chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A minute or so after receiving the shot, I felt dizzy and my vision started to blacken. I informed the nurse who had me lay down and gave me a cup of water. After drinking the water the dizziness and blackness faded and I was fine 5-10ish minutes later. The next morning, my arm was swollen and red around where the shot was and it is painful to touch.
Seconds after shot was administered there was a stabbing sensation, not from the needle prick, at the injection site. A couple of minutes later, blood pressure drastically dropped, lost color in the face, weakness, dizziness. Felt much better lying down with legs elevated, but couldn't sit up even in a chair. Ambulance was called and took me to the hospital emergency room for further precaution. After lying down for a couple of hours I was able to walk out of the clinic on my own. I did feel weak and a little dizzy for the following 36 hours or so.
Initial unsolicited report received from a customer via social media on 10 October 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. This case involves a patient (unknown age and gender) who was vaccinated with INFLUENZA VACCINE (Flu shot) (batch number, expiry date of product, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date and unspecified duration following the vaccination, the patient experienced flu. Lab data included and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Received Engerix-B as Her 2nd Dose; Initial Report Received on 13-Jan-2022  A pharmacist in the reported that a 29-year-old female patient (race and ethnicity unknown) received Engerix-B as her second dose.  No medical history was reported.   Concomitant medications were reported as unknown.  On 24-Nov-2021, the patient received the first dose of HEPLISAV-B (Lot # 935841, expiration date 17 Sep-2022, serial # 424027557240, and NDC # 43528-003-05) in the left deltoid.   On 13-Jan-2022, 51 days after having received the first dose of HEPLISAV-B vaccination, the patient accidently received Engerix-B as the second dose (Lot #, expiration date, and NDC # unknown) in the left deltoid.  The patient was not pregnant and there were no adverse effects reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient had symptoms of a cerebral vascular accident (CVA) on the 6th day after the 2nd dose of COVID-19 vaccine. It seemed to have resolved in 24 hours and was asymptomatic when she presented after 72 hours of the symptoms at the clinic.
Information has been received from a Nurse practitioner concerning a 19 year old female patient with no pertinent medical history and no known drug allergies who on an unspecified date was vaccinated with the first dose of GARDASIL 0.5 mL IM. On 28-DEC-2009, the patient was vaccinated with a second dose of GARDASIL 0.5 mL IM. The Nurse reported that the patient developed fever, body aches and anxiety within 8 hours of each dose. The symptoms resolved after 24 hours without requiring treatment in both instances. The patient sought unspecified medical attention. No further information is available.
Pt to ED 6/8 for generalized weakness and cough. COVID+ 6/8, pt in no apparent distress, respirations even & non labored. Pt. awake, alert and oriented x3. Pt is currently on room air, maintained on Rocephin. 6/11 pt is asymptomatic and on room air and will not qualify for treatment for COVID-19. 6/11 pt is A&OX4, she denies pain, SOB, and distress. Pt discharged.
Suspected shoulder injury related to vaccine administration, immobility due to incorrectly placed shot (too high/deep on shoulder); couldn't move for 3 days without intense pain; Suspected shoulder injury related to vaccine administration  immobility due to incorrectly placed shot (too high/deep on shoulder); couldn't move for 3 days without intense pain; Body chills followed by a fever blister developing on the bottom lip; Body chills followed by a fever blister developing on the bottom lip; Single hive on left arm and itchy scalp; Single hive on left arm and itchy scalp; This is a spontaneous report from a non-contactable consumer.   A 34-years-old non- Pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Age at vaccination 34 years), as dose 1, single for covid-19 immunization. Medical history included Mild asthma, Fibromyalgia, depression, anxiety IBS (Irritable bowel syndrome (IBS). Concomitant medications included sertraline hcl (ZOLOFT); gabapentin; levocetirizine dihydrochloride (XYZAL); ethinylestradiol, norgestimate (TRI-PREVIFEM); vitamin d3 (VITAMIN D3). The patient previously took chlorhexidine (cetrimide;chlorhexidine), Wellbutrin (Allergies to medications, food, or other products like Chlorhexidine, Wellbutrin). Most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced suspected shoulder injury related to vaccine administration, immobility due to incorrectly placed shot (too high/deep on shoulder); could not move for 3 days without intense pain; felt as if shoulder was dislocated, body chills followed by a fever blister developing on the bottom lip, single hive on left arm and itchy scalp. Patient did not receive any treatment for reported events. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Had immediate pain at site of injection and general vicinity. Pain worsened in the following days. Pain never completely resolved and still has episodes of pain and achiness to the area.
swelling, redness in immed vax area dx as local infect; area (about 3in diameter) was hard to touch & sore for 2-3 wk; gen body ache/fever/chills for first few days;
Burning sensation in the back of the head along with headaches on and off for over 3 weeks. Sore neck that irradiates to left arm and all the way to middle back on and off for 3 weeks. Flu like symptoms the day after the vaccine was received
Case previously recorded as MA2009-3673. Initial case report received from a consumer on 04 NOV 2009. A 2 year-old male patient was inadvertently vaccinated i.m with FLUVIRIN (batch no. 1009233P) on an unknown date. No adverse events were reported.
Vertigo and severe dizziness, one day after first vaccine administration. Unable to stand up without syncope. Symptoms have decreased since second dose. On 5/3/2021 Only has slight dizziness when getting up.
Severe total body Hives, lasting days, requiring multiple medications, treated with medrol, benadryl, pepcid, hydroxyzine
Patient received Pediatric Pfizer dose as patient needed to receive Pfizer 12+. No Adverse reaction occurred.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 2:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Nov-2021 at 2:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Fahrenheit. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Treatment information was not provided.
Very itchy rash all over the body. beginning 2 days after injection. Felt like flea bites. They were not. Exterminators called and treated house on 03/04/21. Rash kept getting worse, and swelling in right calf was detected.. Monday 03/07/21 went to emergency roon. Visual examination diagnosed allergic reaction to vaccine.. Began prednisone and benadryl treatment that day.. As of today, it is  better, but still some rash left and swelling id down in right calf.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a five- months old male patient who was vaccinated with a third dose of PENTACEL (lot C5447AA; expiry date: 18-Oct-2019 via intramuscular route on 13-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PREVNAR for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that only gave the liquid diluent portion of the suspect and did not mix the ACTHIB dry powder portion with it before administering the vaccine. The patient did not show any signs of any AE's at the time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
pt recv vax 28AUG96 & 21APR97 pt exp crankiness & irritability;23APR97 pt devel itchy blobs @ hairline & neck;pt was examined by MD & dx w/chickenpox;30MAY97 pt recovered;
Patient presented to the Pharmacy on 09/02/2022 with a prescription for Cephalexin 500mg cap and referred that she went to a Clinic to receive service due to swollen arm after vaccination. Upon verification of her record, I noticed that the patient had already received this vaccine back in 03/06/2022. She was counseled about the duplicity.
10/25/2022:  11:58 AM:  Flu shot administered in right shoulder, too high, had sharp pain.  9:00PM  Extreme pain in Rt. shoulder and upper arm, could not sleep. 11/01/2022:  Saw Dr.; started on steroid pack and Ibuprofen 800 Mg 3 x day.  Steroid did not help 11/11/2022;  Went back to Dr.:  Had x-ray taken, wanted an MRI scheduled.  Felt since this needed an MRI, I made appt with Dr., orthopedist.  Dr. put me on light duty at work.  No lifting of any kind rt. arm 11/16/2022;  saw Dr.,  did another x-ray and scheduled MRI for next Monday.  Gave me a prescription for the pain, dilaudid 2 mg. 1 tab at night to help me sleep. 11/21/2022:  MRI done. 11/23/2022; To Dr., saw, his PA.  Said there is a slight tear in the rotator cuff and severe myoedema. 11/29/2022; Saw Dr.; discussed the MRI, the severe myoedema and tears in muscle.  Gave me a steroid shot.  Placed on light duty with no lifting rt. arm for 6 wks.  Told me to take ibuprofen800 mg 3x a day. 12/14/2022; steroid shot has worn off, more pain with active movement.  Unable to raise arm to the side. 01/10/2023; Went back to Dr.; did not want to try another steroide shot; wants me to remain on light duty with weight restriction of less than 5 lbs. 01/29/2023;  Off and on intense pain in right arm, unable to lift right arm past 85-90 degrees. 02/10/2023; still having pain with movement and still taking Ibuprofen 3x a day
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. On 27-Oct-2021, Excursion time was 10 AM, temp was 32 , total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021, 4 vial was moved to clinic. Vaccine BUD date was 04-Nov-2021. On 27-Oct-2021, Excursion time was 9 AM, temp was 29 , total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021, 2 vial was moved to clinic. Vaccine BUD date was 29-Oct-2021. Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration at 8 AM:41,  9 AM:29, 10 AM: 32, 11 AM:43, 12 AM:43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vials only punctured right before administration  Treatment medications were not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0158), in right arm, on 27Apr2021 as dose 2, single (Lot number: EW0169), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cleft palette" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies: Sulfamethoxazole"; Ciprofloxacin, reaction(s): "known allergies: ciprofloxacin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19".  Therapeutic measures were taken as a result of vaccination failure, covid-19. Investigation result received on 05Nov2022. The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine Injectable lot EW0158, EW0169 and FF2587 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0158, fill lot EP8693, bulk formulated drug product lot EW8072; lot EW0169, fill lot EP8700, and the bulk formulated drug product EP8602; lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DRY MOUTH (dry mouth) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced DRY MOUTH (dry mouth). At the time of the report, DRY MOUTH (dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient was pregnant.  The patient complained of a dry mouth after the first dose in their primary series.  No treatment details were reported.
Fever spiking to 104, redness at injection site, hardness at injection site, pain causing wincing and crying, toddler not using arm when at all possible.
Information has been received from a physician concerning a 20 year old female who on 15-JAN-2008 was vaccinated intramuscularly with the first dose of Gardasil (655327/1287U).  On 25-JAN-2008 the patient experienced a generalized rash.  The patient went to the physician's office on 28-JAN-2008 and was told to take diphenhydramine hydrochloride (BENADRYL).  Subsequently, the patient recovered from the generalized rash.  No further information was provided.  Additional information has been requested.
toothache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced toothache on an unspecified date.  Therapeutic measures included paracetamol (TYLENOL). The outcome of event was unknown.  Information on Lot/Batch has been requested.
Pt. received on injection 12/28/20. They are experiencing a delayed reaction at the injection site. On Sunday 1/3, pt. had slight itching at the site. 1/4, the itching was worse & pt had some warmth/redness/swelling at the site (approx 3 cm in diameter) . Pt took 25 mg benadryl & 800 mg motrin when they got home from work at about 2 am on 1/5. Pt also used OTC hydrocortisone w/no relief. The site remains very itchy & warm to touch. There is slight redness & the area is now about 4-5 cm in diameter.
About 10 minutes after administered vaccine, patient felt a little dizzy and wasn't able to stand up. She eventually felt very nauseated, threw up in the office, but felt almost immediately better after she vomited.
Swelling left non-dominant arm persistent 6 months after vaccination. Objective measurements up to 4.5 cm larger than dominant arm
On Jan 26 04 at 0920 pt was given influenza vaccine 0.5CC ID in L. arm at approx. 0925 pt fainted and hit her head on the exam table. At 0929 pt was give O2 via mask at 10L/min and EPI-PCN JP 0.15mg.0/3Ml, right thigh. Pt complained of lump in throat.
HISTORY OF PRESENT ILLNESS: Patient is a 41 year old male who is being admitted for chief complaint of shortness of breath and chest pain. Patient has been having ongoing symptoms for the past 2 weeks. Recently he developed peripheral edema, preceeded by a viral illness (unsure if COVID-19). Patient was seen in the clinic yesterday, EKG was done and noted tachycardia with heart rate of 107. Echocardiogram performed in the ED showed severe LV dysfunction with EF of 20-25%, concern for new onset cardiomyopathy.   Patient has received both doses of the COVID-19 vaccine.
1.3 ml of diluent added to 6 mo-4 yr multidose vial. Should have been 2.2 ml added. Parent notified by Dr. later that day.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with improperly stored doses of GARDASIL (lot# K010215 with expiration date 05-MAY-2017; lot# was reported as "L030864" with 07-JUL-2018, strength, dose and route were unknown). The patient's concomitant medications was not reported. No adverse effects have been reported. Additional information has been requested.