chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; 1st dose on 13 Sep 2022, 2nd on 13 Oct 2022; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th October 2022, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and drug dose administration interval too short. In October 2022, the patient experienced feeling bad. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling bad to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The reporter was the patient who reported she received her first Shingrix vaccine on arm and her second Shingrix vaccine on left deltoid.  The patient started to feel like she had the flu-like symptoms through-out the night and less than a week after vaccination, was still feeling bad today (reporting day).  The patient realized she was given the dose early because she went online and saw the recommended dosing schedule.  The patient reported when she called the pharmacy the pharmacist said a technician gave her the vaccine, the technician was not aware of the dosing schedule when the caller told her she received the first Shingrix vaccine one month ago and the scheduling system must had failed.  The patient gave permission to follow-up with health-care professional. The consent to follow-up was granted. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Information has been received from a physician concerning a 7 year old Semitist female who on 06-Dec-2002 was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient was on concomitant therapy but no medications were listed. On 03-Apr-2003 at 1000 the patient developed a mild case of chicken pox that the physician described as breakthrough varicella disease with greater than 30 pox/vesicles on the first day (also reported as less than 50 breakthrough lesions). On day 1 the patient was afebrile. No prescription drug treatment was required. Medical attention was sought and on 03-Apr-2003 it was reported that the patient's experience is still being treated. Additional information has been requested.
Patient notified nurse that he was due for a second Shingrix. The nurse gave him a dose of Shingrix. Once this was given and entered for billing, it was discovered this was actually a third dose. Pharmacist in charge was notified. Staff contacted the facility in which the patient lives and spoke with the charge nurse. She stated the patient had not experienced any side effects and even asked the patient while on the phone. Staff also notified the patient's primary care physician.
Flu-like symptoms:  headache, fatigue, muscle aches, chills, and fever.
p/vax (2 days) sx of elevated fever, swelling of glands internal & external difficulty swallowing & some resp compromise; given APAP #3 for pain; bed rest;
Got Flu shot 10/12/05 at 11:00 am. At 3:00 am severe pain woke me up and arm ached like I hit it with a hammer from shoulder to wrist and sick feeling all over, legs ached and weak nausea, chills and sick feeling in stomach. Woke up 4 hours later and pain better put still feels effects of this flu shot. Woke up sick every morning and weak legs with headache. Not allergic to eggs.
very bad flu like symptoms, couldn't breathe, congestion . stiil down , been 1 1/2 weeks .see dr. on thur ,6/24 follow up .
PAIN FROM BACK TO LEG AND BOTTOM OF FEET THEN AROUND STOMACH; NUMBNESS FROM BACK TO LEG AND BOTTOM OF FEET; DIFFICULTY IN STANDING UP STRAIGHT AFTER SITTING; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included back pain, and other pre-existing medical conditions included the pain that patient experienced is different from the pain that the patient had in back. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-JUL-2021, the subject experienced pain from back to leg and bottom of feet then around stomach. On 13-JUL-2021, the subject experienced numbness from back to leg and bottom of feet. On 13-JUL-2021, the subject experienced difficulty in standing up straight after sitting. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain from back to leg and bottom of feet then around stomach, and numbness from back to leg and bottom of feet, and the outcome of difficulty in standing up straight after sitting was not reported. This report was non-serious.
Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Headache).  The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Arexvy.     It was unknown if the company considered the headache to be related to Arexvy.   Additional Information: GSK receipt date: 09-OCT-2023 This case was reported the patient via interactive digital media. Follow-up not possible as no contact details provided.
severe cramps in calf's and thighs; cramps as bad as bruises and calf's bruise; This is a spontaneous report received from a contactable consumer (patient). This 62-year- old male patient received his 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) at single dose via an unknown route in left arm on 09Apr2021 for Covid-19 immunization. Medical history included anxiety. Concomitant drugs included cariprazine hydrochloride (VRAYLAR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clonazepam for anxiety. Patient had been having severe cramps in calf's and thighs in Apr2021. Patient had a shot on "Friday" and it started "Tuesday" (also reported as "may be 12 or 13Apr") night. Patient had been having cramps as bad as bruises and calf's bruise and the muscles "that are lined". No treatment received. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Muscle aches and stiffness (besides injection site), nausea, chills, vomiting, loss of appetite, crying for no reason. Arm pain.
The pt complained of joint pain in right ankle, both knees, left arm elbow area and left shoulder blade. The pt also complained of of a pimple like rash appearance on face, neck and chest, accompanied by itching.
Child had immunizations at 10 AM 11/2/2005 - Fever started at 10:30 PM according to the ER on 11/03/2005 - Was 10:56 when they arrived in the ER at 4 am 11/4/2005 - CBC, BI culture done.
Right upper quadrant with area of 3cm x 2.5cm induration and erythema. Area is non-tender vs stable. Area noted PM 6/11/03.
Moderate dizziness 24/7.   Worsened numbness and tingling in fingers (existing MS symptom  got worse)
This spontaneous report as received from a nurse refers to unknown number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with improperly stored PEDVAX (strength, dosage, frequency and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Swelling of eyes and face, beginning approx 30 min after vaccine administration along with large red whelps and rash from head to toe.  Benadryl given and pcp notified. Swelling began to decrease at 7 pm, rash began to fade around 10 pm. Child ran fever of 103 the next day that was controlled with Motrin and Tylenol alternately. Child is currently rash and fever free.
left sided numbness, drooping in face and problems with speech. Went to ER, possible Bells Palsy.
I had the virus this past July; I had the virus this past July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset Jul2021, outcome "unknown" and all described as "I had the virus this past July".  Additional information: Reporter queried for to get more information on your trial, and possibly participate in it. Reporter stated that she had the virus this past July and she passed it on to her husband as well. Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101743024 same reporter/AE/SD, different patient
ALLERGIC REACTION (RED RASH ON FACE AND TINY BUMPS AND WAS BLOTCHY); This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included: insomnia, and ibs, and concurrent conditions included: seasonal allergies, allergy to dogs, allergy to penicillin, marijuana abuse (approx 4 times per month), alcoholic (1 drink per day average), and smoking (approx 5 cigarettes per month). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 30-APR-2021, the patient experienced allergic reaction (red rash on face and tiny bumps and was blotchy). Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction (red rash on face and tiny bumps and was blotchy). This report was non-serious.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Patient stated that she felt bad after she received the vaccine. On 2/21 she stated to experience a high heart rate of 200 beats while laying down. She was also experiencing high blood pressure. She is a very active person who monitors her vitals. Her heart hate is as high laying down as it is when she works out. The went to the ER bc they were concerned about blood clot concerns. They kept her over night to monitor her while receiving medication. Was released and told to follow up with a cardiologist. Went on 2/02/2021 to see the cardiologist. The cardiologist did another EKG. Patient stated that she is back on track after about four weeks. Patients also stated that her electrolytes was off balanced.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. The patient reported that she relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced her to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered the event to be related to zoster vaccine live(ZOSTAVAX).
Went for normal prenatal ultrasound at 11weeks 4days pregnant at OB office and found that my baby was only measuring  8weeks 3days  which is when i recieved my H1N1 vaccine!!!  I suffered a missed miscarriage and had to have a d&c because of it. 12/1/09 medical records received for DOS 11/13-12/1/09 OB telephone notes. Final DX: Fetal demise, partial hydatidiform mole.  On U/S fetal demise at approx 8 weeks.  Previous ultrasound at initial visit showed fetal growth appropx 1 week behind.  Molar pregnancy. D&C.
Patient died on 4/22/21.  Vaccinated with 2nd dose of Moderna on 3/31/21.  Vaccinated with Shingrix on 4/15/21.
On 02/27/2023 I tested positive for COVID-19. I was really tired, slept a lot, cough, runny nose. I had a telehealth visit and provider prescribed Paxlovid.
Hives/Welts on abdomen from chest to lower abdomen developed first Sunday night; throughout the next day more developed on legs and arms and around back.  about 1/2 inch by 1/4 inch, very itchy.  Took Benadryl Monday night and it did little to relieve the itch.  into Tuesday night itch is down slightly, hives still same size and redness.
8PM - body aches and chills  10:15pm to 11:30pm - uncontrollable body spasms/jerks. Heart rate increase and unable to talk normally. One word per spasm. Ended up having MS flare up from this reaction and still recovering from that.
Myalgia & Fever Narrative:  Employee reports experiencing fever and body aches by the evening  time after receiving the second dose of vaccine. Reports using ibuprofen for symptom relief (no dose/frequency/duration provided). Employee has since recovered and is doing well.  Other Relevant History:
Red-itchy-warm to touch-rash over entire upper arm- shoulder pain and swelling radiating down arm- Referred to family doctor. Pt is 31, she got an MMR II of her left arm at the health department earlier today, and presented here complaining of having a reaction with swelling, pain, shortness of breath. On presentation her blood pressure is 130/80. She doesn't have any angioneurotic edema. Her lungs are clear. Cardiac rhythm is regular without murmurs, rubs or gallops. She has some erythema and swelling at the site of the injection site that is fairly impressive looking. She is given 25 of BENADRYL, and 60 of KENALOG IM, and observed and did well. She was instructed to take BENADRYL 25 mgs. q4 hours for the remainder of the night and recheck as needed for any problems. M.D.
Approximately 5 days after receiving influenza vaccine administered at High Schoolf, pt. began experiencing  pain in that arm, radiating to forearm and up through shoulder into neck.  After some time, a rash began to develop on his arm.  At this point I took him to the doctor.  I explained that he had a flu shot a few days before these symptoms began, and asked if it is possible that it is related.  The doctor immediately closed the door on that question and was unwilling to discuss it.  He stated that there is absolutely no possibility that a reaction of this type can or could be related to a vaccination.  He diagnosed either HSV or Shingles, and insisted that this condition was caused by "stress at home".  This is ridiculous.  He is a well-adjusted, happy teen in a stable, loving, nearly-stress free home situation.  Two days later the test came back showing Shingles.  I have since become aware that indeed many healthy, young adults who are at otherwise extremely low risk of Shingles outbreaks have had this exact same experience. It took two courses of Acyclovir and several weeks for his shoulder, arm and neck pain to subside.  Three months later he is nearly back to pre-vaccination condition.
This spontaneous report as received from a pharmacist refers to a 63 year old non-pregnant female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. None drug reactions/allergies were reported. On 06-MAR-2017, the patient was vaccinated with a dose of properly stored ZOSTAVAX (for prevention of shingles, lot # M035696, expiration date 07-NOV-2017, subcutaneously; dose was not reported) reconstituted with properly stored sterile diluent (subcutaneously, lot # reported as M016886, expiration date 07-DEC-2018; dose was not reported). On 15-MAR-2017, the patient experienced tuberculin (TB) test like bump at the injection site. The patient sought medical attention via calling the pharmacist. No treatment was given for the adverse event and none lab diagnostics studies were performed. The outcome of TB test like bump at the injection site was reported as recovered on an unknown date in 2017. The relatedness between the adverse event and the suspect therapies was not provided. Additional information has been requested.
RECEIVED SECOND DOSE OF MODERNA COVID VACCINE; ON 21JAN21 @ 1800 HRS, SYMPTOM ONSET INCLUDES FEVER, MUSCLE ACHES, MUSCLE SORENESS (BOTH BODILY AND AROUND THE SITE INJECTION), TENSION HEADACHE, AND CHILLS/SHIVERS  SYMPTOMS RESOLVED OVERNIGHT. RESIDUAL SYMPTOMS INCLUDE SLIGHT FEVER, SLIGHT HEADACHE, AND SLIGHT CHILLS THE NEXT DAY
Pt recvd vax & 1-2 minutes following became weak & began sweating, pt exp hypotension, dizziness, abdo cramps & became flush;
Client says almost immediately after taking the vaccine she started having blurry vision, face and throat started burning, and her throat started closing. She was given Benadryl 50mg IM  After 10minutes her symptoms resolved except for a rash on her body. She was released to a friend to drive her home. She reports taking Benadryl 50mg every 4-6 hours for 48 hours afterwords.
Vaccine Kinirix was drawn up to give to patient and administered. LHD notified clinic and asked if this was correct and it was. Incident report was complete and LHD is taking care of their part.
Syncope (possible seizure) lasted 10 seconds, second event of syncope 30 minutes later
No signs or symptoms reported. No other AE or PQC reported.; Improperly stored administered vaccine (7.52 F); This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot #T027304 was confirmed to be valid, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 7.52 degrees Fahrenheit for 6 hours and 4 minutes. There was nor previous temperature excursion. No additional adverse event was reported. Sender's Comments: US-009507513-2108USA006754.
Red, raised lump with tenderness at site of injection slightly itchy.  Denies shortness of breath or hives.  Advised to apply ice to site use Tylenol or advil for discomfort; come in for ice pack if she chooses.
No additional adverse effect reported; on unspecified date on or after 3/23/2020, a patient  received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 23-JAN-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose detail, lot # and expiration date were unknown) orally for prophylaxis.          On approximately 23-MAR-2020 (reported as on or after 23-MAR-2020), the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose detail were unknown; lot # 1660146 and expiration date 20-OCT-2020) orally for prophylaxis. The vaccine was exposed to temperature excursion at above 47 degrees Fahrenheit (59.7 degrees Fahrenheit) for 6 hours and 1 minute (incorrect product storage). There was multiple previous temperature excursion at above 47 degrees Fahrenheit (53.2 degrees Fahrenheit) for 7 hours and 38 minutes. The call was due to digital data logger. No additional adverse effect was reported.
After vaccination patient felt light headed, heart rate increased, and chest heaviness. EMS was called and she was left in her own care. EMS called it as Anxiety attack.
At 4 pm on August 22, 2023 a headache underneath my occipital bone began.  I used tylenol low dose about every 4 hours.  These headaches were with me for 2 weeks most of the day and night.  When I would wake up in the middle of the night to urinate, I took another tylenol.  After the first 2 weeks the headaches under my occipital bone became less frequent.