chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had a case of shingles in the evening after first dose of Shingrix was administered. The reporter did not want to give information about patient. No further information was reported. The reporter did not consent to follow-up.
I tested positive for COVID-19 on August 26th, 2022. I had a sore throat was sneezing a lot. The next day I had a fever. I contacted my doctor that Monday, August 29, 2022. My doctor prescribes me Paxlovid and that took away my fever.
Information has been received from a physician concerning his daughter, a 23 year old female who in February 2007, in June 2007, in November 2007 was vaccinated with the first, second and third dose of GARDASIL (lot # not reported), respectively. There was no concomitant therapy. During the interval of the second and third dose she had sexual relations. Recently (in approximately October 2010) the patient experienced vulvar discomfort. The patient saw her gynecologist. A PAP performed within past 2 weeks (in October 2010) test showed LSIL (low-grade squamous intraepithelial lesion). The patient had herpetic vulvar lesions (not condylomata) and had responded to treatment with acyclovir. No HPV (human papilloma virus ) testing was performed. At the time of the report, the patient LSIL persisted. In follow-up, the physician indicated that he was requesting a lot check for GARDASIL (lot # 657872/0515U, expiration date 12-FEB-2010 for one of 3 doses of GARDASIL his daughter received in 2007). He was still trying to obtain the other lot numbers for the other two doses. A lot check has been initiated. Follow information has been received from the patient's physician who reported that the patient had no adverse experience following GARDASIL administration. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Patient complained that she has muscle ache on the right arm at site of injection and thought that it will go away after 2 days. Patient complained that she cannot use that arm to turn on her car and cannot lift arm in general. She stated that there is a knot on the area of injection. I contacted the primary care physician who advised patient to go to the emergency room since it has been so long since the shot and issue. Injection was on 10/14/2017.
Patient did report expected sore arm and general ache, but wanted a report done because she got a tingle and a little burning sensation by her nose and upper lip on the left side.
back pain; toes and hands are really cold; mild dizziness; some chills; joint aches; headache; A spontaneous report was received from a female consumer of unknown age, who received Moderna's COVID-19 vaccine and experienced back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was experiencing back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the  events, back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Child became extremely emotionally distressed.  Screaming, crying, and inconsolable.  This lasted for 20 minutes.  This has happened at least once daily in the past 4 days.  The child has never behaved in this way, to this extent.  This was exceptionally abnormal.
fever/develop fever; Afib; This serious case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever/develop fever) (serious criteria hospitalization) and atrial fibrillation (Verbatim: Afib) (serious criteria hospitalization and GSK medically significant). The outcome of the fever and atrial fibrillation were resolved.   It was unknown if the reporter considered the fever and atrial fibrillation to be related to Shingrix.     It was unknown if the company considered the fever and atrial fibrillation to be related to Shingrix.   Additional Information: GSK receipt date: 16-AUG-2023 The patient had Shingrix in combo with other vaccines.  The patient went to hospital spent several days there, released and was now ok.  The hospital refused to say it was vaccine related. (Rest was unknown). The reporter did not agreed to follow up from GlaxoSmithKline (GSK).
This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 05-DEC-2014, administered by the physician at a health facility, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Only a few days after being vaccinated, on or about 08-DEC-2014, the patient was treated by the physician (same one who administered vaccination) at the same health facility (where he received vaccination) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The male patient has been prescribed valacyclovir (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history, and concomitant medication were not provided. On 29-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and expiration date unknown) intramuscular. On 25-MAY-2016 and 28-JUL-2016, the patient was intramuscularly vaccinated with the second dose of GARDASIL (dose, lot# and expiration date unknown) (product use issue). No adverse event was reported. No product quality issue involved. Additional information has been requested.
lethargic feeling; flu like feelings; back & left arm aches (point of inject)
At about 2 pm after getting the vaccine at about 9:20 on 4/14/2021  I began having severe chills and stabbing pains all around my body including my back and ribs, legs, arms, feet and just all over even my wrists.   My arm  at injection site was very very painful too but the chills and stabbing body pains were the worst and lasted all night long and until the next day at around noon.    I had a short bout of nausea at 7 am 4/15/2021 but it was still the pain from the stabbing chills and body aches that concerned me the most.    I treated the symptoms with Tylenol - 2/500 mg tablets very 6 hours.   The first 12 hours the Tylenol seemed not to help at all. Finally the symptoms began to subside around noon 4/15/2021.
This spontaneous report as received from a nurse via a company representative, refers to a 22 year old female patient with drug reaction/allergy to penicillin. There was no patient's pertinent medical history. On 05-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (strength, dose, lot number and expiration date were unknown). Concomitant therapies included a birth control pill. Then, after she left, the patient called into the office and reported that experienced some tightening of throat. No product quality complaint was involved. The outcome of throat tightness was reported as recovered. The causality between throat tightness and GARDASIL 9 was not provided. Additional information has been requested.
Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. Patient was transported to the nearest Emergency room for further evaluation/monitoring. Patient was given Benadryl 25mg by mouth x1 dose
Initial report received from a health care provider on 14 September 2007. A 43-year-old female patient had received an intramuscular right deltoid injection of ADACEL, lot number C2788AA (lot number invalid) and three hours later complained of a headache, back ache, leg pain, and pain and redness at the injection site leading to an emergency room (ER) visit. While at the ER, a lumbar puncture was performed, results were pending at the time of the report. Darvocet and Motrin were administered as corrective treatment and the patient was discharged. The patient's medical history includes allergies to Vibramycin, Morphine, Vicodin, and Augmentin. At the time of the report, the patient was listed as recovered from the event. This case is linked to case 2007-03155 and 20007-03156 which were received from the same reporter.
2nd Moderna vaccine Larm  02/11/2021 Dizziness and lack of balance  resulting in a fall and slight memory loss for the event and disorientation of time for several minutes following the event on  a morning in  April 2021.  This was immediately followed by an evaluation in ER of Medical Center for the remainder of that day. There was a follow up visit  with primary MD within a fee days.  Injury treated was abrasion to L arm.
Information has been received from a physician concerning a 5 year old male who was vaccinated with a second, 0.5 ml, dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently, the patient experienced 10 to 15 lesions. Unspecified medical attention was sought. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
This case was reported by a physician, via a GSK representative and described the occurrence of vomiting in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). Four days after vaccination with ROTARIX, the subject experienced vomiting. At the time of reporting the outcome of the event was unspecified. At the time of reporting the outcome of the event was unspecified. The vaccination series with ROTARIX was delayed.
Swollen lymph nodes; Weakness; Flu like symptoms; This spontaneous case was reported by an other and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), ASTHENIA (Weakness) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 on 15-Feb-2021. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe.).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes), ASTHENIA (Weakness) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and ASTHENIA (Weakness) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Information has been received from a physician concerning a 16 year old female who was vaccinated with Gardasil. It was reported that the patient sat in the room for 10 minutes after receiving the vaccination and when she went to stand up she fainted. They took her to the waiting room to sit for a bit and when she went to stand up and leave she fainted again. The patient sought unspecified medical attention. No other information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 11 year old (previously reported as a 16 year old) female student, with no pertinent medical history, who on 12-JUN-2007 at 13:30 was vaccinated IM in the right deltoid with a first dose of GARDASIL (lot # 657868/0523U). Concomitantly with a second subcutaneously in the left arm of VARIVAX (lot # 657449/0597U), a first dose IM in the left deltoid with of BOOSTRIX (lot # AC52B011CA), a first dose IM in the left deltoid of HAVRIX (lot # AHAVB162D9), and a first dose IM in the right deltoid of meningococcal vaccine (unspecified) (lot # U1968AA). On 12-JUN-2007 at 13:35 the patient went to get up and became disoriented, developed pallor and was syncopal for a few seconds. (Previously reported as the patient sat in the room for 10 minutes.) It was reported that the patient awoke and unaware of what happened. Her total heartbeat count was reported as 78 and the blood pressure measurement was 92/60. The patient waited 15 minutes, then went to leave and was syncopal again for 3 seconds. She waited 30 minutes and then ambulated fine. On 12-JUN-2007, the patient recovered from being disoriented, pallor and fainting. Additional information is not expected.
On 10/8/99, the pt's right deltoid and right upper inner arm was red with a whelp. The symptoms persisted for seven days. Treated with Claritan.
The day after the Flu shot, I experienced dizzy spells. These lasted 1.5 days.
PRESENTED IN OFFICE WITH >50 LESIONS :DX:VARICELLA. BROKE OUT X 48 HRS AGO. ITCHING ,WATERY LESIONS
On 9/29/18, patient stated that she has been experiencing pain on left arm since she received SHINGRIX injection. (SHINGRIX received on 6/27) She stated she had swelling and pain on the area after injection. Swelling went away, and has seen improvement on pain, but still having difficulty lifting her left arm.
In AM he started with uncontrolled blinking and squinting. Occasional twitching of his mouth.
Fever the night of, and body aches, vertigo, dizziness, nausea for three weeks after and running. Extreme mental fogginess, difficulty concentrating, or functioning at all.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JUL-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
dverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. ON 9/21/22 @ 1330     Medications: No current outpatient medications on file.    Allergies: No Known Allergies   Medical history: No past medical history on file.  This was vaccine dose 1 of the FLU VACCINE vaccine.   Describe adverse reaction: DIZZINESS AND FAINTED. Employee was monitored for 60 minutes.   Anaphylaxis symptoms: Dizziness, FAINTING  Anaphylaxis plan: emergency care. The patient was transported to the emergency department. NO ED RECORDS SEEN indicate emergency care included NO ED RECORDS SEEN. Hospitalization was not required  Vasovagal symptoms: dizziness/FAINTED/FELL  Vasovagal plan: offer water  Administration error: NONE   Transferred to Emergency Department and PERSON WHO BROUGHT PATIENT DOWN TO ED.  report number: ***  Email sent and patient documented in adverse reaction
The vaccine is causing Bell's palsy; The first shot actually gave me, every lymph node has swollen in my body and I ended up in the ER; there was a problem and then ended up getting Bell's palsy 2 weeks later; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 19Mar2021 13:00 (Lot number: EN6207) on right arm as single dose for COVID-19 immunisation. The patient medical history included plaque around the heart, nothing else and Covid-19 on 11Feb2021. Prior Vaccination (4 weeks prior) no other vaccination. Concomitant medications included Nadolol, Trazodone, Atorvastatin, Cyclobenzaprine from an unspecified date to unspecified date and unknown indication. It was reported that that the vaccine was causing bells palsy 2 weeks later from first shot. The first shot gave him, every lymph node has swollen in his body and he ended up in the ER; he thought he have a heart attack and that was the first time there was a problem and then ended up getting bells palsy. Due to this patient was hospitalized (tried to think it was Monday 2 weeks ago, 3 weeks ago Monday). In the hospital had blood work and found out that he has bells palsy so, three Monday back from this last Monday he thought this was the Monday right before the Memorial day (further not clarified hence not captured in tab). The patient was treated with Prednisone and the Meclizine. The outcome of the events were unknown.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 25-JAN-2016 the patient was administered with a dose of improperly stored oral ROTATEQ (lot# L013203 and expiration date 28-JAN-2017, dose, dose# and route not reported) and RECOMBIVAX HB (lot# L027733 and expiration date 13-SEP-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information it not expected since there was no consent for follow up contact.
Nausea from 3/26 at 9pm - 3/27 until about 9pm.  Vomiting middle of the night at 327 at 0215.  Took Tylenol 3/27 AM.
This case was reported by a healthcare professional via a sales representative and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with Boostrix (GlaxoSmithKline). On 4 May 2011 the subject received 1st dose of Boostrix at 0.5 ml in an unknown arm. On 4 May 2011, less than one day after vaccination with Boostrix, the subject experienced extreme arm pain and insomnia due to arm pain. At the time of reporting the events were unresolved.
(L) arm swollen, hot-to-touch, hard-to-touch, very red. Temp 97.5.
PATIENT RECEIVED TDAP INJECTION ON 10/23/08.  PT STATED SHE HAD NO PROBLEMS UNTIL 11/01/08 WHEN SHE NOTICED THE INJECTION SITE WAS RED/PURPLE WITH SMALL WHITE SPOTS ON IT.  PT STATED THAT SHE NEVER FELT ANY PAIN/DISCOMFORT ASSOCIATED WITH IT.  SHE RETURNED TO CLINIC ON 11/04/08 TO HAVE THE AREA LOOKED AT AND AT THAT TIME, THE INJECTION SITE AREA WAS SLIGHTLY PINK APPROXIMATELY 1 INCH IN DIAMETER AND WAS NOT WARM TO THE TOUCH.  PT STATED THAT IT WAS GREATLY IMPROVED FROM 11/01/08.  CALLED PT TODAY, 11/06/08, AND PATIENT REPORTS THE AREA IS BACK TO NORMAL.
Shakkyness; Dizziness; Felt some kind of weakness in hand; This spontaneous case was reported by a health care professional and describes the occurrence of TREMOR (Shakkyness), DIZZINESS (Dizziness) and ASTHENIA (Felt some kind of weakness in hand) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced TREMOR (Shakkyness), DIZZINESS (Dizziness) and ASTHENIA (Felt some kind of weakness in hand). On 27-Jul-2021, TREMOR (Shakkyness), DIZZINESS (Dizziness) and ASTHENIA (Felt some kind of weakness in hand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  Within few minutes of receiving the vaccine patient experienced dizziness, shakiness, and some kind of weakness in the hand. Paramedics were called at the pharmacy and they evaluated the patient. The vitals were normal, and patient refused to be transported to the hospital.