chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Partial dose of vaccine (less than 1/2 dose) was given in error and repeat dose has been rescheduled per CDC Guidelines. No adverse reaction per patient. She will return for her revaccination on 02-19-2021.
Still has pain; Had shingles despite getting 2 doses of SHINGRIX/ Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On 20th September 2018, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure and shingles were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received 2 doses Shingrix vaccine about 3 years ago and had shingles despite getting 2 doses of Shingrix and pain. The vaccine was administered into the muscle in the right deltoid. The patient shingles were disappeared, however, she still has pain from shingles. The patient does not have lot number/expiry date, dose of Shingrix, date of administration, and how soon after the vaccination did the shingles occur. The reporter gave a consent to follow-up with health care practitioner however,  does not have the name of the facility, full mailing address, fax number and an email address to health care practitioner. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles were unknown.
Mother called 3-22-07 stated arm was swollen and tender at injection site. No complaint of fever, malaise, rash. Instructed to monitor and call 3/26 if no improvement. Child came to clinic. Left arm swelling noted in lower deltoid arm. Complained of tenderness with pressure. No heat or erythema noted.
Patient reports redness around the injection site about 2 inches. Pinkness extending beyond the redness, greater than 2 inches. Warmth and pain at the injection site.
Minor swelling + tenderness at injection site. 4 days after Typhim developed soreness in arm, tenderness (no swelling) in axilla, Tingling in L fingers began 6 days after injection temp 99.8 highest red blotches on L arm.
Shortness of breath and difficulty breathing - Epi, Benedryl, and Steroids given
tingling on the left side of my spine; pulsatile tinnitus very, very loud; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER -BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm right (Lot number: EN6201) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right), administration date: 02Apr2021, for COVID-19 Immunization, reaction(s): "Pulsatile tinnitus". The following information was reported: SPINAL PAIN (disability), outcome "not recovered", described as "tingling on the left side of my spine"; TINNITUS (disability), outcome "not recovered", described as "pulsatile tinnitus very, very loud"; VISION BLURRED (disability), outcome "not recovered", described as "blurry vision". The events "tingling on the left side of my spine", "pulsatile tinnitus very, very loud" and "blurry vision" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of spinal pain, tinnitus, vision blurred.  No follow-up attempts are possible. No further information is expected.
4MAY94 morning p/immunized pt was limp, pale, clammy, c/o nausea, had 1 loose stool, c/o h/a; pt was seen by MD recommended; rest, observe, advil, po liquids;
This spontaneous report was received from a nurse via company representative, concerning an adult female patient of unknown age. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 30-JUL-2018, the patient was vaccinated with VARIVAX injection (strength, dose, route, frequency, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
A 16 year old patient and mother came in for Covid boosters. Both originally received Pfizer but they requested to switch to Moderna. My technician checked them in and provided the pharmacist with the paperwork. After verifying the dates were over 6 months the pharmacist gave the Moderna vaccine later to find out that she was only 16 and should have gotten Pfizer as booster. The parents were contacted to explain what happened and if/when to report side effects or seek medical attention.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 14-APR-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # J015063, expiry date 24-OCT-2015; exact dose was not reported). There were no concomitant therapies reported. The reporter stated that the dose of ROTATEQ administered to the patient did not have any previous temperature excursion. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Patient stated that she experienced pain in her right arm after receiving the hepatitis vaccine and the pain continued for 2 months. She was advised to talk to her doctor because it is not normal to have pain for that long after a vaccination.
Also received at pharmacy:Covid 6/11/2021 Pfizer Lot# EW0187 Left arm injections/second dose. After or between these two vaccinations I took a B12 shot in my leg and I felt it all the way up my leg into my arm where i got the vaccines and it made my arm sore and swollen and hot to the touch and it was incredibly painful. I started dreading the B12 shot after that and it happens every time i have to take a B12 shot. It hurts less than the first few times but is still significant.  Also, metal items stick to or try to stick to my vaccine injection shots area. I learned this 9/12/2023. I waved metal around my arm and it caused my arm to hurt and burn up into my neck.
suffering from early satiety with no other symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021 and was forwarded to Moderna on 27-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL DISTENSION (suffering from early satiety with no other symptoms) 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISTENSION (suffering from early satiety with no other symptoms). At the time of the report, ABDOMINAL DISTENSION (suffering from early satiety with no other symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and it contains no new information.
This spontaneous report was received from a quality control individual control individual at a medical facility refers to a patient of unknown age. On 01-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0644AE, exp: 27-MAR-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Patient called and stated that they started developing what they described as spots/rash on different parts of their body. Stated that they rash was itchy, but not painful. They said they noticed the rash 3/30/2021, the day after their vaccination. This was reported to us over the phone, so was not able to see the rash in person. It was difficult to tell based on the description if it was related to the vaccine or not. Asked the patient if they were having any other issues/symptoms related to the vaccine. The patient stated other than a sore arm no. The patient was instructed that benadryl could be used to help with the itching, and that it was important that got in to a doctor as soon as possible to get the rash looked at.
SICKNESS; SPOTS ON LEGS,CHEST, AND ASS (NEW SPOTS SHOWING UP EVERY DAY); THREW UP; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The patient experienced sick for 3 months and spots all over body and back, spots started at the injection site (Dose number in series 1). The patient had recovered from sick for 3 months, and the outcome of spots all over body and pack, spots started at the injection site was not reported.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was sick again for 3 months with spots on legs, chest, and ass. Patient states that he is sick forever and new spots are showing up every day. Patient also states that poison was put in his arm. He was sick, and states his life was ruined. (Dose number in series 2) On 04-JAN-2023, on the day of reporting, the patient just threw up in morning (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness, and spots on legs, chest, and ass (new spots showing up every day), and the outcome of threw up was not reported. This report was non-serious. This case, involving the same patient is linked to 20230108455. This case, from the same reporter is linked to 20230108457.
At about 3:22 pm, patient complained of feeling light headed. Requested to raise her lower limbs, which another chair was provided and was able to do so. Water was offered but refused. Vital signs were taken. Monitored until symptoms resolved.
Headache, severe malaise and fatigue, bradycardia, weakness. No treatment. Symptoms lasted 2 months
pt reports nausea, weakness, tingling of bilat fingertips, cold sensation fingers & nipples, h/a, temp up to 100.2 @ 230PM, T97.6, pulse 100, Bp 106/68 physical findings WNL
no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 07-MAY-2019, the patient was administered an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (Lot: R013515; expiry date: 30-MAY-2019) (dose and route of administration were not reported). The vaccine was exposed to 11.3 C for 1 hour and 40 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported.  This is one of the two cases received from the same reporter.
expired dose of ActHib was administered, no AE; a 12 months old patient received a first dose of ActHib vaccine, no AE; expired dose of ActHib was administered at right gluteus, no AE; Initial information received on 06-Jul-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 12 months old male patient who was vaccinated with a 0.5 mL expired dose (first dose) of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ112AAC and expiry date 06-Jul-2020) via intramuscular route in the right gluteus medius on 06-Jul-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for prophylactic vaccination.  It is an actual medication error case due to expired vaccine used, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site. It was reported that an expired first dose of ActHib was administered to a 12 months old patient.  At the time of this 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 holder's compliance with the requirements set out in Directive and Module VI of the 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.
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     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 CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death and medically significant). The reported cause of death was complication of stroke. An autopsy was not performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Company comment: This spontaneous case concerns a 26-year-old male patient, with no medical history reported, who experienced the unexpected and serious (death and medically significant) AESI of CEREBROVASCULAR ACCIDENT and died. The vaccination date with an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine was not reported; hence, latency could not be properly assessed. The reported cause of death was complication of a stroke. It is unknown if an autopsy was performed. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-750562, US-MODERNATX, INC.-MOD-2023-750508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750562:Same Reporter Different Patient US-MODERNATX, INC.-MOD-2023-750508:Same Reporter Different Patient; Reported Cause(s) of Death: complication of stroke
Tachycardia; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 21Dec2020 12:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient experienced tachycardia on 22Dec2020 02:30. No treatment received for the event. The outcome of the event was not recovered.  The following information on the batch number has been requested.
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness.  Attempted to sleep after taking Advil with nightmares and restlessness.   Felt this overall feeling of crying and uncontrolled sobbing.   I had COVID in May of 2020 with hospitalization,  Remdesivir IV.  Pneumonia .  July I was feeling better with noted Shortness of Breath not brought on by activity.   I was able to resume my exercise activity.  I walked but no longer able to walk 3-4 miles per day.   I am walking 2 miles w  strengthening exercise.   The headache comes and goes with the addition of Advil and Tylenol  alternating takes the edge off.   I take a Zyrtec but it does not help
Vaccinated 2/03/15 - pt was cranky and then rash appeared 2/13/15. Rash (B) legs (+) itching. No real zoster rash but raised and red. BENADRYL and oatmeal bath.
Hospital Course: 64 y old female patient, severely cachectic, deconditioned with nonischemic CM, LVEF 20-25%, chronic Afib, s/p BIV ICD, Prior DVT, PEs, severe MR/TR, moderate PH, Hypothyroidism, prior Stroke, CKD stage IV, high grade renal artery stenosis, chronic hypoxia, on supplemental O2, recently admitted with hemorrhagic shock, acute blood loss anemia, large right rectus sheath Hematoma, s/p coli embolization of inferior epigastric artery on 11/14 who presented on 11/29 with progressive dyspnea, multiple loose tool and acute confusion. CT chest and abdomen revealed stable size of rectus sheath hematoma, revealed right sided pleural effusion and bibasilar air space disease. SARS COV2 screen was positive. Patient was hypotensive. Improved with IV fluids and dobutamine. She was admitted with hypovolemia, severe sepsis, viral sepsis, SARS COV2 pneumonia. Initially to mod care. She was started on antimicrobial  coverage concerning super imposed bacterial pneumonia.  Patient was transferred to ICU on 12/03 after she became less responsive with progressive hypoxia, lactic acidosis.  Patient was intubated due to progressive hypoxia, worsening hemodynamic status, not tolerating BIPAP and increases in work of breathing. Intubated with RSI first attempt. Dobutamine is decreased to 2.5 mcg/kg/min. Continue Norepinephrine. Add Vasopressin given tachyarrhythmia.  Patient continues to progressively worsen hemodynamically with increase in pressor requirements, oliguria, worsening lactic acidosis. Received multiple boluses of IV fluids. Remained on broad spectrum Abx. Patient developed refractory shock with multiorgan failure ,Progressive metabolic acidosis, renal failure, known advance heart failure with severe systolic heart failure.  On maximal dose epinephrine, Norepinephrine, dobutamine and Vasopressin.   12/07: patient remained in very critical condition. On mechanical ventilation support. ABG showed PH 7.12, Pao2 of 282, Paco2 of 24. Extremely elevated D dimer of > 90 K. Patient is not on sedation. Unresponsive. Right pupil > left. Significant lactic acidosis, significant elevation in AST/ALT. Shock Liver status. INR 3.9. progressive renal failure. Oliguric. High vasoactive support demands with Norepinephrine, epinephrine, vasopressin and dobutamine. To initiate PIRRT.  Patient remained in refractory shock with multisystem failure. Did not tolerate PIRRT due to hypotension despite of maximal vasoactive support.  She expired despite numerous CPR rounds.
Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breast feeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Seen on 7/7/00, 10cm X 8.5cm area of erythema, urticaria at injection site. Local reaction treated with Benadryl.
I woke up with my Rt ear feeling like it was clogged and needed to be popped. It lasts between 1-1.5 hours after awaking every morning since my injectiion on 03/25/2021.  Occasionally it becomes hard to hear out of my Rt ear.
Right thumb went numb and tingled.  Left thumb and index finger has sensation of pins and needles feeling.  Tiredness...
experienced some arm soreness like all the previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced some arm soreness like all the previous doses". Additional information she received the second booster dose Pfizer BioNTech Covid vaccine on Monday afternoon around 215 and experienced some arm soreness like all the previous doses. However, she has also been experiencing other side effects such as excessive thirst, diarrhea and lost of appetite (she did not have these side effects with previous doses). Stated that she is not sure that some of the side effects of getting diarrhea. Stated that she did not get this before and wanted to know how long does it last. Wanted to know if this is a normal side effect, how long it lasts and how to treat it. Stated that she had major loss of appetite. Stated that she had the vaccine at 2:15 on Monday and had no side effects until last night. Stated that she had all other Pfizer vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.