chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Fluarix intranasally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 18-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3SE27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intranasal) and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route.On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the nurse. The nurse supervisor called in to report and stated clinical staff inadvertently administered Fluarix intranasally to a patient instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow-up.
Information has been received from a physician concerning his medical assistant's 15 year old daughter with seasonal allergies who on the "last month" in August 2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication reported. The same night post vaccination the patient experienced nausea but no vomiting. Next day post vaccination the patient developed a "severe headache" which lasted for 3 days. The patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
pt recv vax & devel a breakthrough case of chickenpox w/30 to 50 papules & vesicles;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2011, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a medical center for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a consumer concerning her 3 year old son with no pertinent medical history or allergies who on 27-AUG-2008 was vaccinated with his first dose of MMR II (lot# not available) in the arm. There was no concomitant medication. On 03-SEP-2008 "1 week after receiving the vaccination" the patient experienced rash under his arms and a fever. The patient recovered from the rash " less than a week after the rash appeared." No labs or diagnostic studies were performed. There was no product quality complaint. (Consumer declined demographic information or her son's physician's information). No further information was given. Additional information has been requested.
General Achiness in both arms, back, knees and chest. Taking aspirin. Little relief.
Patient received a COVID-19 vaccine at the COVID vaccination clinic. The vaccines were shipped. addressed to 2 Soldiers who were hosting the vaccination clinic. The vaccination were alarming in transport. the Soldiers were advised that the vaccines were no longer viable and should not be given to the patients. Due to a lack of and miscommunication, 5 patients received the vaccines.
LOSS OF APPETITE; MILD/SHARP PAIN IN STOMACH; CONSTIPATION; GASTROINTESTINAL PAIN; HEAD PAIN; A LITTLE SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, sharp/mild pain in stomach, constipation, gastrointestinal pain, head pain, and a little sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, sharp/mild pain in stomach, constipation, gastrointestinal pain, head pain, and a little sore at injection site. This report was non-serious.
24 hrs following vax pt devel lump on the posterior neck & swelling in the lt lateral supracalvicular area; dx cervical adenopathy; As of 3OCT90, pt had not improved & as of 8NOV90, condition of the pt is unk;
Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast,  loss of appetite, difficulty breathing, vomiting and nausea.  The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three  times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate.   On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.).  On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F.  In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2.   The outcome of the events, pain coming from around the liver area radiating under right and left breast,  loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
1 month post vax: Swollen Right Breast  Acute Nerve Pain in upper ab/chest Breathing difficulty - splinting  Fatigue Arm weakness - can?t make fist Right ear pain  2 month post vax (add): Lower spinal cord pain Muscle weakness right leg, right ankle, right forearm Right diaphragm difficulty breathing Neuralgia upper right chest Fatigue  Unstable balance
no adverse effects; patient was administered VARIVAX and PROQUAD on the same day; Information has been received from a nurse regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 11-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, lot # S019461, expiration date 24-JUN-2021, for prophylaxis. On the same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscularly, lot #S006830, expiration date 02-SEP-2020, also for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.  The outcome of inappropriate schedule of product administration and the causal relationship between the event and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were not reported.
I woke and had a sore throat and it kept getting worse. I had a slight fever and a light cough so I took a come COVID test and it was positive.
Information has been received from a nurse referring to a 10 week old patient. On 27-FEB-2015 the patient, who was indicated for a dose of hepatitis B vaccine, was vaccinated with a dose of VAQTA injection (lot # reported as K010912, expiration date 13-NOV-2015, dose and route not reported) in error. No adverse effect was observed or reported. Additional information has been requested.
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago in 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The pharmacist informed that a patient had just received the 2nd dose of Shingrix. The health care professional (HCP) did not specified dates of administration. No more details could be obtained since call disconnected. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
I got the shingles and had gotten the shots/ suspected vaccination failure; I got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: I got the shingles and had gotten the shots/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient got the shingles and had gotten the shots.  The patient was told that it would had been worse if he/she have not had the shots. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Pain in arm-first day; swelling and hives, noticed morning of 4/13/2010; called advice nurse morning of 4/14/2010; took ibuprofen and Benadryl - symptoms lessened.
A LITTLE NUMBNESS IN WHOLE LEFT ARM; STARTED FEELING HOT DUE TO HOT FLASHES; ACHING A LITTLE BIT AROUND LEFT SHOULDER; ARM FEELS A LITTLE MORE SORE THAN USUAL; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and arthritis, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609) dose was not reported, administered on 24-MAR-2021 10:15 AM on Left Arm shoulder for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, and diclofenac for pain, and arthritis. On 25-MAR-2021, the subject experienced numbness in whole left arm. On 25-MAR-2021, the subject experienced started feeling hot due to hot flashes. On 25-MAR-2021, the subject experienced aching a little bit around left shoulder. On 25-MAR-2021, the subject experienced arm feels a little more sore than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aching a little bit around left shoulder, numbness in whole left arm, and arm feels a little more sore than usual, and the outcome of started feeling hot due to hot flashes was not reported. This report was non-serious.
LEGS BEGIN TO FEEL HEAVY AND HAD TROUBLE GETTING INTO CAR AND WHEN GOT HOME COULD BARELY GETTING INTO HOUSE WITHOUT HELP.
experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001a21a and 037a21b) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Product used for unknown indication, PRAVASTATIN, LEVOTHYROXINE, MONTELUKAST, LOSARTAN, DILTIAZEM, ALBUTEROL [SALBUTAMOL] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced NASAL DISCOMFORT (experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL DISCOMFORT (experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning) outcome was unknown.            Patient  states that on October or September their nasal passages were burning and went to the doctor them antibiotics and these happened twice.   This case was linked to MOD-2021-368964 (Patient Link).
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 04-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
I can not taste or smell the same. Toothpaste, rice, onions, coffee and many other things do not smell and taste quite right.
Pt. received MCV/TRUMENBA yesterday; started feeling nauseous with body aches after getting home had mild  slurring of speech and anxiety by evening (leg numbness tingling of extremity); went to bed usual time and woke up at 3AM; had near syncope episode that time; no LOC went back to bed after doing better now, talking good, no nausea no dizziness and beginning to feel better.
Pt was given influenza vaccine on 10/17/03 then noted to have some reddness and swelling of the right thigh around the vaccination site on 10/18/2003.  Parents spoke with doctor on call that day and then came in for office visit on 10/20/2003 as instructed.  She continued to have a swollen/red/hot/tender right thigh with surrounding the vaccination site.  Pt did have some limping in the first couple days but otherwise was acting and playing normally.
Has lost 15 pounds; Unable to eat; Either has diarrhea or vomits right away; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Has lost 15 pounds), FEEDING DISORDER (Unable to eat) and VOMITING (Either has diarrhea or vomits right away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (Has lost 15 pounds), FEEDING DISORDER (Unable to eat) and VOMITING (Either has diarrhea or vomits right away). At the time of the report, WEIGHT DECREASED (Has lost 15 pounds), FEEDING DISORDER (Unable to eat) and VOMITING (Either has diarrhea or vomits right away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Action taken with mRNA-1273 in response to the event was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-086413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086413:Case for Daughter
4PM recvd flu shot; 8AM sudden onset stiff neck & numbness & tingling lt hand; which cont today
Excessive bruising, diagnosed with ITP, platelet count upon admission 14,000. Treated with IVIG.
6-1/2 hours later:  Symptoms came on quickly.  Hands and feet felt frozen, chills, severe shoulder joint and muscle pain.    Immediately had to lay down and took Advil/Tylenol.  Could feel the movement of joint pain from shoulders to elbow, hips to knees.  Headache.  Couldn't navigate stairs safely.   In bed or on the couch for 24 hours until 6pm Friday 4/9/2021.      Three of us from the same company had the Janssen Vac within a day of each other and all 3 of us had the same adverse reaction.  To me, that is not mild symptoms when it debilitated me and kept me from going to work.    Most family members have had Pfizer with two shots and had NO side effects.
Was fine the night before. Woke up and his eyelids were swollen and his lips were swollen. Immediately, my wife called Telehealth and described the situation. They said to get him some Benadryl and we gave him that. He also had a headache - we might have give him a Tylenol. With Benadryl - he took four or five doses according to the protocol on the Benadryl. He did not go to school. The next day, he was swollen but not as bad. My wife bought him Claritin and he didn't do anything because he didn't know which to take (Benadryl or Claritin). His swelling went away quite a bit that day without taking anything and he went back on Wednesday -there was still a little bit of swelling but not much. He wasn't feeling great though that whole week. He was still tired and was a bit headachy until Friday or so. Somewhere on the weekend he felt back to himself.  He is due for second vaccine this weekend and we aren't going to have him take it then. We're concerned and have decided to hold - the physician said he shouldn't have had a COVID vaccine two weeks before this Pfizer one (he received the Varicella) on the 29th of April- -Dr said  it should have been a month  or so of waiting  still before  he had this vaccine after that.
Normal side effects the next few days: chills aches  extreme tiredness. The above side effects got milder but persisted for more than two weeks. Also, I would wake up drenched in sweat every night for more than two weeks. Also my sense of taste is altered.  I had no problems during the entire pandemic. Had I known of the above side effects I probably would not have gotten the vaccine.
Crying w/leg pain; unable to walk; saw PMD 02OCT92; worried about nerve damage; 03OCT92 t100, x-rayed; 06OCT92 pt improved-needle didn't hit bone-"walking"; PMD was very concerned about hip joint infection;
Information has been received from a registered nurse, concerning a 20 year old female patient, who on 12-JUL-2007 was vaccinated with the second dose of Gardasil (Lot # not reported). There was no concomitant medication. On 12-JUL-2007, after receiving the vaccination, the patient felt like fainting, though she "did not lose consciousness." The nurse confirmed that the patient recovered on the same day, 12-JUL-2007. Additional information has been requested.
Patient reported a non-painful rash that lasted 4-5 weeks after the injection with a raised/slightly swollen area where the shot was given. Patient reported that the swollen area resembled a bug bite.