chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs reported; Varivax was administered during temperature excursion; Information has been received from a nurse concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 28-DEC-2020, the patient was vaccinated with a temperature excursion (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot No. T014309, exp. date 24-APR-2022) (route of administration not reported) for prophylaxis. No adverse evenst reported.  Temperature: 12F Time frame: 30 minutes Previous temperature excursion: No Call because of data logger.
Fever up to 102.8 for two days, freezing, sweating, all of my joints hurt, horrible headache, so sleepy!!!
SM developed redness, swelling, pain approx 24 hrs after receipt of anthrax vaccine.  Swelling Start: 12/16/2007; Erythema Start: 12/16/2007; Edema @ injection site 50-120mm Start: 12/16/2007; Pain Start: 12/16/2007
PT here for 2nd dose of Pfizer, received at 1440. At approximately 1450, PT presented with diaphoresis, pallor, and reported that he felt hot and had slight nausea. No LOC noted. PT was able to walk to cot without difficulty, laid down on cot at 1451. VS at 1452: BP 102/68 laying, HR 94, SPO2 100% RA, RR 18. No respiratory distress noted. PT accepted and drank juice, reported he felt ?a little better? laying down. PT reported that his first dose went well and he doesn?t have a history of similar reactions after vaccine.  VS at 1458: BP 104/84 laying, HR 83, SPO2 99% RA. Education provided to PT and mother on vasovagal reactions, when to seek out medical care. At 1500, PT sat up, reported that he ?feels good? and self-transferred to chair without difficulty. Pt reported the nausea is resolved, color is visibly improved, diaphoresis is resolved. VS at 1500: BP sitting is 112/88 sitting, HR 89, SPO2 99% RA. PT was able to stand at 1509, reports he felt ?great?, was talking with RNs and mother with affable demeanor. VS at 1509: BP 98/72 standing, HR 88, SPO2 99% RA, RR 18. PT denied dizziness, stood without difficulty and walked with steady gait. At 1513, PT exited facility with mother. Mother reported that she will stay with PT today to monitor him.
One week after receiving the second shot of the Covid vaccine I experience severe dizziness, weakness in my body and loss of coordination. The symptoms slightly improved next weeks but never went away. On Friday October 8th I was seen my PCP. Since my laboratory results were fine he said I should be getting better soon. On October 13th I got extreme weakness in my legs , dizziness and nervousness. My PCP prescribed Lorazepam because he thought I was stressed (I took only one pill, it made me "high" so I did not take the pills). Unfortunately I still feel my legs fatigue even after short walks. The dizziness is not so bad but the weakness in my legs is still present.
I received my first shot on 3/30/21 and still have arm pain running the length of my arm and armpit. I received my 2nd dose on 4/29/21. My arm is still achy all the way to my fingertips today (5/4/21).
This spontaneous report as received from a registered nurse refers to a 18 months old patient of unknown gender. On 23-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Parasthesia/pain at site of injection that's lasting persistently since vaccinated in 04/2021 and comes and goes in severity.
BELLS PALSY; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's weight was 200 pounds, and height was 72 inches. As patient's medical history, patient's blood pressure was elevated when he went to the hospital, patient had been a non-smoker and drinks alcohol (As socially, patient would drink his beer). The patient had no known allergies and did not have any drug abuse or illicit drug use. The patient had no known medication regimen. Patient's mother has diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-AUG-2021, the patient had numbness and tingling on the right side of his face with pain behind his right ear. It worsened through the day and later in the evening he was sent to the local hospital. Upon arrival at the hospital he was diagnosed with Bell's Palsy (G51.0). Patient had a neuro check on the patient and his Glasgow Coma Scale/Score (GCS) score for eye opening was 4, verbal was 5, with right sided numbness. In the discharge documentation comments, it said right sided numbness, paralysis. Patient had no fever and no eye pain, also denied hear ache pain and denied chest pain. No apparent distress, can close his right eye 80 percent - 7th nerve palsy on the right. For treatment, patient received Prednisone 60mg and Zovirax 800mg in the emergency room (ER). Prescriptions that were given to take home were Acyclovir 200mg, dispensed 50 pills to take 1pill 5 times a day and Prednisone 20mg, dispensed 10 pills to take 1 orally twice a day for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210902915-covid-19 vaccine ad26.cov2.s -Bells palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
It sent her blood sugar through the roof; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration in Jan2021 as single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus. It was reported that she have type 1 diabetes for 53 years. The patient's concomitant medications were not reported. She stated that last week she got the shot and on an unknown date it sent her blood sugar through the roof. She is wondering what is in the product that would increase her blood sugar.The event was considered as non serious.The outcome of the event was unknown.
Off balance, tingling in legs and feet, weakness in legs, eyesight compromised when doing physical activities, problems with hands being able to grip things.
Pt was sitting in vehicle during observation period post vaccine. Complained of lightheadedness. Was laid back in seat. HR 40's. BP 40's. Pale appearing and diaphoretic.  Alert and oriented. Complained of feeling weak.  HR remained low. Bp remained low. EMS called. 20 ga L AC PIV started 0.0% NaCl IVF 200ml administered and patient was sent to emergency department per EMS for evaluation.
Beginning approximately 2 weeks following my COVID booster, I began experiencing heart palpitations, bradycardia, syncope, chest pain - was found to be in Bigeminy and was started on Metoprolol after a hospitalization for heart dysrhythmia. Arrhythmias continued , so Flecainide was started. I'm still struggling with the heart arrhythmia and intermittent chest pain.  I now see a Cardiologist and take two heart medications.
Patient  experience extreme pain in the left arm of the injection site for a week and  pain in the top of head immediately after injection was completed.
Swelling of one side toward back of tongue lasting approximately 45 minutes - no treatment sought; symptoms resolved without medical intervention.
Morbilliform rash developing 2 days after PREVNAR vaccine, with larger area of erythema surrounding vaccine injection site. No signs of secondary infection or severe allergic reaction.
FAST HEARTBEAT; DIZZINESS; TROUBLE SLEEPING; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced trouble sleeping. On MAR-2021, the subject experienced weakness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fast heartbeat, dizziness, weakness and trouble sleeping was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
NONE - REPORTING ERROR: PATIENT RECEIVED A 0.3ML DOSE OF PFIZER VACCINE THAT WAS MIXED WITH 0.8ML OF SALINE RATHER THAN 1.8ML OF SALINE, HUMAN ERROR ON PHARMACY PART OF PERSONNEL RECONSTITUTING VACCINE; PATIENT INFORMED ON 05/26/21 2:17PM OF VACCINE ERROR AND INSTRUCTED TO WATCH FOR ABNORMAL OR GREATER THAN NORMAL SIDE EFFECTS.
Sweating,  body aches,  chills,  heart palpatations, stomach cramps,  rash on my upper torso that look like tiny red small strawberries  weakness and headache. Took some benadryl. Stayed home 3 days  in bed to get myself together.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Within the hour I felt dizzy. I had a headache that continued to go on until the following day, which I noticed the right-side of my face swelling. I had a fever, body aches, chest tightness and shortness of breath. It felt as though I had COVID-19 all over again. This continued for over a week: fever of 102, body aches, chills, headache, chest tightness and shortness of breath. Still currently having shortness of breath and chest tightness.
red swelling under the injection site; hurts under the injection site; tired; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), VACCINATION SITE PAIN (injection site hurt), INJECTION SITE SWELLING (red swelling under the injection site) and VACCINATION SITE PAIN (hurts under the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (tired) and VACCINATION SITE PAIN (injection site hurt). On 01-Apr-2021, the patient experienced INJECTION SITE SWELLING (red swelling under the injection site) and VACCINATION SITE PAIN (hurts under the injection site). On 24-Mar-2021, FATIGUE (tired) and VACCINATION SITE PAIN (injection site hurt) had resolved. At the time of the report, INJECTION SITE SWELLING (red swelling under the injection site) and VACCINATION SITE PAIN (hurts under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported. No concomitant medication was reported. No treatment medication was reported.
Intermittent chills; Sweating; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. 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 COVID-19 vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); both for an unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jan2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021 at 05:00, the patient experienced intermittent chills, sweating and fatigue. The effect lasted from 18 hours after vaccine to approximately 66 hours after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events intermittent chills, sweating and fatigue were recovered on an unknown date in Feb2021.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
Patient was sitting for the required 15 minutes after getting the shot, then started calling for us as she was passing out. We laid her on the floor and she came to after a few minutes, she was talking normally, no trouble breathing, described feeling of "being dead", but we laid her on the bench after that and the EMTs came to her aid thereafter.
complaint of weakness, FATIGUE, NAUSEA, DIARRHEA, HEADACHE, NO APPETITE
Got Shingles, occurred w/o rash.  Shingles pain.  Shortness of breath.
14April23 I started having a scratchy throat and a cough. The next day I was whizzing and it got worse . I am coughing and tremendous fatigue and blowing my nose a lot. I called the doctor and she gave me albuterol inhaler , prednisone , codeine cough syrup and benzonatate.  I still haven't recovered. She said it might be a virus.
Moderna covid 19 vaccine EUA..  I have all side effects for last 5 days since the shot.  Fatigue, bad headache, muscle pain, chills, sweats, nausea, vomting and fever.  Never been this sick, ever ever.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-DEC-2007 the patient was vaccinated with ZOSTAVAX, 1DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patent to contract a persistent strain of shingles. On or about 13-FEB-2014, the patient was treated at a Rheumatology and Arthritis Center for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster (shingles).  The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
The mother of a 10-month old male reported that her son received his first injection of Prevnar on 3/17/00. The next day he developed a red rash on his torso. He was treated wit Benadryl and recovered.
Patient was administered a second dose of Hepatitis A too early. PT had no adverse side effects or reactions. VAERS is being submitted due to administration error only.
A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 24-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Feb-2010, the patient was administered FLUMIST. 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.
I got shingles from the vaccine/Suspected vaccination failure; I got shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles from the vaccine. Additional supportive information: 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. The follow-up could not be possible as no contact details were available.
Tachycardia; Fever; Insomnia or trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Shingrix. On 8th February 2022, less than a day after receiving Shingrix, the patient experienced insomnia. On 9th February 2022, the patient experienced tachycardia and fever. The patient was treated with paracetamol (Tylenol (Acetaminophen)). On an unknown date, the outcome of the insomnia, tachycardia and fever were recovered/resolved.   It was unknown if the reporter considered the insomnia, tachycardia and fever to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced insomnia or trouble sleeping that evening. Next day during dentist appointment, he was found to have tachycardia and fever. All the symptoms were resolved. The patient took Tylenol 500mg as a treatment for fever as suggested by his healthcare professional. Consent to follow up was granted.
Large Grape Sized Bump at Injections Site with Swelling, Red Rash and Heat
11/13/21 12:30 PM headache began, pain in frontal lobe and sinus. Headache gradually intensified and at 12:50 PM approx. projectile vomiting 2x. Paleness after vomiting and  chills.   11/22/21 approx 7:15 AM first menstrual cycle began. Currently, still in menstrual cycle with very light flow.
May 10th I had a stuffy nose but I had just recently tested myself for Covid on May 8th and was negative. May 11th, I still had a stuffy nose and in the middle of the night I woke up with a bad, dry, hacking cough that brought tears to my eyes for about half the night. May 12th, I tested myself again at home and was positive. That same morning, I called my doctor's office and they said to treat symptoms with over the counter medications. A few hours later they called back to inform me that they were prescribing Paxlovid. I took my first dose that evening. I had my last dose this morning. The symptoms have begun to dissipate but I do have a lot of fatigue that will come and go still.
Both kids had significant swelling at site of  injection and fever; Both kids had significant swelling at site of  injection and fever; redness/swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Both kids had significant swelling at site of  injection and fever"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness/swelling".  Additional information: The office has a photo of the redness/swelling.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231496 same reporter/drug/AE, different patient;
Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a contactable nurse (patient).  A 31-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number EK9231), intramuscular on 29Dec2020 16:30 at single dose on left arm for COVID-19 immunization.  Medical history was none. The patient's concomitant medications included OTC Vitamins/Supplements.  No allergies to medications, food, or other products. The patient experienced lightheadedness x 3-4 hours until after eating a full meal on 29Dec2020 16:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.