chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a few seconds after client reported to RN feeling dizzy at 1715. RN set up anti-gravity chair and client was able to transfer without assistance. RN then informed PHN client was not feeling well and prior to vaccine had stated he had a headache. Mother had told RN  client's headache was minor and to still administer vaccine. PHN arrived at 1717, client alert and oriented x4, sitting in Fowler's position, pale. Vitals at 1717: pulse 95, oxygen sat 99%. Per client new onset of nausea and stomachache, RN gave client emesis bag and water. Blood pressure at 1719: 118/76, pulse 75. Per client's Mother, client has medical history of migraines, no current medications and no known allergies. Per client had ate earlier today, but spent all day out in the sun. Client stated his migraines are often accompanied with nausea and vomiting. Client informed he would be kept 30 mins in observation. Vitals at 1724: blood pressure 120/72, pulse 75, oxygen sat 99%. Per client dizziness same, headache slightly improving 5/10.  At 1726 client reported needing to use restroom. EMT guided client to restroom. Client able to transfer self again back to anti-gravity chair. Vitals at 1735: blood pressure 125/76, pulse 78, oxygen 99%. Client reported feeling "slightly dizzy", headache improving and nausea had resolved. Client stayed with EMT remainder of observation. Vitals at 1741: blood pressure 120/78, pulse 70, oxygen sat 99%. Per client headache 3/10, dizziness and nausea resolved. At 1746 client reported mild headache. Vitals at 1810: blood pressure 120/78, pulse 72, oxygen sat 99%. Per client headache same. EMT educated client and Mother to follow up with medical provider and gave ER precautions. Client left facility with steady gait at 1812
just test positive for COVID. She previously received the Pfizer-BioNTech COVID vaccine; just test positive for COVID. She previously received the Pfizer-BioNTech COVID vaccine; This is a spontaneous report from a contactable Pfizer colleague (consumer) reported for a friend. A non-pregnant 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACINNE) on an unspecified date at the age of 40-year-old (lot unknown) as single dose for covid-19 immunisation. No covid prior vaccination. It was unknown if the patient has known allergies. Medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wasn't feeling well (sore throat, fever, headache) and just test positive for COVID post vaccination. She previously received the Pfizer-BioNTech COVID vaccine. This case was reported as non-serious. It was unknown if treatment for the event received. The outcome of the event was Recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Postural orthosthatic tachycardia syndrome; This spontaneous report was received from a consumer regarding a case in litigation, referring to a patient of unknown age and gender. Information about the patient medical history, concomitant medications, drug allergies or reactions was not provided.  On an unknown date,  the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), for prophylaxis (2 doses, scheme , dose, administration route, lot number and expiry date were not provided).  On an unknown date, after the two shots the patient experienced postural orthostatic tachycardia syndrome (POTS).    The outcome of postural orthostatic tachycardia syndrome was unknown.   The reporter considered postural orthostatic tachycardia syndrome to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  This is one o 2 cases from the same reporter.; Sender's Comments:  US-009507513-2303USA007760: US-009507513-2303USA007746:
Felt dizzy, then fainted x 30 seconds, observed x 1 hour. Patient felt normal after waking up.
Pt recv vax on 12/24/98; on 1/5/99 pt expired
This is a spontaneous report received from contactable reporter. The reporter is the patient. A 44-year-old female patient (not pregnant) received bnt162b2, administered in arm left, administration date 08Dec2021 16:30 (Batch/Lot number: unknown) at the age of 44 years as dose 3, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 04May2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 13Apr2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: immunization, pyrexia, chills and lymph node pain. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymph node pain. Additional information: 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 had not been tested for COVID-19. seriousness was no. It was reported that Seriousness criteria- results in death, life threatening, caused/ prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect was no. The lot number for bnt162b2 was not provided and will be requested during follow up.
I did not have any adverse reactions after shot 1.   I had a delayed reaction after shot 2. About 2-3 days after I received the second dose, I had a hard lump and deep bruising at the injection site, and tingling down my arm. It lasted until April 13 (about 6 days). Now it has subsided and there is only a faint bruise at the injection site.   I spoke with the pharmacist/manager of pharmacy where I got the vaccine, and she told me to report it.
After patient received their 2nd COVID vaccine they reported feeling dizzy and then fell down. Per the front end staff they did not hit their head or appear to injure themselves in anyway. We had the patient lie down for 15 minutes after which they stated they were fine. The patient was then instructed to walk around for 5 minutes to make sure they were feeling okay. The patient was then called later at 5pm that day and they reported they were feeling fine.
This case was reported by a healthcare professional and described the occurrence of arm rash in a 23-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 2 August 2013 the subject received a dose of HAVRIX (1 cc, unknown route, right arm). On 4 August 2013, 2 days after vaccination with HAVRIX, the subject experienced arm rash and arm inflammation. The reporter stated that "both of the patient's arm having a rash and becoming inflamed." No other details were known at the time of reporting. The subject was treated with BENADRYL after evaluation from a doctor. At the time of reporting the events were worse. The healthcare professional considered the events were related to vaccination with HAVRIX. Per the reporter, "it was not certain whether the reaction was from the HAVRIX but it was assumed to be since it only started after receiving the vaccine."
In early March I had tremors and then on August 19th @4:00 I had a seziour than again @5:30 I had another seziour I've never had them before the vaccine. Was hospitalized in October for 5 day's and hooked up to EEG machine to watch and see if they could see seziour like activities to the Clinic.
Myalgia, Pain and redness at site, fatigue, chills for 5 days  Narrative:
Pt complaint of numbness and tingling to upper lip area 30minutes after vaccine given. Pt did complete 15+ minutes of observation in the waiting area at the vaccine site. Pt did go to her car then came back into the vaccine site to report her symptoms. O2 @ 2L/min applied. Deep breathing encouraged. No s/s of anaphylaxis occurred. Respirations easy, skin warm and dry. Pt did present with increased anxiety prior to receiving the injection. No worsening of symptoms. Family on site to transport patient home. EMS was on site. No transport to local ER needed.
Low grade fever (99-100 degrees), flu like aches, soreness Spent 12/11/2018 in bed most the day.
Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I also felt tired and body aches. The next day I was exhausted, could hardly keep my eyes open and could not get enough water. My arm began to hurt, I had chills/fever, and my shoulders/back of my head hurt a LOT.  I also was congested, coughing and sneezing, and my chest felt tight. My knuckles and toes hurt as well. Tylenol, day-quil, aspirin, - none of these worked.  I had COVID back in June/July 2020 and the symptoms are all the same ones I had.
15 minutes after receiving the Zostavax vaccine, patient claimed that he felt tightness in his throat.
Body aches; Tired; Dizziness; Nausea; Taste metallic; It also felt tingly or spicy sensation; It also felt tingly or spicy sensation; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLOVENT), olopatadine (MANUFACTURER UNKNOWN) and fluticasone (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 19:30, three hours after the shot, the patient experienced dizziness, nausea. The next day, on 29Mar2021, the patient was nauseated, had body aches and was tired. 1-2 days after, on an unknown date of Mar2021, the patient had a weird taste metallic in mouth and also felt tingly or spicy sensation. 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 of the events dizziness, nausea, body aches, tired, weird taste metallic in mouth and also felt tingly or spicy sensation was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected
PATIENT CALLED THE PHARMACY TO REPORT, FEVER, SORE ARM, AND BODY ACHES STARTED IN THE MORNING ON JULY 13TH, 2023
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: After administration of vaccine, patient was still seated in the waiting area. I went back and checked on him after 5mins of waiting, then came back to the pharmacy. But heard a big bang shortly after. Some how, he had fallen out of his chair and bumped his head and neck on an end camp. He seemed a little confused, when I ran over, but was awake, a little sweaty and nauseated. EMS was called. They transported him to ER to have his head checked, since he bumped it.
Myocarditis leading to pulmonary edema, respiratory distress and needing intubation. Admission to PICU for 7 days. Initial treatment with Ceftriaxone, Niburone drip. Now on Captopril and Lasix.  02/19/2008 MR received for DOS 1/22-31/2008 with D/C DX:  Acute Myocarditis.  Acute Pancreatitis.  Child presented with 2-3 day hx of fever, cough, and increased WOB. Pt had vomited x 2.  Pt developed worsening respiratory distress with tachypnea and wheezing despite albuterol nebs and Prelone. Upon arrival in ED pt had an O2 sat of 70% on RA and significant retractions. Breath sounds were diminished on the R with bilateral rales. Pt was intubated due to worsening status. Admitted for ? status asthamticus with respiratory failure.  Cardiac consult with DX of myocarditis and later pancreatitis.  Feeding tube inserted. TXd with Milrinone with improvement in LV fxn and Actigall for gallbladder sludge.  Amylase and lipase had stablized by d/c. Stable or RA following extubation.
Information has been received from a physician concerning a 25 year old female with asthma and pollen allergy who on 13-JUN-2007 was vaccinated IM in the upper outer quadrant of the right buttocks, with a first dose of Gardasil (lot # 657736/0389U). Concomitant therapy included YAZ. On approximately 13-JUN-2007 the patient experienced pain at injection. On approximately 18-JUN-2007, the patient recovered from pain at injection site. On 28-JUN-2007 the patient experienced pain at injection site again with muscle twitching, stiff neck and "flu-like" symptoms. Unspecified medical attention was sought. At the time of the report the patient was recovering from pain at injection site, muscle twitching, stiff neck and "flu-like" symptoms. Unspecified medical attention was sought. The physician noted that the patient was a runner. At the time of this report the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 01/14/2007.
prolonged site soreness; swelling of lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, She does not know the date of her first, second, or booster dose and does not have lot, ndc, or expiration date to provide for the doses), for COVID-19 immunization; Bnt162b2 (second dose, She does not know the date of her first, second, or booster dose and does not have lot, ndc, or expiration date to provide for the doses), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Sep2021, outcome "unknown", described as "prolonged site soreness"; LYMPHADENOPATHY (non-serious) with onset 27Sep2021, outcome "unknown", described as "swelling of lymph nodes". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy.  Follow-up (12Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MOC called on 1/15/08 at 11 am, states child's left arm red and swollen post vaccine. Was advised to go to PMD. On 1/19/08, called MOC, states took child to hospital. Was given MOTRIN on 1/19/08 MOC states swelling went down on left arm. Was told ok to get future vaccines by MD.
Area on Left arm muscle. A crusty film appears every few months and itches and falls off. Then it keeps happening. The spot of the vaccine has a stinging feeling almost all the time. It's a discomfort and now I'm afraid to get this year flu vaccine.
Since my sons second shot was administered at the clinic I listed here, he has developed a SEVERE tic.  His head will spasm from side to side and occasionally so will his arms.
Emergency room visit with symptoms of Transient ischemic attack, high blood pressure, abnormal ECG.  Reporting this now with the announcement of Guillain Barre syndrome related to Janssen Vaccine.
Patient experienced mild erythema, swelling, and heat to the injection site.  Symptoms began several days after the injection.  Area appears to resemble a localized reaction.  Patient was started on antihistamine and antibiotic.  Patient monitored as an outpatient.
Pt received the wrong brand. Instead of Pfizer per age approval, pt received Moderna 1dose. No adverse reactions were notified.
Rash about 4 inches wide around the injection site. It is hard and hot to the touch. The rash is very itchy.
I noticed Sunday morning, December 26, 2021 the injection site on my upper left arm became red, raised and sore. Below the injection site, there were two other red, raised areas.  These two areas were not sore. Also, my left axillary had a very noticeable lump that was 3" in diameter. When I retired at 11 pm on Sunday, December 26, 2021, all the aforementioned conditions were the same.
forgot to get 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in in march 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The case was reported by the patient. He did not know exact date or location site of injections of Shingrix.  He stated that he moved and forgot to get dose 2 of Shingrix.  Medical information phone number and medical disclaimer provided.  Referred to healthcare professional. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023019049, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023019049:Same reporter.
The next morning I woke up feeling tired and I had sore muscles. I had fever in and out the next few days. The headaches started the next day around 4-5 pm and the headaches got worse. The headaches were sharp and they moved 180 degrees from the left to the right and they got so bad I had to seek a doctor. That was in the beginning and now they are dull headaches.
Extreme soreness, swelling, redness, and hot.  This was a little lower than where the vaccine was administered.  It has been 3 weeks since vaccine administered, and soreness is still present.  Redness and heat has gone away.
labeling error; 30 people received a dose after the 30 day expiry; The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021), PRODUCT LABEL ISSUE (labeling error) and EXPIRED PRODUCT ADMINISTERED (30 people received a dose after the 30 day expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and EXPIRED PRODUCT ADMINISTERED (30 people received a dose after the 30 day expiry). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (labeling error). On 30-May-2021, PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and EXPIRED PRODUCT ADMINISTERED (30 people received a dose after the 30 day expiry) had resolved. At the time of the report, PRODUCT LABEL ISSUE (labeling error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  On 26 Apr 2021, the reporter received a shipment of the Moderna COVID-19 Vaccine. The vials were kept in the fridge and a daily log of the temperature was carried out. The vials were kept between the recommended 2-8C. The last day to use the vials was 26 May 2021 however there was a labeling error and the expiry date on the vial was written as the 30 May 2021. On 30 May 2021, 30 people received the expired vaccine. 2-3 people received the vaccine as their  1st dose and the others received the vaccine as a 2nd dose.   It was reported that no patients that received the vaccine beyond the 30 day expiry, have called to report side effects.  No Treatment medication was provided.
Local inflammatino - erythema, induration, heat, no pain. Left deltoid injection approx 4.5 cm x 14 cm lateral upper left arm.
Patient came in feeling weak, tired, cough, slight fever; Tested positive for C19 on 12/05/2021; Inpatient Vitamin C; multivitamins with minerals; Zinc sulfate, Tylenol
GIVEN ON 2/2/2021 - ON 2/3/2021 MISSED WORK. EXTERMELY TIRED, CHILLS ALL DAY, BODY/JOINT SORENESS.   SLEPT ALL DAY UNTIL 5:15 PM.  THEN NO MORE CHILLS, BODY ACE STOPPED (I TOOK IBPROPHRIN -800MG) JUST TIRED . ON THRUSDAY 2/4/2021 I FEEL NORMAL.
pt admitted to hospital with SOB; positive for COVID; COVID pneumonia; given ABX, remdesivir, O2 supplementation, steroids, antioxidant vitamins; pt's condition worsened; acute kidney failure; severe hyperkalemia; pt showed no improvement; suffered a PEA arrest and passed away in the hospital
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored ROTATEQ (lot # L037921, expiry date: 31-MAY-2017). Medical assistant reported that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effects were reported. This is one five reports received from the same reported. Additional information has been requested.
A bit sore in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Aug2021, outcome "unknown", described as "A bit sore in her arm".   Follow-up (27Sep2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.