chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received J&J vaccine on 3/18/21 and positive on 1/29/22. Presented to ER on 1/29/22 who presented in septic shock 2/2 left lower extremity cellulitis and osteomyelitis versus septic arthritis of 5th metatarsal.  No complications from COVID19. Discharged on 2/25/22.
On 1/10/2021 at 2 pm, I developed a severe migraine headache where it hurt continuously and severely for the next 30 days, and it then very slowly improved over the next 3 months. I took tylenol/caffeine so that I could move on a daily basis during the 30 days. It was so continuous that I had a doctor visit 1/21/21 where I was prescribed an anti-migraine pain medication, which I did not take. I also did not comply with the instructions to get an MRI.
This initial spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot# L023866 with expiration date 24-MAR-2017; dose was not provided). The vaccine was exposed to temperature of 47.10F for 96 hours. There was no previous temperature excursion. The call was not because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. this is one of several reports received from the same reporter. Additional information has been requested.
Painful arm (becoming difficult to move) beginning approximately 4 hours after injection. Chills beginning approximately 12 hours after injection. Painful headache mostly responsive to Excedrin Migraine (TM). Fatigue, body aches and mildly upset stomach continuing at this time (approximately 20 hours after injection)
Flu like symptoms 24 hours after getting  the 2nd dose of the Pfizer COVID-19 vaccine
injection site pain; injection site swelling; body aches; muscle ache; fever; redness; swelling; feeling unwell; lymph nodes; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EN6207; Expiration Date: unknown), dose 2 via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. In Apr2021, the patient experienced injection site pain, injection site swelling, body aches, muscle ache, fever, redness, swelling, feeling unwell, lymph nodes. They are mostly concerned about the lymph node swelling on the same side of the injection site on the left side and concerned about anything which could treat it and how long would it last.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Neck spasms, upper and lower back pain, pain in upper legs, fever, increase in heart rate allergic reaction to TDA & MMR. Diagnosed with Torticollis, put on Cipro, pain killers and muscle relaxers.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th October 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 17-Oct-2022 Reporter's comment: The medical assistant called to inquired that how to proceed, the expiration date was firm. The reporter did not consent to follow-up. Additional supportive information: The patient inadvertently administered an expired dose of Twinrix in their facility, which led to expired vaccine used.
Fever developed a few hours after vaccines lasting at least 3 days to a week. Patient suffered lethargy and sleepiness after prolonged high pitched screaming. Seizure possible but unknown. Pain, swelling, and redness at the injection sites on thighs.
This spontaneous report was received from a physician and referred to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 11-NOV-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742428, expiration date: 01-SEP-2022, 2 milliliter), orally was administered for prophylaxis and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) cap was twisted and punctured but not administered. It was placed back in the refrigerator and administered to a patient on 29-NOV-2021consumercap was twisted and punctured but not administered (Wrong technique in product usage process). It was placed back in the on 29-NOV-2021 (wrong technique in product usage process and incorrect product storage). No additional adverse event was reported.
Had my first Moderna vaccine on 3/3/2021 and have been diagnosed  with pneumonia in left lung on 3/15/2021. Visited my surgeon who follows up with me every 6 months. She listened to my lungs and said she heard crackles in my left lung. Sent me for a chest x-ray immediately after visit on 3/15/2021.  I am having no symptoms such as coughing, fever, etc.  I?m concerned this could be a side effect of the vaccine. Was also tested for Covid on 3/17/2021. Test result was NEGATIVE.
Fever, between 101.3 and 102.5 at various times for approximately 16 hours. Lethargic for 2 days. Arm sore at injection site for 3 days.
pt inadvertently recv 4th dose of OPV & tetramune 8/19/96 p/recv 3rd dose of each 8/12/96 mom reported that pt was fussy & devel a low grade fever;this event was detected during a retrospective review of medication errors;
Was diagnosed with Shingles.  I had the shingles vaccine about 5 years ago.  The nurses at the hospital said this vaccine likely causes the shingles.
patient was given the Fluzone Quad 0.5 ml instead of the high dose, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was Linked with 2019SA310470 (same reporter).  This case involves a 71 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via intramuscular route in unknown administration site), on 25-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 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 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.  Information on the batch number was requested.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (Administer expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the vaccine was stored in freezer and the pharmacist took out one to two vials and placed in refrigerator each day as needed.  No treatment given to the patient.
Vaccine administered on 06/02/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Symptoms: Headache, nausea, body and joint ache, fever.   Treatment: Tylenol and bed rest     Time course: 18 hours and continuing.
You probably after using my time will have some reason for not allowing me to report this field 18.  Why have you been keeping me from reporting it? Four four weeks after the second Moderna Covid 19 vaccine I gained five pounds a week with no change in diet except I may have eaten less.  Finally, I was wheezing one morning .  I told a friend of mine who is also a retired Doctor.  He checked me over and told me I was retaining water and was carrying at least 15 pounds of water in my legs alone.  i was also carrying excess water in my abdomen. He took me to my doctor, but I was not allowed to be seen until they shove a stick up my nose until I gagged.  After I received the negative results I was allowed to see my doctor.  Should have never told them I wheezed.  Anyway, after seeing me x-rays were ordered and the next day my doctor contacted me.  I am retaining water, IMHO, as a result of the second Mocerna Covid 19 vaccination.    I am now on a water pill.  Weight has come down about 15 pounds in one week.  Only 7 pounds more than what it was when I received the second Moderna COVID-19 vaccine.  I feel I will be able to shed the rest of the water being retained as a result of the second Moderna COVID-19 vaccine.  Cordially, patient Wonder if I will be allowed to report this or be stopped as before.
Covid vaccine inadvertently given one day beyond use date (72 days refrigerated).  Physician aware and they notified parent.  Parents are not redosing at this time
sore throat, right side, blisters on right tonsil; sore throat, right side, blisters on right tonsil; sneezing and runny nose; sneezing and runny nose; felt bad overall/feels like the flu or strep; tiredness; body aches; slept most of the day; stomach pains; sore arm; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 03Sep2021 at 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from 2015 and ongoing. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No family medical history relevant to events. No additional vaccines administered on same date of the Pfizer suspect. No relevant tests. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered on 13Aug2021 for covid-19 immunisation. Caller stated she had second Pfizer injection this past Friday (03Sep2021), stated she had a sore arm on 03Sep2021 and typical things, stated she works at local hospital, stated she was also administering the vaccine, states she was a registered nurse, stated on Saturday the day after the vaccine (04Sep2021) she was tired, with body aches, slept most of the day, states she then had a lot of stomach pain and felt bad overall, states she was still having stomach pains, yesterday (07Sep2021) it started getting worse, felt a sore throat, looked and saw blisters on right tonsil, states there was no fever. She also had been sneezing with a running nose on 04Sep2021, almost feels like the flu or strep. No investigation assessment. All events were not required a visit to Emergency Room or Physician Office. The outcome of event sore arm was recovering, of events tiredness, body aches, stomach pains, sore throat, right side, blisters on right tonsil, sneezing and runny nose was not recovered, of other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), to reported events is possible based on temporal association and known profile of the product.
This spontaneous report as received from a physician, via a company representative, refers to a currently 26-year-old female patient. The patient's medical history, drug reactions or allergies were not reported. In approximately 2006 (reported as 10 years ago), at approximately 16 years old the patient was vaccinated with a dose of GARDASIL (lot #, dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient developed vulvar dysplasia (also reported as bulbar dysplasia) and had 4 unspecified procedures for her condition. The outcome of vulvar dysplasia was reported as not recovered at the time of the report. The relatedness between the event and GARDASIL was not reported.  Upon internal review, the event of vulvar dysplasia was considered to be medically significant. Additional information has been requested.
Within a few minutes of being vaccinated, the patient began to experience a sensation of heavy headedness as well as some visual compromise.  Vital signs within normal limits.
Missed my second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed my second shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed my second shot). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed my second shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative time was 2544 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
concerned they received less than the full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (concerned they received less than the full dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (concerned they received less than the full dose). At the time of the report, ACCIDENTAL OVERDOSE (concerned they received less than the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was given. The patient is concerned that he received less than the full dose because it looked as if his spouse's syringe had more content in it when they received the vaccinations together.
Some side effects; A spontaneous report was received from a consumer, concerning herself, a female patient of an unspecified age, who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced some side effects.  The patient's medical history was not reported. Concomitant medications were not reported.   On 06 Jan 2021 at 09:00 AM, the patient received their one of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date in 2021, after vaccination, the patient experienced some side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event some side effects were considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
local 3cm induration watch resolved in 4 days. Nurse did note some vaccine leaked from syringe on withdrawl unintended.
On the March 16, 2021 health rate went to racing and I passed out in the ER, I was already there with my son. They  release me because I told them to release me. The next morning you I woke up I had sore around and in my mouth. I went to my PCP and they said it was from the vaccine. They then swab my throat and they did it three times and they come back inconclusive. They (doctors) don't know what it is. I am still getting them every now and than.  An now I have two tumors on my liver and they wasn't there in January 2021. They are non cancerous they say.
The day after vaccine, I woke up with swollen large lymph node.  It was the size of a baseball on armpit. Was extremely painful. It went down to about half the size within 3 days. It was aggravating due to irritation from moving arm. It becomes very painful throughout the day. I called my doctor and they said to wait. It hindered me at work. I went back to doctors office and stated its been going on since April. I have pending blood work and  ultrasound due to having to pay for it. Also had a swollen lymph node on 2nd dose as well and is reported.
big red bulge of 2x2 inches at the injection site; It was warm to touch; big red bulge of 2x2 inches at the injection site; It is warm to touch itchy but not painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE MASS (big red bulge of 2x2 inches at the injection site), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE ERYTHEMA (big red bulge of 2x2 inches at the injection site) and VACCINATION SITE PRURITUS (It is warm to touch itchy but not painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LANSOPRAZOLE (PREVACID) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE MASS (big red bulge of 2x2 inches at the injection site), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE ERYTHEMA (big red bulge of 2x2 inches at the injection site) and VACCINATION SITE PRURITUS (It is warm to touch itchy but not painful). At the time of the report, VACCINATION SITE MASS (big red bulge of 2x2 inches at the injection site), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE ERYTHEMA (big red bulge of 2x2 inches at the injection site) and VACCINATION SITE PRURITUS (It is warm to touch itchy but not painful) outcome was unknown. Not Provided      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.   Other concomitant medication reported was vitamins.   Reporter did not allow further contact
an 80y/o male and female patient who received their 1st dose of the Pfizer Bivalent COVID Vaccine in Oct2023 were positive for their PCR test in the past month; an 80y/o male and female patient who received their 1st dose of the Pfizer Bivalent COVID Vaccine in Oct2023 were positive for their PCR test in the past month; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "an 80y/o male and female patient who received their 1st dose of the Pfizer Bivalent COVID Vaccine in Oct2023 were positive for their PCR test in the past month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.