chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had vaccination on 09/15/2022. On 02/19/2023 I became sick with sinus infection. I was COVID 19 negative. Over the counter medication was not working. I went to urgent care and was prescribed a med pack. The medication helped and I felt better in 3 to 4 days.
3 days high fever, large circumference erythema & tenderness around injection site, additional 3 days fatigue & slight dyspnea.
3 days post vaccination patient reported soreness at the vaccine site with mild erythema, headache and knee pain
Left ant. thigh knot persistent x 8 days. Slight red x 2 days. No temp, no pain.
Approximately 18 hours after receiving immunizations, patient reported to ER with 104.4'F temp. Tylenol & Motrin was given. Temp decreased and patient was discharged.
While giving injection, nurse stated the plunger was difficult to push after giving 0.1 mL so she pulled it out, pulled and pushed the plunger a few times, wiped off the needle with an alcohol swab and reinjected the needle into the patient's arm to the remaining 0.2 mL.  However, some fluid ran down the patient's arm so it is impossible to know how much the patient received.  With most vaccines, partial or incomplete doses are considered invalid and the recommendation is to repeat the full dose; however less data/experience with COVID vaccines.  Also generally not advised to reindroduce the same needle twice to finish an incomplete injection. Patient only wanted to receive the 0.2 mL partial dose, this was administered as a 3rd injection on the same date.
38yr old patient was administered influenza IIV4, IM (FLULAVAL QUAD 2022-2023 (PF), LOT # CA52L) IM in right deltoid on 10/28/22 during office visit.  Later on 11/22 patient called office stating that shot had been administered too high on arm which immediately caused pain.  CMA was not notified of pain.  Patient later presented at ER on 11/8 and was diagnosed with shoulder bursitis.  Patient endorsed having numbness in right arm, difficulty lifting arm and using right hand, however, denied redness, warmth or swelling.  Patient had been taking ibuprofen for pain. ER prescribed methylprednisolone dosepack.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 70 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "post breast cancer" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive other medication in 2 weeks.
Light headache; Feel tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EN6201) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Light headache"; FATIGUE (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Feel tired". Therapeutic measures were not taken as a result of headache, fatigue.  Additional Information: Patient reported that the tiredness and headache began Saturday 27Mar2021, for which he has done no treatment. Since then, patient said it has gotten worse. He would like to know if there was anything he could take or do to relieve his side effect symptoms.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
a four years old female patient was given Flublok quadrivalent influenza vaccine/No AE; 4 year old patient received vaccine in thigh; Initial information received on 10-Oct-2019 and additional information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/ non health care professional (office staff).  This case is linked to case 2019SA284719 (same reporter).  This case involves a four years old female patient who was inadvertently given a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1929, expiry date: 30-Jun-2020 via intramuscular route in the right thigh on 08-Oct-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and Vaccine administered at inappropriate site .  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Within an hour of injection, patient began to experience soreness and swelling near injection site. She said it felt "tight". She said it had not gone to her hand. RPh instructed her to use ice and take ibuprofen and take BENADRYL if worsened and call MD if worse right arm. Tried to call had to leave message-patient never called back.
MMR administered in R thigh-area size of golf ball hot to touch-red-itching-noticed on 8/28/03. Given Lidex cream bid-Benadryll prn Zyrtec 1 tspod.
Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported   No treatment medication was reported
A mouth or so later  told kids thought it affected my brain.   was mixed up In April started noticing Tremors
w/in 12hr of vax pt devel an inj site rxn characterized by tenderness & a 2inch by 2inch welt;pt was improving as of 29OCT;this is 1 of 5 pt out of 12 vaccinees to exp this event;
Pt pulmonary problems needed oxygen hospitalization. Pt eczema itching ,swelling, severe skin problems. Pt eventually developed asthma.
C. difficile colitis - She was given 2 liters of IV normal saline and her blood pressures improved. She was given 4 mg IV Zofran, which resolved her nausea and dry heaving.  She was admitted to inpatient for C. difficile colitis. She was started on IV metronidazole 500 mg 200 mL/hr Q8H, IV famotidine, and oral vancomycin 500 mg. She will be discharged on 125 mg oral vancomycin QID and 4 mg oral Zofran PRN, and was encouraged to push fluids. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Pain in right arm started Monday 10/17/11 evening at 7 or 8 PM had trouble sleeping. Tuesday 10/18/11 still moderate pain - could not sleep at all Wednesday 10/19/11 - severe pain arm, shoulder, neck.
Information has been received via the Pregnancy registry, from a registered nurse, concerning a 26 year old female patient with tobacco use, no known allergies, and a history of cervical dysplasia, who on 04-MAY-2007 was vaccinated with the first dose of Gardasil (lot #657868/0523U). Concomitant therapy included alprazolam (XANAX) (reported as not used since therapy with Gardasil). On approximately 19-JUN-2007 the patient had her LMP, and subsequently became pregnant. On 10-JUL-2007, she was vaccinated with the second dose of Gardasil (lot # not provided). On 21-NOV-2007, the patient called the physician's office to inform them that she was pregnant and being followed another physician (details not provided). The nurse added that the patient was recently hospitalized (date not specified) for a cervical cerclage procedure, and remained on bedrest. The estimated date of delivery was 27-MAR-2008. At the time of this report, the outcome of the event was unknown. The nurse stated that the physician who was following the patient, felt that cervical cerclage was not related to therapy with Gardasil. The reporter considered cervical cerclage to be serious as disabling/incapacitating. Additional information has been requested.
Severe pain in the arm; Tingling in fingers; Numbness in fingers; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, tingling of extremity and numbness in fingers. On an unknown date, the outcome of the pain in arm, tingling of extremity and numbness in fingers were unknown.   It was unknown if the reporter considered the pain in arm, tingling of extremity and numbness in fingers to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-APR-2022  Reporter's Comments: This case was reported by pharmacist for herself. The patient received 1st dose of Shingrix in right arm and had severe pain in the arm, tingling and numbness in fingers of arm used for injection. The reporter consented to follow up.
The online form showed the child had two Covid Vaccines; the online form did NOT show the child had already received the Bivalent Covid vaccine a month earlier; the parent did not have the child's Covid Vaccine card so Nurse administered Covid Bivalent vaccine. An hour later when entering the Covid vaccine into the electronic medical record, the Nurse saw the child had already received the Covid Bivalent vaccine a month error, meaning vaccine administered today was a medical error.
I woke up Thursday morning and I didn't feel well. I felt achy and had a headache and felt a little bit nauseous. My husband brought me TYLENOL and I took 3 of those. I laid in bed all morning progressively getting worse. Around 12PM, I started vomiting every hour on the hour. After 15 minutes of vomiting, I felt the need to vomit again. My husband called the clinic to get me an IV, but they did not have an available appointment until the next morning at 10AM. I continued to vomit until 7:30PM. I took clonazepam, went to bed, and woke up the next morning and I was still nauseous and had diarrhea as well. I also felt like I couldn't breathe. It felt like someone was sitting on my chest and I just couldn't catch my breath. I also had really bad lower back pain. I went to the clinic and I let them know about all of the symptoms. They gave me an anti-inflammatory in the IV as well as vitamins and PHENERGAN. I was there for about an hour and I didn't feel that great. I continued to have a headache that day and even this morning. I still have a slight headache. I never had these symptoms with the 3 Pfizer vaccines I took previously before this vaccine.
in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.
Local reaction at injection site - swelling/tenderness/redness. Myalgias and fever to 101 degrees F - lasted approximately 48 hrs. Local reaction improved in 5-7 days.
2-3 lymph nodes swelled to size of grapes. They were very tender to touch 8-9/10 pain scale. Fever 101 degrees, aches from head to toe, even teeth hurt, sore throat. Patient had exacerbation same symptoms which patient had Tdap vaccination.
Patient passed out about 3 minutes after receiving the vaccine. Patient was seated and rolled forward then his whole body stiffened backwards.  The eyes rolled back then he started to slowly come to.
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection.  About 79 hours after injection, noticed petechiae on  bilateral lower legs only . . Notified my PCP the next day.  No nosebleed on day 4 after injection and petechiae  stable - maybe spread a little but still below the knees.    ( Had previous COVID-19  infection that symptoms started  around  11/29/2020)
felt similar like she was one step behind in her brain or in thinking; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller reported that yesterday his wife's friend's daughter got the shot and felt similar like she was one step behind in her brain or in thinking on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
DEVELOPED FEVER, HEADACHE, NAUSEA, VOMITING 5/13/2009 AT NIGHT.  LAB TESTS NEGATIVE-REFERRED TO HOSPITAL 12/30/09  DC Summary, ED  and Hospital records received for DOS 05/14/09-05/16/09  Pt. presented with one-day history of headache, fever,vomiting, photophobia. Pt. admitted for rehydration, antibiotics. Discharged stable. DC DX: viral meningitis; headache, resolved; dehydration, resolved
65 year old female received DECAVAC and TYPHM VI in right deltoid on 8/4/08. Complains of persistent soreness and "lump" in arm after vaccine. Exam-two small nodules at injection site palpable with deep pressure, possible scar tissue formation. No muscle atrophy. Mild weakness compared to left arm. No worsening symptoms per patient.
Child rcv'd Menveo in RD on 06-25-20 & HPV in LD..mom states that on 06-26-20-dad noticed RD swollen, Red, warm to touch called PCP to get an appt for allergic RXN to Menveo. In office child was noted to have a 10cm x 8cm RXN. Continue cool compresses & Benadryl--no abx prescribed. F/u as needed.
A non - serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events reported through the medical clinic associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.
received an ActHIB vaccine, but it was later discovered that the diluent of that vaccine had already expired with no adverse event; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to case 2020SA263869.  This case involves a 12 months old male patient who received a 0.5 ml once fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB], single dose vial (lot: UJ114AAA, expiry date: 24-Aug-2020, vaccination site not reported), via Intramuscular route, on 02-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13)  It was an actual medication error due to the expired product administered. It was reported that a patient received an Act HIB vaccine, but it was later discovered that the diluent of that vaccine had already expired. (latency- on the same day)  At the time of reporting, the patient had no adverse event.  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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives within 24 hours of receiving the shots; hives clustered together in large mass all over body within 72 hours post injection
multiple transient ischemic attack; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation and refers to a 74 years old  male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 20-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for prophylaxis. As a result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer multiple transient ischaemic attack with the first took place on 24-SEP-2017, including any and all of their sequelae. As a result, the patient suffered from severe personal injuries, pain and emotional distress, as well as to incur substancial economic damages.    The outcome of transient ischaemic attack was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of transient ischaemic attack was considered to be medically significant.  .
pt states that her right arm hurt and was very sore for about 3 or 4 days.  It started itching and burning around the injection site.  She became very fatigued.  She took Benadryl for her symptoms which seems to help.
pt recvd vax & 7 to 10 days p/vax woke up tired in the morning, exp joint pain & swelling, could not close hands & could hardly walk;5JUN95, presented to MD;blood tests ordered;pt dx'd w/acute allerg rxn to vax which affected nervous system
9APR99 pt broke out w/varicella rash first to back w/several large blisters then legs, scalp & face including eyelid;more than 100 vesicles responded 12APR99;itching & pain;
Fever, headache, chills, sweats, nausea, tachycardia, sensitivity to light, muscle soreness and weakness
Armpit lymph node/gland pain on the same arm as the injection  for three days slowly subsiding
after receiving vaccine patient felt dizzy, nauseated and threw up. after she threw up she felt better. Pharmacy monito red  patient for another 30 min. Before she left she was ok.
High Fever 102 Severe Headache Malaise / brain fog Chill Body Ache Exhaustion Swollen and tender lymph nodes in neck on left side Symptoms lasted for 3 days Today is day  4 and I still have Malaise, swollen lymph nodes and pressure in my head.
Moderna Vaccine booster dose (0.25ml) administered with published expiration date 10/15/2021. Patient observed 15min after injection.  No complications noted.
Suspected vaccination failure; got shingles; This serious 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient received the vaccine and 2 years later got the shingles. Follow-up was not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.