chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lethargy; nausea; sore arm; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 73-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route of administration on 03Mar2021(at the age of 73-years-old) at 11:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthmatic allergies and known allergies to sulfa, penicillin, molds, pollen, nuts. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), levocetirizine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 since the vaccination. The patient experienced joint pain, lethargy, nausea, sore arm on 03Mar2021. The patient did not receive treatment for reported adverse events. The clinical outcome of the events joint pain, lethargy, nausea and sore arm was recovered on an unknown date in Mar2021.   No further information is expected. Information about lot/batch number cannot be obtained.
Patient given vaccines (Td, MMR and Varicella) on 6/21/07. Patient called 6/25/07 - states had a reaction to the chickenpox vaccine - began with fever and generalized achiness - developed rash. Went to Urgent Care on 6/23/07  was told has chickenpox.
obese 35yoM who presents with acute SOB which was found in the ED due to acute COVID 19. He is diaphoretic, and speaks in only short sentences, frequently expressing varying preference for BPAP or facemask. He received the Moderna vaccine series several months prior, and had been in his usual state of good health prior to the abrupt onset of symptoms. He takes medication for hypertension.  DISCHARGE DIAGNOSIS: 1. Acute hypoxic respiratory failure secondary to COVID- 19 pneumonia 2. COVID- 19 pneumonia with super-imposed bacterial pneumonia 3. Sepsis secondary to above on pressor support 4. Obesity with body mass index 57 5. Elevated D-dimer He was started on NRB and BPAP, as well as all COVID therapies of steroids, anticoagulation, Colchicine, and Ivermectin. He was also started on broad spectrum antibiotics for possible super-imposed bacterial pneumonia. His oxygenation worsened and he was intubated on 8/8. His O2 levels remained difficult to control and the AM of 8/9 he was proned with increasing PEEP. His oxygenation improved and he appeared to be overall stabilizing by 8/10. The afternoon of 8/10, he was getting suctioned by RT and was noted to become bradycardic, however, this quickly resolved with Atropine and was attributed to increased vasovagal tone secondary to prone positioning and increased PEEP. He remained HD stable and his O2 remained 90s (Last recorded VS HR 61, RR 24, BP 111/67, and O2 99%). Unfortunately, at approximately 2117 the patient developed an irregular heart rate before going into ventricular tachycardia and then asystole. He was started on medical management as per guidelines and CPR was initiated as soon as possible under the direction of Dr. was never obtained and Dr called at 2150. The patient's family was informed of his passing and all questions were answered. Cause of death appears to be cardiac arrest secondary to ventricular tachycardia secondary to hypoxic respiratory failure secondary to COVID- 19 pneumonia.
L Arm extremely painful. June 2021 had surgery on L trigger finger and L thumb.  Both areas of surgery after  injection became inflammed L middle finger and L thumb joint very swollen and painful. It did get better but I still feel discomfort at  times which I had not experienced until after I got the booster injection. If you want to discuss further, please contact me.
Patient was given the wrong dose. She was given 0.5ml of Pfizer instead of 0.3ml. She stayed the 15 minutes. No s/s of adverse effects from receiving the wrong dose was noted.
Pustular rash on forehead,back of neck,lip, and hip.   Headache, fever (100 F) arthralgia, myalgia, malaise, tightness and pain in chest
Temp 103.6 24 hours after vaccine. No irritabililty or lethargy. Pt appeared her usual self.
Redness, warmth to left shoulder about the size of a lid. Has gotten better over weekend.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-DEC-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 670038/0761AA; expiry date 09-APR-2012) on 27-DEC-2012. Route was not reported. No concomitant medications were reported. No adverse effect was reported. No further information was available at the time of report. Additional information has been requested.
Resident received Covid-19 booster shot on 1/28/22 at 1200pm. Resident was found deceased at 0246am on 1/29/22 in his bed. Resident had no complaints or signs/symptoms of adverse reaction prior to death.
No adverse effects after my first or second shot.  Then, about a week and a half after the second shot, I began to experience dizziness.  This eventually led to two terrible (but brief) episodes of vertigo (room spinning wildly out of control).  Have had dizziness and fuzzy head ever since.  Also, am experiencing tinnitus...not so noticeable at times but other times it is quite pronounced.  Can't seem to shake any of these symptoms, though they seem to be lessening a bit each day.  From what I understand, this is happening to many others as well.  Am not sure if blood type has anything to do with it but mine is A Negative.
This spontaneous report as received from a licensed practical nurse refers to a 21 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In January 2016 (exact date not reported), the patient was vaccinated with the first dose of human papillomavirus (HPV) vaccine - GARDASIL, (dose, injection site, route of administration, lot number and expiration date were not provided). On 14-APR-2016, the patient received the second dose of HPV vaccine - GARDASIL 9, lot number L036245, expiration date: 09-FEB-2018, (dose, injection site and route of administration were not provided) (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Headache, slight fever (warm) 98.7, fatifue, nausea, swollen lymph nodes. 2/8/03 - 2/9/03 36 hours no treatment
I could have blood clots; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FA7484) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that: "I could have blood clots" on an unspecified date with outcome of unknown.   No follow-up attempts are possible. No further information is expected.
Administered after temprature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Havrix, Engerix B, Fluarix Quadrivalent 2022-2023 season and Boostrix. On an unknown date, an unknown time after receiving Havrix, Engerix B, Fluarix Quadrivalent 2022-2023 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administered after temprature excursion). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 22-MAR-2023 The physician assistant (PA) called in to add excursion details of the vaccine Havrix, Engerix, Fluarix, Boostrix. The PA reported they administered the vaccines that were exposed to inappropriate temperatures to many patients from 18th September 2022 up to a week ago on 9th March 2023, with Fahrenheit less than 10 minutes. The reporter enquired that should they get revaccinated. The PA unable to provide any vaccine or patient details. The reporter did not consent to follow-up. The patients were vaccinated with vaccine Havrix, Engerix, Fluarix, Boostrix after they were exposed to inappropriate temperatures, which led to incorrect storage of drug.
pt recv vax 3MAR98 & 7 days later on 10MAR98 pt c/o a dull ache in the lt testicle;6APR98 pt had an elevated temp of 101-102;blood chemistries were taken showed elevated enzymes, elevated lymphocytes & dec neutrophils;LDH 334, SGOT 233;
30-year old patient was administered a dose of DTaP instead of Tdap; no adverse reaction occurred; patient notified; verifying with Immunization Action Coalition what patient follow up is required. Contributing to the error are the following: 1. Nurse Practitioner (NP) giving vaccine; NP not as familiar with vaccines 2. Vaccine storage needs to be better organized and labeled; separating adult from pediatric and labeling
pt vax hepta B. pt ex general achiness, and earache.  vaxed w/ 2nd dose w/o adverse reaction
Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient asked that Would a ice pack or heat pack  help with muscle soreness or not.
Moderna Covid-19 Vaccine EUA Chills, headache, body aches, nausea, exhaustion
Received Flu shot 0.25 mg IM on 12/24/15 at 11 am. By evening patient started becoming clumsy. Next day daycare teacher noted clumsiness and tripping. Improved in 1 week.
Attention deficit-hyperactivity disorder; Anxiety; COVID-19; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder), ANXIETY (Anxiety), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate To Severe Adult Crohn's Disease).   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 28-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency. In May 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 30-May-2021, FATIGUE (Tiredness) had resolved. In 2022, COVID-19 (COVID-19) had resolved. At the time of the report, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety) had not resolved.            There was no reported medical history.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Concomitant medications details were not reported.  The reporter's causality for the events of Attention deficit-hyperactivity disorder, Vaccination site pain, Tiredness, Anxiety and COVID-19 was not reported for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624068 (Patient Link).
Information has been received from a health professional who was a 28 year old female with migraine who on 06-FEB-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant therapy included zolmitriptan (ZOMIG) and vitamins (unspecified). On 07-FEB-2007, the patient experienced sweet taste on the surface of tongue the day after vaccination (within 24 hours) which did not last very long. Subsequently, the patient recovered from sweet taste on the surface of tongue. Sweet taste on surface of tongue was considered to be non-serious. Additional information is not expected.
This spontaneous report was received from a Medical Assistant via company representative, referring to a 15 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 30-APR-2018, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) with lot # N022952 and expiration date 14-JUN-2020 for prophylaxis. On the same office visit the patient also was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and TRUMENBA. Medical assistant informed that the patient became dizzy, fell and was caught by patient's father, after receiving the three vaccines, the patient was given water orally, monitored in a second patient room for an unspecified period of time, until patient was fine to go home. At the time of the report, the outcome of fall and dizziness was reported as recovered. The Medical Assistant did not mention the causality assessment between the events and GARDASIL 9.
Patient reported dry mouth and difficulty swallowing at 20 minutes after the vaccination.  The patient was monitored for 5 minutes and then it was determined to call EMS.  EMS arrived about 5 minutes after being called and took the patient to the hospital and assessing the patient.  No epinephrine was administered here at the pharmacy due to patient not presenting with difficulty breathing.
SOB, shaking, loss of voice, nausea, vomiting, diarrhea, headache - Panic attack Red Hot swollen area at injection site
?Covid arm? : Large red rash, soreness, itching on left arm, appeared one week after shot
Itching and redness at injection site (within 15 minutes). Patient took BENADRYL at this resolved the itching.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt felt lightheadness, fell slightly on ground (did not injury head).pt did not pass out/loss consciousness. pt rested with legs ups on chair for 15 mins. Ambulance came just in case to check on pt. vital signs were checked. Pt given ok from ambulance - pt stable.pt provided water and chocolate for energy. Pt started to feel better was monitored for 20 mins more then pt went home. follow up call was made later that day around 7p. Pt stated was feeling much better. No further issues. Pt healthy.
wrong vaccine administered; Foggy feeling; Severe pain on her where the injection site was higher up on shoulder; Felt cold then felt hot then felt cold; arm was swollen and hard to touch; She had big red mark exact straight line right over bicep and back of triceps that encompassed half triceps and half bicep; Could feel cold feeling in back of arm like stuck there; felt weak and fatigued; felt weak and fatigued; had not a a pleasant reaction; arm was hard to touch; This spontaneous report was received from a consumer and refers to a 69-year-old female patient with osteoporosis, arthritis, bundle branch block left and asthma. The patient's medical history included pneumonia. Concomitant therapies included alprazolam (XANAX) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). Historical vaccines included PFIZER BIONTECH COVID-19 VACCINE.  On 30-JUN-2023 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W001100 and expiration date, 0.5 milliliter, intramuscularly in the left arm for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered).  On 30-JUN-2023, 6 hours after injection, the patient had not had a pleasant reaction (ill-defined disorder). First thing she felt was foggy feeling (feeling abnormal). Went to bed because she didn't feel comfortable moving about the house. Felt as if getting cold. Felt cold then hot then felt cold (feeling of body temperature change). Hot one second cold the next. Next thing was severe pain on her where the injection site was higher up on shoulder (vaccination site pain). Pain down top of rotator cuff and that pain was all on her upper arm and it was so painful she could not move her arm, she felt like neurological problem in a way. Pain was off the chart, and she could stand a lot of pain. Took 2 advil. Couldn't use or raise arm above straight out. This was caused by injection. Top of arm in front, not triceps, left of biceps it was hard and swollen, arm was swollen and hard to touch (Peripheral swelling) (Induration). Then more strangely she got like when you wear a t-shirt and get line from sunburn it's opposite that she had big red mark exact straight line right over biceps and back of triceps that encompassed half triceps and half bicep (Erythema). Could feel cold feeling in back of arm like stuck there (Peripheral coldness). Also felt weak and fatigued and like she had to go to bed and control (Asthenia) (Fatigue). The outcome of induration, ill-defined disorder, fatigue, asthenia, peripheral coldness, erythema, peripheral swelling, feeling of body temperature change, vaccination site pain and feeling abnormal was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events was not applicable.   The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
10 hours after my injection I experienced a very high fever, body aches, headache, ears ached...the next day I was sore and extremely tired with headache. Today I feel the same and had a low grade fever last night.
Information has been received from a 63 year old white female consumer with hypertension and penicillin allergy and history of shingles 40 years ago who on 18-APR-2008 was vaccinated subcutaneously with 0.65 ml of zoster vaccine live (Oka/Merck). Concomitant therapy included "a diuretic"(therapy unspecified) and "blood pressure medication" (therapy unspecified). One day post vaccination, on 19-APR-2008, the patient developed blister like eruptions at the injection site and a blinding headache. The consumer also noted that she had started to feel itchy all over her body. At the time of reporting the patient had not yet recovered. Medical attention was not sought. There were no lab diagnostic studies performed. There was no product quality complaint. Follow up information was received from a physician who reported on 18 APR 2008 at 10:00 that patient was vaccinated subcutaneously into the right arm with a first dose of zoster vaccine live (Oka/Merck), (lot # 659326/1824U). It was noted that on 21 APR 2008 the patient called the physician stating that she had sores all over and was very itchy, (previously reported by the consumer as "developed blister like eruptions at the injection site and started to feel itchy all over"). An office visit was scheduled, but the patient did not keep the appointment. There was no illness at the time of vaccination. The patient's status was unknown at the time of reporting. Additional information has been requested.
About 30 hours following injection, observed slow to full facial pain on the right side of face and head. Face was mildly inflamed and in pain for approximately 6 hours, then gradually the pain and inflammation subsided. No ibuprofen or other pain relievers were taken at the near the time of adverse event. Ibuprofen (400 mg) was taken at approximately 9 pm the previous evening to reduce arm pain/pain at the injection site.
Within 5 minutes post administration of immunizations he developed a hivey rash on both legs below knee.  Afebrile, no irritability.  Benadryl 1mL per mouth given-rash improved past 15min.
Pain in entire left arm, pt. having difficulty raising arm & lifting up objects. Getting better slightly but slowly.
Immediately following the injection, felt immediate metallic taste in mouth, warm sensation from head to toe, lightheaded that almost lead to fainting (did not ever actually pass out), tachycardia... this lasted for about 5 minutes.  Later that day I continued to feel flushed and had localized hives that went away on their own.
BODY ACHES; DIARRHEA; FEVER; TIREDNESS; 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: not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, tiredness and diarrhea was not reported. This report was non-serious.
Today's Visit: COVID-19 Pfizer, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (CVX=208)5/2/2021, 4/11/2021 patient received both of her vaccines at clinic Had fatigue and left arm soreness after the first vaccine but this resolved after a few days  Within 8 hours, however, of receiving the second vaccine patient had chills, diaphoresis, tactile temperature and a very sore left arm.  Severe headache and dizziness.  Could not get out of bed for two days.  Poor appetite.  Was able to maintain her hydration.  Beginning on Tuesday had a very painful throat with dysphagia.  Had some breathing.    Seen last night at clinic due to pain and breathing difficulties.Maalox/pepcid and albuterol/decadron.
Pt vax 3rd dose; did not achieve effective titers. 03Apr91 titer indicated non detected.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. On an unknown date, PROQUAD underwent a temperature excursion and was administered to an unspecified amount of patients. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Headache-Medium, Additional Details: Patient presented to the pharmacy one day after the second COVID dose was administered. Patient tolerated the first dose with no issues. Patient had a large rash and blistering at the injection site. We adminstered 50mg of benedryl and instructed the patient to follow up with urgent care.