chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got panicky; Panic attack; could not breath; lungs felt heavy; no appetite, then a large appetite; felt dehydrated; soreness in arm; not feeling well; itching at a base of skull; rash on stomach; could not sleep; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (could not breath), DISCOMFORT (lungs felt heavy), INSOMNIA (could not sleep), PANIC REACTION (Got panicky) and PANIC ATTACK (Panic attack) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037AZIB) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE and MAGNESIUM for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced INSOMNIA (could not sleep), OROPHARYNGEAL PAIN (sore throat), DEHYDRATION (felt dehydrated), PAIN IN EXTREMITY (soreness in arm), MALAISE (not feeling well), PRURITUS (itching at a base of skull) and RASH (rash on stomach). On 25-Apr-2021, the patient experienced DYSPNOEA (could not breath), DISCOMFORT (lungs felt heavy) and APPETITE DISORDER (no appetite, then a large appetite). On 26-Apr-2021, the patient experienced PANIC REACTION (Got panicky) and PANIC ATTACK (Panic attack). On 25-Apr-2021, DISCOMFORT (lungs felt heavy) had resolved. On 26-Apr-2021, PANIC REACTION (Got panicky) and PANIC ATTACK (Panic attack) had resolved. At the time of the report, DYSPNOEA (could not breath), INSOMNIA (could not sleep), OROPHARYNGEAL PAIN (sore throat), APPETITE DISORDER (no appetite, then a large appetite), DEHYDRATION (felt dehydrated), PAIN IN EXTREMITY (soreness in arm), MALAISE (not feeling well), PRURITUS (itching at a base of skull) and RASH (rash on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Valerian Root Tea , Magnesium
Experienced runny nose and coughing day after the shot and still continues to have the same problem. Shot was administered on 10/31/05.
02/20/22 presents to ED for "right femoral shaft fracture" "after fall while skiing". PMHx of "hypercholesteremia"
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Vomiting; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema, vomiting and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, vomiting, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema, vomiting and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group of the patient selected as an adult, because the patient was reported as employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck, vomitting and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 3 of 9 linked cases reported by same reporter.
Information has been received from a registered nurse concerning female "over 60 years of age" who, on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed an injection site reaction with redness, swelling, and tenderness. The reaction was treated with cool cloths and ADVIL or TYLENOL for pain if needed. The patient was seen in the office. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Patient admitted to hospital,  from her rehab facility for AMS and slurred speed after a recent hospitalization for COVID.  She had an MRI which was negative for new CVAs.   Initially her mental status started to improve with supportive measures and IV fluids.   Her hospital course was com/plicated by A.fib /with RVR which EP was consulted, she was resumed carefullyo on systemic anticoagulation with Eliquis and fortunately did not show any s/s of recurrent GIB. EP was debating whether or not she was stable enough for TEE/DCCV; however she developed worsening confusion and hypoxemic respiratory failure. Repeat chest imaging showed signs of multifocal PNA.   Admitted to hospital, and respiratory status continued to decline.  Patient was made DNR/DNI.  She went into asytolic arrest and expired on  09/15/2022.
Upper right arm erythema and induration (1.5in x 2in); Upper right arm erythema and induration (1.5in x 2in); This is a spontaneous report from a contactable physician. This physician reported non serious events. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced upper right arm erythema and induration (1.5in x 2in) on an unspecified date with outcome of unknown.
This spontaneous report was received from a licensed practical nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 17-APR-2017, the patient was inadvertently vaccinated with a partial dose of PROQUAD subcutaneous injection (dose and frequency were not reported) lot # M035143 with expiration date of 30-JAN-2018, that was reconstituted with diluent MRK (lot # M029682 with expiration date of 12-JAN-2019), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Dull ache area of shot.  Severe pain when muscle is stretch as in raising are up. Increasing more pain all day. Took 2 Aleve with minimal relief.
This patient is an 89-year-old man with dementia.  He comes from dementia unit.  He had some exposure to COVID, had some mild upper respiratory symptoms, and was diagnosed with COVID about 5 days ago.  He is fully vaccinated.  The daughter is at bedside and gives history.  Apparently, he has been having increased falls this year for about the last 2 weeks.  He was brought to the emergency room today after he fell and had laceration to his face that required suturing.  He apparently has gotten up and walked to the nurse's station while here because he is confused, but not far from baseline that he has unsteady gait, we have been asked to admit him to the hospital.  Appears that he had been started on dexamethasone at his dementia unit, it looks like he may be started a couple of days ago.   DISCHARGED 01/18/2022: This patient is an 89-year-old man with dementia.  He comes from dementia unit.  He had some exposure to COVID, had some mild upper respiratory symptoms, and was diagnosed with COVID about 5 days ago.  He is fully vaccinated.  The daughter is at bedside and gives history.  Apparently, he has been having increased falls this year for about the last 2 weeks.  He was brought to the emergency room today after he fell and had laceration to his face that required suturing.  He apparently has gotten up and walked to the nurse's station while here because he is confused, but not far from baseline that he has unsteady gait, we have been asked to admit him to the hospital.  Appears that he had been started on dexamethasone at his dementia unit, it looks like he may be started a couple of days ago.   Did well with PT, vitals stable, on room air and CXR w/o infiltrates.  Daughter agreeable with return to Facility, in fact would prefer he go back today as his dementia worsens when out of  his usual environment.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (6 year old patient received vaccine from a 6 months to 5 year vial) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (6 year old patient received vaccine from a 6 months to 5 year vial). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (6 year old patient received vaccine from a 6 months to 5 year vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that the patient does not have any allergy, the patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The reporter stated that a 6-year-old patient at one of the clinics came in for a well child visit. During that visit the patient received the Moderna COVID-19 Vaccine. After the vaccine was administered it was discovered that the patient was given 0.5mLfrom the Moderna vial that was intended for those aged 6 months through 5 years. The reporter was reaching out to determine next steps for the patient if the patient need to restart the vaccine series, or to continue with the 2nd dose in 4-8weeks. The patient had received COVID-19 Moderna 50mcg/0.5mL. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Follow up received included anatomical location of vaccine administration was added and narrative was updated.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to -15 degrees C) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of Health Agency and Health Clinic. The regulatory authority website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
A 71 year old male pt was treated for bladder cancer with Oncotice since 7/3/06. Before his second instillation, blood wad found in the urine after catherterisation (not due to the caterisation procedure). Reportedly he experienced flu like symptoms (achy lower abdomen, thigh and lower back pain, low grade fever, intermittent brief episodes of hot flashes with diaphoresis) and therefore the second treatment with Oncotice was withheld. As of 7/17/06, his temp had gone down and visually his urine had cleared.
Spiking high fevers on Tuesday, Wed 12:15 PM seizures; admitted to hospital, at 1:30PM second seizure (different type); Pt admitted to PICU.  Decreased platelets, decreased WBC, increased % Lymphocytes, decreased % neutrophils, increased liver enzymes.  Thursday: hepatosplenomegaly, further decrease of platelets and increased of lymphocytes, spiking of fever continues. Friday: As a result of blood values, bone marrow performed.  Sat: fever broke and red rash developed, platelets decreased  to 43,000. Cardiac eval: echo cardiogram showed dilated left coronary artery Sunday: platelets increased 87,000, no fever, pt discharged from hospital. Monday: results of flow test: showed 28% immature cells, blasts and hematogones. Tuesday: Blood values improving, platelets increased, WBC 7,400, lymph still elevated, neutrophils still decreased, liver enzymes still elevated.  Patient in process of being monitored by neurology, cardiology and hematology.
Pain at injection site starting immediately after injection, achiness, chills, headache, fatigue starting approx 12 hrs after injection, lasting approx 30 hrs. Treated with ibuprofen and Tylenol.
No adverse effect; patient was administered the M-M-R II intramuscularly; This spontaneous report was received from a pharmacy intern referred to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N032747 and expiry date 20-NOV-2019, route of administration via intramuscular for an unknown indication(incorrect route of product administration) and no adverse effects reported (no adverse event). Action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was discontinued on 10-MAY-2019. No PQC found.
moderate body aches, headache, chills, possible low-grade fever. soreness and swelling at the site.   No rash that I can see.  I will definitely live, but thought it best to document.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a parent via a company representative concerned a 55 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number and expiry date were not reported) ) 1 total, dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination which was an off label use, and inappropriate schedule of vaccine administered (dose number in series 2).  The batch number was not reported and has been requested. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to .
HAD BEEN INJURED BY VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had been injured by vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had been injured by vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211051962 and 20211052814.
I was lightheaded an hour or so after the shot. The following two days 4/22+23 I had a severe headache behind my eyes. I took approximately 1000-1500mg of tylenol each day to try to relieve the symptoms but it didn't work very well. The headache went away by day 3 but then I had some occasional twitching in my left leg on and off over the course of an hour and some stiffness in that leg especially behind my knee. I then had a dead arm on my left side with tingling in my finger tips and left side of my tongue. I rested all day 4/24+25 and by Monday 4/26 I was feeling better. I spoke to my doctor and we thought I should talk to an allergist to see if I should take something prior to my second dose. I am currently feeling completely fine and healthy 10 days later.
Shot 12 months after the second shot; This case was reported by a consumer via media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received shot, 12 months after 2nd dose, which led to extra dose administered. The reporter asked, was this sequence still effective.
This spontaneous report received from a patient via social media via a company representative concerned a 90 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very little red at the injection shot (dose number in series 2). It was posted that "I am 90 years old has all the shots and booster never had any reaction to any except for a very little red at the injection shot." The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very little red at the injection shot was not reported. This report was non-serious.
I had basic chills for the first few hours. My arm ached for about a day. I noticed in April that my glands in my neck were swollen. It was in the middle of my neck on the left side. I went in to see my PCP for a different issue and had her look at it for me. She told me that it was my lymph nodes. I had an ultrasound done on my neck where the lymph nodes are.  She also did a blood test, but that came back normal. The report says that there are swollen lymph nodes in the left lateral neck.
Fever which went up to 104 degrees. His eyes became infected, needed medicine. Heavy breathing. Weak, loss of appetite.
Showed a nurse who works at the clinic when they were golfing, (L) arm red. We called her the next day states size of softball, red warm, and itching. States is better today.
9yo F patient accompanied by her mother and father here to receive the first dose of Pfizer COVID vaccine. Approx. 10min after vaccination patient was feeling "nauseous". She denied any other symptom. Mother reports that the patient has a PMH of intermittent asthma which has been well controlled, she also claimed that the child was a little nervous about getting the vaccine. Patient was evaluated by on-site EMS and MD; noted to be AAO x3; Initial VS: HR 82, RR 16, SpO2 100%, BP 100/66. Patient was kept on observation sitting down on the stretcher, she drank water. Approx. 20min after, the patient felt better, repeated set of VS remained within normal limits. Discharged home with complete resolution of symptoms......
Tingling in right leg-whole leg; Leg also feels heavy and weak; Leg also feels heavy and weak; Left temporal headache; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 27Apr2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included REM sleep behavior disorder (RBD) sleep disorder, attention deficit hyperactivity disorder (ADHD) and chronic sinusitis. The patient had known allergies to shellfish and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); both taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took ondansetron (ZOFRAN), metoclopramide (REGLAN) and lamotrigine (LAMICTAL); all for unknown indications and experienced drug allergy. On 27Apr2021 at 15:45, the patient experienced tingling in right leg-whole leg, leg also felt heavy and weak, left temporal headache and confusion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in right leg-whole leg, leg also feels heavy and weak, left temporal headache and confusion was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was administered a dose that was beyond the known stability of 6 hours for the vaccine; it was likely 15 to 18 hours beyond known stability period.
I have a major herpes simplex 1 outbreak on my lips and chin.- I usually get 1/2 a year.  I have 8/9 major spots all bigger then any I?ve ever had.  And they usually start to subside after the first day.  These are getting bigger through the 3rd day.  If I could attach a couple pics you would see its not just a minor issue.