chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Husband 3rd dose - not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Husband 3rd dose - not immunocompromised) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Husband 3rd dose - not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (Husband 3rd dose - not immunocompromised) had resolved.            The concomitant medications were not reported. It was reported that the patient, who was over 80 years of age at time of vaccination and was not immunocompromised, had received third dose of vaccine (No date, dose, lot number or route of administration was reported for third dose). No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received on 03 Sep 2021 included no new information.
Patient in recovery for approximately 3 minutes.  Patient suddenly slumped over and unresponsive.  Patient did not respond to painful stimuli immediately.  After approximately 20  seconds patient inhaled deeply, opened eyes and was confused as to where he was.  VSS. Rapid response called and patient transported to emergency department as per protocol.
Nerve pain; Muscle pain; swollen joints; facial symptoms; heavy legs; shouting pain in the legs; This case was reported by a other health professional via call center representative and described the occurrence of nerve pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (1st dose received in August 2019, refer the case US2020032209 ).   In November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain. On an unknown date, the outcome of the nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, myalgia, swollen joints, ill-defined disorder, heaviness in leg and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 2nd dose the patient experienced nerve pain, muscle pain, swollen joints,facial symptoms that had never had before, heavy legs and shouting pain in the legs. The patient still had these symptoms.  The reporter did not consent to follow up.
Post covid I was diagnosed with atrial flutter (no previous heart issues prior to covid infection). . No PVCs. Within a week of receiving booster dose of j & j,  I developed PVCs every fourth beat resulting in a need for short term beta blockers. Metropolis 25 mg rx split for 12.5 mg dose daily. Strips were recorded via Watch and submitted to cardiologist for diagnosis. PVCs continued with medication at reduced rate for approximately 3-4  weeks and then dissipated. No way to know if medication improved PVCs or if  they dissipated naturally after initial vaccine effects.  This did not happen with first dose of j & j in March 2021. As PVCs have  dissipated with medicine, I have begun to titrate off of beta blocker to evaluate situation.
Feeling lightheadedness an hour after receiving vaccine. Called pt to follow up and she is feeling better.
I began having symptoms on September 20 (symptoms eventually included post-nasal drip, sore throat, cough, brief fever, pulse rate elevated by 20 beats per minute, headache, some muscle aches, fatigue). On September 21 I went to the clinic for a PCR test and tested positive for Covid. I had a telehealth consult at the clinic on 9/21 and they prescribed Paxlovid. I took the course of Paxlovid. No rebound, no recurrence.
Your arm hurts a lot/ pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-OCT-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that the vaccine was called Shingles and there were 2 doses, it was his/her turn on November 2 of this year. The patent stated that the arm hurts a lot, but it was worth two days of pain. Additional supportive information: The follow-up would not possible as no contact details were available.
Very strong feeling of weakness, many times of the day, almost to the point that I thought I was going to faint. It started 5 days after vaccination, and lasted for 3 weeks.
she can't walk; a little sniff; She has an enlarged heart; she's been having a fever recently; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (she can't walk), RHINORRHOEA (a little sniff), CARDIOMEGALY (She has an enlarged heart) and PYREXIA (she's been having a fever recently) in a 104-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced GAIT DISTURBANCE (she can't walk), RHINORRHOEA (a little sniff), CARDIOMEGALY (She has an enlarged heart) and PYREXIA (she's been having a fever recently). At the time of the report, GAIT DISTURBANCE (she can't walk), RHINORRHOEA (a little sniff), CARDIOMEGALY (She has an enlarged heart) and PYREXIA (she's been having a fever recently) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 103 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Doctor said she should get a booster dose of the vaccine, but they haven't been able to get her to the hospital.
3RD DOSE GIVEN WAS MODERNA - INITIAL 2 DOSES WERE PFIZER. PT DID NOT HAVE A REACTION AND COMPLETED OBSERVATION TIME.
Starting on April 19, 2021 to date, I have had extreme swelling in my eyes and lips.  In addition, my lips have been drier than they ever have previously (dried, cracking, etc.) and have had welts and the outer edge of both my upper and lower lips.  I have also had "raccoon eyes."
pt recvd vax; 2 hrs later, pt woke up crying; high pitch scream; did not stop crying for 4 hrs; t 104.9; rt leg (site of acthib) was red & swollen; sent to er at 4pm;
Mother reports child got immunizations at the school on 8/2/11. Mother noticed redness and swelling 8/3/11. Took her to Dr. office, they it said it was normal. Today redness, swelling has moved down her arm, almost all they way around her arm and down to the elbow (Lt arm). Took back to Dr today, told to go to Health Dept to document reaction.
Delayed side effects- started about 24 hours after Low grade fever (100), my temp usually runs around 97.5. This was high for me.  Itching, swelling, redness around vaccine site Watering eyes Stuffy nose Headache Nausea Muscle aches Lethargy
Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.  The vaccines was stored in freezer, they take out one to two vials and place in fridge each day as needed.
emphysema; This spontaneous case was reported by a patient and describes the occurrence of EMPHYSEMA (emphysema) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMPHYSEMA (emphysema). At the time of the report, EMPHYSEMA (emphysema) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Report A0370537A describes mercury poisoning in a male, now five years old, who received hep B vaccine. This report was received as part of litigation proceedings and has not been verified  by a physician or other healthcare professional. Medical history included cesarean delivery. His mother had a history of asthma; it was not reported if she took asthma medication during pregnancy. Concurrent conditions and concurrent medications were not provided. The child received injections of hep B vaccine on 12/23/1996, 01/21/1997 and 05/21/1997. He also received DTaP on 01/21/1997, 03/21/1997, 05/21/1997 and 02/13/1998; haemophilus influenzae type b conjugate vaccine on 01/21/1997, 03/21/1997, 05/21/1997 and 11/24/1998; IPOL on 01/21/1997 and  03/21/1997; Orimune on 02/13/1998; influenza virus vaccine (unknown date); MMR II on 11/24/1997; and Vairvax on 02/13/1998. The vaccinee's attorney alleged that the vaccinee experienced mercury poisoning due to vaccines administered "from November 1996 through at least February 1998.: Time to onset from immunization and treatment were not provided. This report of mercury poisoning is considered medically serious.
charged syringe with both vaccines at the same time; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a 56-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENACTRA for prophylaxis.   On 6th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received MENACTRA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: A physician assistant reported a coadministration of Menactra and Bexsero at the same time.  The professional charged the syringe with both vaccines at the same time by mistake. The reporter consented to follow up. Additional Supportive Information: The professional charged the syringe with both vaccines (Menactra and Bexsero) at the same time by mistake, which led inappropriate reconstitution technique.
After my second COVID-19 vaccine dose, about 14 hours after the shot I got a fever of about 101 degrees, sweats, chills, and very achy joints and muscles.   The symptoms abated about 12 hours after onset.
This spontaneous report as received from a registered nurse who refers to a patient of unknown age and gender. Patient's medical history was not reported. On 15-SEP-2014 also reported as "today", the patient was vaccinated with a expired dose of PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported) (lot # J011651, exp date: 22-AUG-2014). Concomitant medication was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Narrative:  Patient complained of a tickle in his throat following pfizer covid vaccination. Patient was observed and was no acute distress. Patient was able to leave without intervention.
The day after receiving my first dose of the Pfizer vaccine I broke out in hives all over my body expect for my face, hands, and feet.  I took a Benadryl which relived the itchiness and the hives went away.  The next day when I broke out again...different areas but still all over my body.  This continued to happen until the following Saturday, May 1.  Towards the end each day the hives were smaller and to a lesser degree.  The Wednesday following my vaccine (April 28) I had a severe headache, diarrhea, and nausea.  The headache and nausea lasted one day but the diarrhea lasted for four days.
Patient bent down to pick something up and lost vision in her left eye, described it as a field of black with shooting colors like fireworks in her eye. She presented to her optometrist Dr. She also presented to the ER for further evaluation. She underwent lab work and a CT of the head without contrast. She was diagnosed with a retinal occlusion of the left eye.
Zostavax 0.65 ml SQ was administered on 7/12/13. Patient developed a painful/sore rash that spread up arm to shoulder on 7/14/13. Rash subsided to small welt localized to shot site on 7/15/13.
sleeping more than usual; arm pain; fever; A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose; A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (sleeping more than usual), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), ACCIDENTAL OVERDOSE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) and OFF LABEL USE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) in a 19-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jul-2022, the patient experienced SOMNOLENCE (sleeping more than usual), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), ACCIDENTAL OVERDOSE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) and OFF LABEL USE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Fever, at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleeping more than usual), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), ACCIDENTAL OVERDOSE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) and OFF LABEL USE (A 19 month old patient received their first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8JUL2022  with lot number 017B22A, expiration date 14SEP2022, 0.5mL dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that this vaccine is not authorized for this population, but it was approved for use in people 12 years of age and older.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Mild
36 hours after vaccines with generalized body "jerking" 1x/hr x 4-5 times, mild fever, fussy.
got sick; she missed her appointment because she was sick.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she missed her appointment because she was sick.) and ILLNESS (got sick) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (she missed her appointment because she was sick.). On an unknown date, the patient experienced ILLNESS (got sick). On 05-Apr-2021, PRODUCT DOSE OMISSION ISSUE (she missed her appointment because she was sick.) had resolved. At the time of the report, ILLNESS (got sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information provided included Medrol dose pack.
This last vaccination I had did not cause me any pain afterwards. A few days after the vaccine, my left big toe started to hurt and I didn't pay attention to it. By Tuesday, which was about 4 days later, I realized something was off, however, I was catching a flight so I disregarded it. When I got to my location I went to an urgent care where I then was examined by a doctor, and they stated that there was an unusual rash on top of my foot and they drew blood work. They called me back the next day and confirmed that my Ureic Acid levels were high. The medications that I was prescribed have shown to help out tremendously. I am now feeling much better however, there is still a twinge of pain.
Fluzone HD was accidentally given to a 37 year old patient, no AE; Fluzone HD was accidentally given to a 37 year old patient, no AE; came to a Flu Shot Clinic yesterday and were inadvertently given a Fluzone HD; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA303332 (same reporter).  This case involves a 37 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe) (lot number: UJ283AA, Expiration Date: 29-May-2020)  via intramuscular route in the left deltoid inadvertently on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose and wrong vaccine administered.  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 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.
experienced significant cramping; This is a spontaneous report from a contactable consumer (patient). A elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; Expiration date: unknown), dose 2, via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history include patient remained in the hospital for 5 or 6 days, the concomitant medications were not reported. The patient previously took BNT162B2 (Lot Number: unknown; Expiration date: unknown), via unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunisation. The patient stated that while there is no conclusive link between the vaccine and hospitalization, patient reported that within 12 hours of the first shot had severe abdominal cramping. Within 24 hours patient was in the hospital with a bowel blockage. Patient remained in the hospital for 5 or 6 days with a nasal/gastric tube. The blockage did eventually clear, but after a rather miserable visit. The patient has had blockages in the past and have had two resections which no doubt has left some scar tissue. DR and the patient decided that patient should wait for 5-6 weeks before having the second shot and waited 40 days. Also, patient went on a liquid diet for 2 days prior to and after the second shot. After the second shot the patient again experienced significant cramping, but since there was nothing solid in-patient system, patient did not have a blockage. And patient mentioned one of the side effects (7-8%?) of the vaccine was gastric distress and because of patients scar tissue, distress was a shutdown of bowel rather than diarrhea. In the event boosters were needed patient planned on following the path used above. The outcome of the event was unknown.  Information related to lot/batch number was requested.
Tested PCR positive for COVID 9/3/21 after being fully vaccinated. Admitted to hospital 9/3/21.