chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Inappropriate schedule of vaccine administered; Information has been received from a registered nurse, concerning a female patient of unknown age. The patien''s pertinent medical history, concurrent conditions, and concomitant medications were not provided.  On unspecified dates (reported as in the second dose schedule), the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosage, route, lot number and expiration date were not provided) for prophylaxis.   It was reported that on 23-JAN-2020, the patient was inadvertently vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R029507, expiration date on 10-JUL-2021, dosage and route were not provided) (Inappropriate schedule of product administration), for prophylaxis. No additional adverse events were reported.
Known history of vasovagal syncope following prior phlebotomy and vaccinations. Following administration of his seasonal influenza vaccine today at 1012 patient experienced an episode of vasovagal syncope and was unresponsive for 10 minutes; during this time he exhibited varying episodes of myoclonic jerks and tonic-clonic activity which resolved spontaneously. No loss of bowel or bladder control. No signs/symptoms consistent with an immediate hypersensitivity/IgE-mediated systemic reaction and his vital signs remained unremarkable and stable during this time. He regained consciousness and was alert and conversant following this episode. He was observed for 60 minutes and was stable and asymptomatic at discharge from the clinic at 1025 today.
No additional AE; a 4 year old patient received the PROQUAD and VARIVAX concomitantly; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 15-AUG-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (strength, dose, route of administration, lot#, and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: W003818, expiration date: 02-FEB-2024, product circular#: uspi-v210-i-fro-2303r722; strength, dose, and route of administration were not reported) concomitantly for prophylaxis (overdose). No additional adverse events (AE) were reported (no adverse event).
Expired Engerix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (expiry date 31-JUL-2022) for prophylaxis.   On 25-APR-2023, the patient received Engerix B. On 25-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-APR-2023 As per reporter lot number was not available.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up for safety team. The patient received an expired dose of Engerix-B, which led to expired vaccine used.
initially there was redness, warmth, swelling and tenderness at injection site.  Rash spread to neck and torso then to lower extremities. Throat irritation and swelling occurred with airway obstruction within an hour Treatment rendered in the ED for anaphylactic reaction
Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.
Severe tinnitus after a few days in left ear mostly.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er 87 3u) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), hydrochlorothiazide/losartan potassium (HYZAAR) and atorvastatin (MANUFACTURER UNKNOWN); all for unknown indications, from an unknown date and unknown if ongoing. On 05Apr2021 at 12:00, the patient experienced severe tinnitus after a few days mostly in the left ear. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken as a result of the reported event included treatment with CIPRODEX for ear from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe tinnitus after a few days in the left ear was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of "FLUMIST got in the corner of a two year old's eye" was from a licensed practical nurse concerning a 24-month-old male. The patient's medical history and concomitant medications were not reported. On 20-Oct-2009, the patient was administered FLUMIST. The patient was already screaming, and his eyes were shut when the nurse went to administer FLUMIST to the second nostril. Then the patient moved his head and some of the vaccine went to the corner of his eye. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
After 2nd Pfizer COVID shot. Individual experienced weakness and no appetite. Went to PP 7 days later and was subscribed an antibiotic and steroid. 2 days later experienced shortness of breath and chest pains. Admitted to hospital 6/24/21, mass located in right lung. Biopsy completed but inconclusive. Individual released from hospital 6/30/21 to rehab facility. Released from rehab facility 7/24/21 to home with home health care. Another biopsy was completed which was inconclusive but samples are in petrie dishes and we are waiting for results. Individual is now scheduled for thorencotis. Individual was completely independent before the 2nd shot.
Large, 11.5 x 13.5 area of erythema left thigh. Slightly warm to touch.
sore arm; muscle aches; chills; shakiness; nausea; vomiting; fatigue; fainted; headache; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (for tolerance, refer case US2019178966).   On 25th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), headache, muscle pain, chills, tremor, nausea, vomiting and fatigue. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, headache, pain in arm, muscle pain, chills, tremor, nausea, vomiting and fatigue were recovered/resolved.   It was unknown if the reporter considered the fainting, headache, pain in arm, muscle pain, chills, tremor, nausea, vomiting and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and within six hours started to experience headache, muscle pain, chills, shakiness, nausea, vomiting, fatigue and fainting spells. Less than 3 months after vaccination, the patient experienced sore left arm. It took a couple of days for the adverse events to resolve. The reporter consented to follow up.
Unable to move or walk. Severe headache, nausea, and pain through out my entire body. Increased heart rate. Very thirsty, constantly drinking water or Gatorade. Sharp pains on my side and abdomen. This has all been going on since 6:30pm last night with a fever and chills as well. Also have a slight rash all over my body.
Ears started ringing a few days after my second anthrax shot (Mar 28, 03) and have continued to.  I've also had a dull ache in the ears and the lower back portion of my head.
After both injections I developed wheezing and shortness of breath which led to chest x-rays at Urgent Care.  Doctor prescribed fluticasone HFA 110 MCG/ACT Inhaler.  I was still on the inhaler when I had the second vaccination, so symptoms did not show up until after I ran out of the prescription.  Before I got a refill (delayed in the mail) the symptoms became extremely severe.  Treatment for that visit was as follows: 2 AIRWAYINHALATION TREATMENT Procedures   ALBUTEROL SULFATE .O83% INJ Immunization/Injection,  ALBUTEROL SULFATE .O83% INJ Immunization/Injection
At around 1:30 am the patient started having fever, chills, muscle pain, headache.  She took dayquil. She was not able to go back to sleep  until around 5.30am that she took melatonin. Symptoms continue, except for the fever which now is 97.7 F. Headache, muscle pain and flu like symptoms are quite strong.
Frontal and occipital headache; lasted for 2 and a half days intermittently Injection site soreness which lasted 5 days total (worse on 2nd day but then started to improve)
Severe sinus pressure (pain behind eyes), severe congestion (mucus, phlegm), GI disturbances (excessive gas, flatulence), sore throat
PT REPORT PMH OF SEVERE REACTION TO TDAP VACCINE AT AGE 3. SYSTEMIC REACTION BUT NO ANAPHYLAXIS TODAY REPORTS SHE WAS IN IN BED NOT FEELING WELL FOR 17 DAYS AFTER GETTING 1ST DOSE (WEAKNESS, FATIGUE) PT ASYMPTOMATIC FOR SECOND DOSE UNTILL SHE STOOD UP FOR D/C AND HER HEAD "FELT HEAVY" AND HE KNEES "FELT WEAK".  NEGATIVE ORTHOSTATICS ASYMPTOMATIC AT D/C  VITALS: HR58, RESP18,BP144/87, O2SATS100%
Abnormal vaginal bleeding (3 weeks earlier than her expected period); Abdominal cramping; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding (3 weeks earlier than her expected period)), ABDOMINAL PAIN (Abdominal cramping) and MYALGIA (Sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) 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. In July 2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping) and MYALGIA (Sore arm). On 30-Jul-2021, the patient experienced VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding (3 weeks earlier than her expected period)). At the time of the report, VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding (3 weeks earlier than her expected period)), ABDOMINAL PAIN (Abdominal cramping) and MYALGIA (Sore arm) outcome was unknown.        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 relevant concomitant medications were reported.  No treatment information was provided.
My thyroid antibodies have jumped from 195 to 1434. I ended up in the emergency room 6/23/21 with pelvic pressure, exhaustion, swelling, nausea and vomiting, vaginal dryness, depression and my period came a week early.
Client received Janssen Covid Vaccine on 05/16/2021 at 10:32am. At approximately 5pm reported diarrhea which lasted for approximately 2 hours and went to the local hospital. Client was admitted and inpatient for 3 days.  Cause of diarrhea was undetermined and patient was released.
It started with a head ache, dizziness then my whole body started to ached, diarrhea, vomiting, fever 102., chills, no appetited,  lasting 9 days. Drank water, chicken  broth. I did report it to my Doctor and I recently found out he did not document the event. He advised me to take Vitamin C,  Zinc, and Vitamin B3. I also tried calling the number provided several times no one answered and  never received a call back. I also did one of these forms don't know if it was ever received.
N83.201 - Unspecified ovarian cyst, right side abdominal pain
I started with a headache,nausea that progressively got worse on Tues. I went to ER exp sharp pain behind left eye ear, left jaw was tightening during pain of the headache.
Sore lymph nodes/ on armpit of injected arm; ongoing  Injected arm is sore; less than 24 hours
Fever 102, chills, muscle/bone aches, extreme fatigue, headache.  Slept most of March 13/14.  March 15 awoke totally symptom free
Localized injection site reaction, erythema, swelling, soreness, malaise, low grade fever.
My lymph nodes swelled up on my thyroid it was uncomfortable to talk because of it, chest and under my arms. It lasted about 48 hours. Everything went to normal, and that is when I noticed a lump in my right breast that never went away. My chemo treatment starts on November 9th. We're trying to shrink the tumor so that I don't have to do a full mastectomy. I recovered from the swelling of the lymph nodes.
Intussusception; This serious case was reported by a physician via sales rep and described the occurrence of intussusception in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 17-APR-2023, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 26-APR-2023, 9 days after receiving Rotarix lyophilized formulation, the patient experienced intussusception (Verbatim: Intussusception) (serious criteria GSK medically significant). The outcome of the intussusception was resolving.   It was unknown if the reporter considered the intussusception to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the intussusception to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023. The reporter reported that Rotarix first dose given orally on 15 February 2023 with no issues Rotarix 2nd dose given orally on 17 April 2023 and baby developed intussusception on 26 April 2023.  Baby's condition improved after treatment.  The doctor did not sure if related to product.  Either doctor or nurse could be contacted for more information. The reporter consented to follow up.
Mother called, patient had swelling at site.  Rash and fever, nausea.  Give Tylenol and Benadryl.
Had a physical around the same time as second dose of series. 20/15 vision, no complaints. A couple of weeks after, I started to noticed that my vision was blurry and that reading near and far was difficult. Also started to experience chest pain not reproducable to movement/palpation, but to deep inspiration. This was intermittent and not directly correlated to exercise or strenuous activity. This persisted for months. Has improved over past 2-3 months. Also have been experiencing vertigo I never had before. Also intermittent w/o correlation to anything. I also noticed throughout the follwoing several months that exercise was at times more difficult. One day could not run 4 miles w/o stopping for breaks. Other days I 10-12 miles w/o difficulty. This continues to this day. Vision disturbances also continue to this day. Visited my eye doctor and no major issues discovered during exam. Vision disturbances are intermittent as well. Some days I can see clear, other days very difficult to read signs especially in low light situations.
fever, pinpoint xanthemia, regional lymphadenitis 10 days p/vax;self limited;resolved;
This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 18-NOV-2017 the patient was vaccinated with improperly stored dose of VAQTA (lot # N008823, expiry date 26-MAY-2018), in the right upper arm for prophylaxis. VAQTA was unsupported. The vaccine had underwent a temperature excursion of 31 degrees Fahrenheit during 37 hours and 30 minutes. No adverse effects were reported. Digital data logger was involved and no product quality complaint was involved. There was no previous temperature excursion reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1712USA000569.
In the evening after vaccinations that morning, the child developed redness, heat, swelling, and pain to the left arm where PCV-13 shot was given. Child was seen by provider and Mother was told that reaction was an allergy to the vaccine and returned to the health department for VAERS reporting.  Redness and heat observed on  left deltoid extending to the child's elbow with child guarding his arm.
Cough, back aching, trunk of body aching. Hurt to take a breath! Patient considered going to Emergency Room. Took some Ibuprofen and after about 30 minutes the aching was better, went to bed. The next day patient felt like had flu like symptoms and was "off their mark" at work.
Pt. was vaccinated on 2-4-03 she has had a history of some knee pain, after vaccination this knee pain increased and she also began experiencing significant pain in her hips. This pain increased in severity she saw a Dr.on 2-17-2003, he gave her Darvocet for pain and perscribed physical therapy 2 times per week. The physical therapy made the pain worse so this was discontinued.She continues to experience farily significant hip pain more on the L side, she feels like the pain intensity is increasing which alarms her, she is unable to sleep through the night due to the pain. She also experiences pain and pulling sensation if she sits for very long. Excercise has been difficult. She also has experienced dyspnea on exertion which is new ( e.g. carrying a load of laundry up the stairs). She plans to call her Dr. Today and go back in since she is not better.
Patient presented to clinic approximately 1 month after injection. The patient had a persistent lump and bruising at her injection site. Treatment is supportive, with warm compress daily. Patient will f/u if not improving. No pain, no weakness, and no numbness.
Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of the injection), and mouth ulcers (underlying condition occurring 2-3 times a year, I was NOT in a flare up at the time of the injection). For the Uveitis I went to my eye doctor and started a prednisolone regimen and am still on it. I received the 2nd does (lot EL9264) yesterday on 3 Feb at 09:00am. The mouth ulcers were treated with oral medication-Valtrex. 2nd dose does not seem to have aggravated the above noted reactions. Other symptoms common to the injection are occurring but seem more intense after the 2nd dose (aches, low energy, some minor coughing)
This will seem trivial in terms of reactions, but my period came 9 days early. If my cycle was a country, it would be Germany because my internal trains run on time without fail. However, the morning of 3-23-21, my period started. It is so out of the ordinary and I have become aware that I'm not the only woman with this issue after receiving the vaccine.
Inappropriate schedule of vaccine; Lethargy; Sore arm (L); General feeling of unwellness; Muscle Aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of lethargy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On 07-JUL-2023, the patient received the 2nd dose of Shingrix (left arm). On 07-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). In JUL-2023, the patient experienced lethargy (Verbatim: Lethargy), pain in arm (Verbatim: Sore arm (L)), feeling unwell (Verbatim: General feeling of unwellness) and muscle pain (Verbatim: Muscle Aches). The outcome of the lethargy, feeling unwell, muscle pain and drug dose administration interval too long were unknown and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the lethargy, pain in arm, feeling unwell and muscle pain to be related to Shingrix.  It was unknown if the company considered the lethargy, pain in arm, feeling unwell and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter was the patient. The reporter gave consent to follow up with healthcare professional (pharmacy). The reporter did not consent to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
pt devel pruritic rash through to be hives-3-4hr p/vax;persisted <24hr;resolved;hives were on back of neck & legs;there was also local swelling, erythema & pruritus @ the site of inj which persisted longer;
site pain, swelling x days 1-3; HA, fatigue x day 2; herpetic whitlow x day 7 and up to 3 weeks post dose. Narrative:
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 19 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1821286 and expiry: 20-MAR-2022) dose was not reported, 1 total, administered to left arm on 24-AUG-2021 for prophylactic vaccination. The patient experienced administration of refrozen vaccine following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A and expiry: 20-MAY-2022) dose was not reported, 1 total, administered to left arm on 27-JAN-2022 for prophylactic vaccination. Age at time of vaccination 19 years old. No concomitant medications were reported. On an unspecified date, the vaccine was refrozen (Dose number in series 2) and on 27-JAN-2022, the patient experienced administration of refrozen vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, involving the same patient is linked to 20220537507. This case, from the same reporter is linked to 20220538428, 20220538573, 20220538480, 20220538149, 20220538379, 20220539045, 20220540611, 20220538693, 20220540435, 20220540524, 20220540474, 20220538890, 20220538347, 20220540853, 20220541180, 20220538292, 20220537683, 20220538316, 20220540688, 20220540642, 20220540765, 20220540420, 20220540814, 20220540816 and 20220541085.
CDC reports: 17 mo child developed fever to 102, generalized rash, hives & edema following immun. Treated w/Benadryl, Epinephrine S.C. & susphrine SC. Lasted 4 days.