 days after, the patient developed rash on stomach, back and neck and on 3 days after vaccine rash was worse. It was reported that the patient had no fever or any other symptoms besides rash and itchy skin all over the body. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events rash on stomach, back and neck and itchy skin all over the body was not recovered at time of this report.  No follow-up attempts are needed. No further information is expected.
Arm soreness; Rash at injection site; above and below is redness; rash and redness on the arm; Rash at injection site; above and below is redness; rash and redness on the arm; experienced redness and itchiness on the same injection site; This is a spontaneous report from a contactable consumer or other non hcp.A 17-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 30Apr2021  as DOSE 1, SINGLE for COVID-19 immunization(age at vaccination17 years).The co-suspect drug included as Ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (JUNEL) taken for Birth control, It just says 28 days and does not says any mg or anything, daily just once a day orally. start and stop date were not reported. on 02May2021 the patient experienced arm soreness, rash at injection site above and below is redness, rash and redness, experienced redness and itchiness on the same injection site. The patient has not received any treatment Caller would like to know if her daughter can take anything for the redness, soring like anti-inflammatory and antihistamine? Or if she can put any topical cream on the site following getting the vaccinated. Caller would like to have recommendations about letting her daughter get the 2nd dose of the vaccine. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
hard time lifting his arm over his head; headache; pain on the injection site; little nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (hard time lifting his arm over his head), HEADACHE (headache), VACCINATION SITE PAIN (pain on the injection site) and NAUSEA (little nausea) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (pain on the injection site) and NAUSEA (little nausea). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (hard time lifting his arm over his head). On 13-Apr-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (hard time lifting his arm over his head) had resolved. On 15-Apr-2021, HEADACHE (headache), VACCINATION SITE PAIN (pain on the injection site) and NAUSEA (little nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to MOD-2021-077884, US-MODERNATX, INC.-MOD-2021-116622 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: followup received on 17-may-2021 contains no significant information; Sender's Comments:  MOD-2021-077884:same reporter US-MODERNATX, INC.-MOD-2021-116622:Case for patient dose 1
PATIENT APPEARED LIGHTHEADED THEN SEEMED TO  PASS OUT FOR  8 TO 10 SECONDS WITHIN 2 TO 3 MINUTES OF THE VACCINE BEING ADMINISTERED.  HE CAME TO  AND WAS ABLE TO SPEAK TO THE EMS STAFF WHEN THEY ARRIVED. PATIENT WAS TAKEN TO ER FOR EVALUATION.
I had a common symptom and after I got a shot I had an allergy, rash, difficulty breathing, fast heartbeat and weakness.
Patient states approx 1 week after Flu shot she began experiencing stiffness in left arm that would be painful at times and wake her at night. The stiffness is intermittent and does not happen all the time.
On 10/27/99, the pt experienced a bright red rash under both arms which itched and hurt. The rash lasted approximately 3-5 days and resolved.
the portion given was the diluent part of the vaccine with no reported adverse event; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00903542).  This case involves a six -month-old male patient who experienced the portion given was the diluent part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient past medical history, medical treatment, vaccination and family history were not provided.  On 17-Dec-2021, the patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U7013AA and expiry date: not reported, solution) (frequency: once) via intramuscular route in left leg for prophylactic vaccination.  It was reported "They would like to know what to do as the parents do not want to repeat the ActHib. The ActHIB was mixed with and caller states nothing. Clarified the portion given was the diluent part of the vaccine. Caller wanted to know if they could use the diluent for the COVID vaccine since she thinks it is 0.4 % sodium chloride to mix with the powder that is left?".  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hard lump in left arm near injection site. Swollen lymph node. Slight fever. Irritability. Tiredness
Pt states that 30 minutes after administration of flu and pneumonia shots in Left arm, that arm was red, swollen with a hard knot, and by the next day the redness and swelling, and pain had radiated from shoulder to elbow. Was told by MD that it was a staph infection caused by needle or vaccine
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 23-JUL-2015, the patient was vaccinated with one dose of improperly stored GARDASIL 9, intramuscularly, lot/batch # reported as L004741 (lot# not valid for GARDASIL 9, expiration date: 04-MAR-2017 (strength and dose were not reported). The patient was under the care of a physician during the vaccination. No adverse experiences were reported. Additional information has been requested.
Six year old patient was given the Pfizer 5-11 year old Bivalent Booster at 0.2mL with no diluent used. Patient was notified by doctor about medication error and advised on next steps of care. No symptoms at this time.
pt recv vax & devel inj site rxn;pt dx as having cullulitis;use of an ATB for tx of the rxn has not been confirmed;This is one of three pt from this site who recv same lot# & exp above rxn;
Pt wanted to notify organization of her adverse reaction to the tetanus shot that was administered in left arm Nov. 6, 2002. That 11/6/2002 night pt experienced the normal soreness. The next day 11/07/2002 pt noticed shoulder was tender. Later on that night, pt noticed severe muscles cramps were moving across back and into right arm as well. On 11/08/2002, pt woke up in so much pain that pt could hardly dress her child. It took more time to move and pt was almost in tears when returned to clinic. They prescribed some muscle relaxers to make pain manageable. this helped for a few days. On 11/11/2002. pt returned to the office for a follow up on finger and noted to him that she was concerned that her muscles were still extremely week. During that time the noted a hard knot in my arm and some redness on my chest. On 11/14/2002, pt went back to the MD , gave pt a steroid shot and prescription to help. He stated that he did not feel that this was still a reaction to the Tetanus shot, however Pt feels that it is. He also gave me Ultracet to help ease the pain that still existed. On 11/16/2002, pt had an appointment and called to cancel. She felt that she wanted to see if pain would go with the steroids in system. The steroids did increase muscle movement and strength.  Pt indicated this to the MD office and wanted to try and wait to see if improved. 11/20/2002 finished steroid. Pt had hoped that all of the pain would be gone by now and the fact is: that is has not. 11/22/2002. pt will go get a second opinion.