chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adacel syringe described as having a cracked hub allowing the vaccine to leak from the hub and not flow into the syringe; The nurse reported that the leak was noted while injecting into a patient; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient  (unknown demography) who while injection with a dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6737AA and expiration date 09-Jul-2022) had the leak that was noted by nurse while injecting and also adacel syringe described as having a cracked hub allowing the vaccine to leak from the hub and not flow into the syringe via unknown route in unknown administration site for prophylactic vaccination on an unknown date (underdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of syringe leak (syringe issue) and vaccine underdose.  Also reported that: How purchased: Direct ;Number of units affected: 1- Adacel ; dose not used or not available: not used ; Whether product was available for return: Yes ; Leaking ; Where is it leaking from? Tip of the needle ;Diluent or vaccine leaking? Vaccine; During withdrawal from vial? NA  (not applicable) ;Sanofi Pasteur prefilled syringe or your syringe? Pasteur prefilled syringe; Was air injected into vial? NA (not applicable) ; Was there a vacuum in the vial? Yes ;Was vial punctured multiple times? not applicable;  Did the product spray out of the vial? not applicable; Any signs of damage or tampering with the vial, stopper, flip seal or carton? No ; How often was vial punctured? not applicable.  No laboratory data reported.  No information on the corrective treatment was reported.  Outcome for both the reported events were not applicable.
Well at time of vaccination.  Developed fever to 101.5 and brief tonic clonic seizure on night of vaccination.  Infant was taken to ED by EMS and had normal exam with exception of fever to 101.5.  Blood samples and urine samples were obtained and infant was given dose of rocephin due to leukocytosis.  Seizure was felt to be due to fever.  He did not require hospitalization and fully recovered prior to discharge from ED.  Follow-up exam the following day was entirely normal.  Seizure not likely true adverse event.  More likely due to fever.
Pain, numbness and burning in bilateral hips and bilateral lower extremities. Was hospitalized for five and a half days with many diagnostic tests including lumbar puncture, blood patch, CT scan of L spine with and without contrast, MRI of CSpine, TSpine and LSpine with and without contrast and lab work. Diagnosis is early acute inflammatory demyelinating polyneuropathy, Guillian-Barre Syndrome Treatment is 75 milligrams of LYRICA trice a day and possibly IVIG treatments/blood transfusions. Following up with neurology every six weeks.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004969: US-009507513-2005USA0049670: US-009507513-2005USA0049671: US-009507513-2005USA0049672: US-009507513-2005USA0049673: US-009507513-2005USA0049674: US-009507513-2005USA0049675: US-009507513-2005USA0049676: US-009507513-2005USA0049677: US-009507513-2005USA0049678: US-009507513-2005USA0049679: US-009507513-2005USA0049680: US-009507513-2005USA0049681: US-009507513-2005USA0049682: US-009507513-2005USA0049683: US-009507513-2005USA0049684: US-009507513-2005USA0049685: US-009507513-2005USA0049686: US-009507513-2005USA0049687: US-009507513-2005USA0049688: US-009507513-2005USA0049689: US-009507513-2005USA0049690: US-009507513-2005USA0049691: US-009507513-2005USA0049692: US-009507513-2005USA0049693:
My next menstrual cycle changed completely and still, 7 months later, has not gone back to normal. The change was very sudden.  My period always happened the exact same way for over 30 years. It always began in the morning with a heavy flow for one day, and slowly dissipated over the next four days.  After the second vaccine, I very lightly spot for two days, then heavy for two days, then a much longer dissipation. Nothing in my life, diet, routine, stress level had changed at the time this sudden change began. I am reporting it now because it has not gone back to normal.  I believe the change was too sudden of an onset to attribute to pre-menopause. I have no symptoms or signs of beginning menopause.
Vaccine was expired (4 days), manufacture was notified, Moderna is evaluating the effectiveness of the expired vaccine and we are waiting for a response.  Note: her first two vaccines were
Patient presented to the ER the following day with signs of malaise, joint pain, redness at injection site, nausea, vomitting, fever and chills
Red, itchy rash beginning on arm of injection then spread across chest, other arm, down legs, face and neck.
a little bit of hives on hand; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration on an unspecified date as second, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as first, single dose for COVID-19 immunization and experienced rash on legs and arm. The patient experienced a little bit of hives on hand on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021537812 same patient, different event, different dose of vaccine
headaches (very strong) irregular heart beats upper respiratory problems menstrual periods Joint pain (knee, hands, elbows) with blood clots.
It was reported from an article, published on 29-JUN-2009 that there were "hundreds" of life-threatening reactions said to be associated with GARDASIL.  This is one of several reports received from the same source.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Muscle aches and chills 1-3 days after shot,  10 days after shot COVID  arm reaction (swelling and itching)
-Chest tightness approximately 45 minutes after vaccine. -Received 0.30 ml Epinephrine 1:1000, 14:22 PM. -Symptoms improved 14:30 PM. -Seen by provider 15:15 PM. -Prednisone tapering dose prescribed.
18NOV T101, T99;rash fine, red papular rash anterior;21NOV persistent crying 3 days;no fever, no rash;
Patient began felling flush and hot.  Throat itching.  She was given 50 mg  of diphenhydramine.  She does carry an Epi-pen due to bee stings.  She did not want to take the Epi-pen initially. we watched for about 10 more minutes.  Voice was beginning to get raspy, and she reported increased feeling of swelling in vocal chords.  We took patient to the ED triage area and she administered her Epi -pen.  She was registered in the ED and was placed in a room for observation/monitoring.  She was given an additional 25 mg of IV diphenhydramine and also 125mg of Solu-Medrol.  Following this regimen, the patient began feeling much better.  She was monitored for an additional 2 hours.  I stayed with the patient while in ED and she recovered from the reaction with no additional sequalae.
The day I received the vaccine, I had the typical symptoms of sore arm and exhaustion. The next day, I slept most of the day and had an awful headache that would not go away with ibuprofen/tylenol.   Day 3 after receiving the vaccine, about an inch down from my vaccine sight I had a warm, welt looking rash about the size of a tennis ball. It is just now starting to fade and it has been 6 days since I received the vaccine.
There was no true adverse event related to the vaccine.  I had been vaccinated fully and had two boosters, the last of which was on 3/29/22.   On 4/1/22, I visited my 2 y.o. grandchild for his birthday.  The next day, his babysitter called to say that she tested positive for COVID.  Within 48 hours, my wife and I, my son and daughter-in-law, and their two children all tested positive for COVID.  I was fortunate to receive Paxlovid and am doing well.
PCR Covid test, results cam back positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (PCR Covid test, results cam back positive) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COVID-19 (PCR Covid test, results cam back positive). At the time of the report, COVID-19 (PCR Covid test, results cam back positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
I have had the taste of metal in my mouth for approx.. 4 hours since receiving the Flu Vaccine. The taste is very strong.
Swelling started 5 hours after injection in left upper arm. Increasing swelling and  redness for a next two days. Seen on October 2, 2020  in office. At time swelling and redness decreased but required steroids for 3 days. Resoled symptoms. Follow up visit on October 12, 2020.
Itching on arms and legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arms and legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching on arms and legs). At the time of the report, PRURITUS (Itching on arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   The itching was driving her nuts.
L side axilla lymph node swelling starting 36 hours after secoond Moderna vaccine. ( Also chills and joint stiffness and fatigue. ). But this report is about lymph node. ( Only remaining side effect after 48 hours).
rt thigh red, hot swollen;t101 x 24hrs;APAP given prior to shot & afterward to keep temp down;shrill cry x 5hrs w/little sleep in between;called PMD who will take pt for check up prior to next shot;mom questioned if crying from shot or gas
Patient reported being unable to breathe approximately 10 minutes after receiving the vaccine and requested epipen to be administered but then later changed her mind and wanted to wait for EMTs. Signs and symptoms mimicked those of an anxiety attack and paramedics also concluded it was an anxiety attack
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient's age at event onset was not reported but it could be 72 years or 73 years. The patient received Shingrix in left deltoid. On an unknown date in July 2019, the patient developed shingles. The reporter consented to follow up and provided contact details. There was a discrepancy in the reported outcome of the event shingles. In database, outcome was mentioned as recovering/resolving and in the database, it was autoloaded as not recovered/not resolved. However outcome of the event is captured as autoloaded in database.
Client fainted, client was monitored for an additional 20 minutes.  Client had not eaten today. Client was given juice and crackers. Client said he had a history of fainting with medical procedures. Client left clinic with his Grandmother.
Left upper arm swelling, heat, erythema itching and pain. Seen in Urgent Care, treated with OTC Zyrtec, Hydrocortisone, Ibuprofen, ice + elevation.
Vomiting, Rash, Dizziness, Light Headed, Tingling from the waist up
After about a week or less following each shot of the COVID-19 vaccine, my menstrual cycle began to experience SEVERE irregularities. As someone who has been on the same birth control for many many years (brand/type is NORG-EE oral contraceptives), with no previous issues and an extremely regulated cycle, the effects I experienced were far from normal. My periods came a week early, and lasted for the entirety of the rest of the cycle (totaling 2 weeks of bleeding). The bleeding was extremely heavy containing intense and large clotting for the entirety of the period. Aside from losing a tremendous amount of blood, I have experienced heavy cramping in the lower abdomen and lower/mid back regions both during these periods and even sometimes when I am not bleeding at all. These side effects coupled have caused me to feel fatigued to the point of feeling like I needed to pass out, and due to this I adopted to taking iron supplements daily during the irregular bleeding (chelated iron, 18 mg capsules as recommended). As a result of this concerning symptom, I scheduled a visit to see my primary OBGYN, and was told that this is a common issue that they have been seeing following patient vaccinations. It is my hope that my periods will be regular this month, but for now I am unsure that this issue has resolved.
Immediately following injection, on the way home in the car, the injection site began to itch.
Patient presented to ER s/p being given EPIPEN injection, stated received flu vaccine to left delt at 0730, at 0800 felt tightness in chest, short of breath and had 1 episode of vomiting, given EPIPEN injection and brought to ER for evaluation.
Comes with RA swollen, red, and warm to touch on 06/16/05. DX secondary to DTaP (Cellulitis) TX with Keflex 250mg/5ml 1 tsp Q 6H x 7 Days. warm compresses.
CHEST PAINS, RED ITCHY BUMPS, HIGH BLOOD PRESSURE, VERTIGO, DIZZINESS, ONGOING MIGRAINES, LIGHTHEADEDNESS
Swelling 1cm X 1cm L thigh (lower),erythema, fever 102.7F, irritability.
Pt had  developed redness, itch, around the injection site and spread down to the elbow.
About a 2 inch red raised ring came up around the injection site. It was warm to the touch and tender for the first day. Now it's a little itchy, but not as sore or warm.
pt having extreme pain in arm and it's causing nausea and also mentioned dizziness- she called me at about 4 hours post vaccination
1/26/22: 10:30 - 11 pm - I felt a lot of pressure on my temples and gradually moved to the front of my head and eyes on the way to bed. The pressure was consistent the entire night. 1/27/22: 5:30 - 6:15 am - It was very weak, hard to wake up and get out of bed (felt very heavy), pressure from last night was still present. 1/27/22: 8:00 - 11 pm- Extreme fatigue (couldn't lift my head, arms, couldn't move my legs or walk without support from someone else), extreme labored breathing ( have to sleep on my sides and couldn't breathe on my back), pressure in the head (continued),  swollen left armpit (couldn't put the arm down). Constant deep sleep (during symptoms would subside other than breathing on the back and swollen armpit held at an angle). Couldn't walk without a cane after long nap periods and all the symptoms would come back even worse.  These symptoms have slowly started to improve like swollen armpit ( symptom left 2/1/22)   I began to gain a little bit more strength in the mornings, but once I exert any energy by walking or moving (even while sitting) my symptoms would return.  The return of symptoms would include labored breathing, extreme chest pains, pressure from temples to eyes.   These symptoms have been consistent and ongoing since 1/27/22 and are continuously present. As a result, keeping me from going to school or work.
General: Fatigue, chills, aches, nausea Site: heat and swelling at injection site, extremely sore upper arm lasting >24 hours
Patient received the expired vaccine on 31-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine on 31-Mar-2022) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter mentioned that this incident was because of miscommunication, as a coworker told there were some lot numbers whose expirations dates had been extended.  No treatment information was provided by the reporter.
Patient returned on 09/23/21 to fill a prescription for methylprednisolone 4mg dose pak.  He reported that he experienced local pain on arm which he received his COVID Pfizer vaccine (left arm) and on Sunday 09/19/21, itch was also present with hives.  He was seen by the doctor on 09/23/21.
injection site was itchy; injection site was hard; injection site was peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 54-year-old female patient received bnt162b2 (BNT162B2), on 27Jan2021 as dose 2, single (Lot number: PAA156051) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "concussions", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "contusion", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "She had an accident" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections; "torn rotator cuff" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections. There were no concomitant medications. Vaccination history included: bnt162b2 (First dose Pfizer Biontech covid 19 vaccine: 05Jan2021, Lot: EL0149 (populated in formal field), Expiration: unknown, NDC: unknown, after all the covid vaccine doses she was given, where the injection site was itchy, hard, and peeling.), administration date: 05Jan2021, when the patient was 51-year-old, for COVID-19 Immunization, reaction(s): "injection site was itchy", "injection site was hard", "injection site was peeling". The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "injection site was itchy"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "injection site was hard"; VACCINATION SITE EXFOLIATION (non-serious), outcome "recovered", described as "injection site was peeling". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site swelling, vaccination site exfoliation.  Additional information: she took all of the Pfizer covid vaccines including the booster. States that when the injection site was healing it was itchy, hard, and she took a Tylenol. It took about 3 or 4 days to recover after each dose of the covid vaccine. She did not pay attention to it. They told her to exercise and move her arm around. She was in a rehabilitative facility and did not get the doses from her doctor.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298937 same patient/AE, different product;US-PFIZER INC-202300299879 same patient/product/AE, different dose number;
A nurse reported that a female, inadvertently, received a triple dose of Typhoid Vaccine, USP, Heat Phenol Inactivated, on 6/4/99, and subsequently, developed an injection site reaction characterized by redness and soreness which persisted as ot 6/10/99. This is 1 of 2 pt's from this facility to experience this event following receipt of this vaccine, lot 4988014.
at 9pm the day of vaccine - chills began, low grade fever, pain at injection site, tingling in left thumb and part of palm (only for about 3 minutes), headache.  4/20 continued headache - fever spiked to 102 for about an hour, headache continued.  Took tylenol every 6 hours  4/21, still feel sluggish, but arm is no longer sore, fever is  98.7 and headache is very very mild.
Patient was supposed to be administered the Moderna Bivalent 0.5 mL booster, but patient was administered the Moderna Monovalent vaccine at 0.25 mL.