chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Past lot that had also been expired that was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).    Patient age was reported as 32 Year 3 Month. No concomitant medication was provided. NDC number was reported as 80777027399. The lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a health care facility (by an unspecified health care professional) for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Firm swelling of deltoid area to mid-forearm with increased warmth and slight redness, and tenderness along arm.
worst hives on feet only; itching at the vaccination site; swelled up a bit but no big deal; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (worst hives on feet only), VACCINATION SITE PRURITUS (itching at the vaccination site) and VACCINATION SITE SWELLING (swelled up a bit but no big deal) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (worst hives on feet only), VACCINATION SITE PRURITUS (itching at the vaccination site) and VACCINATION SITE SWELLING (swelled up a bit but no big deal). At the time of the report, URTICARIA (worst hives on feet only) had not resolved and VACCINATION SITE PRURITUS (itching at the vaccination site) and VACCINATION SITE SWELLING (swelled up a bit but no big deal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information provided.
Case number PHEH2014US023373 is an initial spontaneous report received from a medical assistant on 19 Nov 2014 with a follow up information received from a medical assistant on 05 Jan 2015. This report refers to a 19 years old female patient. Her medical history and concomitant were not reported. She was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 17 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. Upon follow up received on 05 Jan 2015, the reporter confirmed that no adverse events were reported following the inadvertent administration. No further information was provided. Follow up information received from a medical assistant on 05 Jan 2015: Reporter's comment updated.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 31Jan2023 as dose 1, 0.3 ml single (Lot number: FP7136) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Anemic" (ongoing), notes: Had anemia almost all of her life. Concomitant medication(s) included: FERROCITE taken for anaemia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered" (2023), described as "Had sore injection arm".  Additional information: Other medicines Ferrocite: She is low in iron. It's to help with iron. The patient had no Prior Vaccinations. For the first dose COVID-19 vaccine:  Had sore injection arm. Lasted for a couple days and went away. The soreness didn't come until the next day after shot. With the COVID-19 BV booster, the soreness in the injection arm came right after the shot, immediately. It's still sore, but thought that was normal because of the being sore also with her first COVID-19 vaccine.
About 5 minutes after completing the immunizations, the patient became light-headed and fainted.  I helped her back into her seat, gave her an alcohol swab to sniff to wake her back up, gave her a drink of water, and gave her some glucose gel to eat. The patient regained consciousness, gained color back into her face, and was able to stand and walk after a couple of minutes.
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Here for 4 y/o physical on 4/29/13. Given izs and (L) upper arm swollen, hot, red, 10 cm x 10 cm area when seen on 5/1/13 at 5pm.
Received a dose from a vial with more than 12 hours of punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial with more than 12 hours of punctured) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) 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 EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial with more than 12 hours of punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial with more than 12 hours of punctured) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.
Thickening of tongue; difficulty swallowing; racing heart; This is a spontaneous report from a contactable consumer. A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6205) via an unspecified route of administration, administered in Arm Right on 09Mar2021 08:45 as DOSE 1, SINGLE (at the age of 61-year-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included progesterone; levothyroxine, liothyronine (NP THYROID); bupropion. The patient previously took rocephin [ceftriaxone] and experienced drug hypersensitivity.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 08:45, the patient experienced thickening of tongue, difficulty swallowing, racing heart. The patient received Paramedics on site an self med w/Benadryl. The outcome of the events was resolved on unspecified date on 2021.   No follow-up attempts are possible; No further information is expected.
Fever, sinus congestion, left cheek swelling x 2 days. Dr has prescribed Amoxicillin caps 500mg PO TID x 7 days begining today, 11/07/11.
EXTREME LETHERGY, ELEVATED HEARTRATE, ELEVATED FEVER, NAUSEA, FATIGUE
Pt asked to be vaccinated with Shingrix & Moderna booster on 4/28/22 as a walk in. The pharmacist  administered the immunizations and issued the patient a new Covid vaccine record card because she stated she lost/didn't have her current card.  On 4/29/22 her daughter called and stated her mother had already received a pfizer booster on 4/8/22 and didn't need the Moderna booster. She was concerned about side effects.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Havrix 720 and Havrix 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: 01-Mar-2023 Reporter's Comments:  Medical assistants (MA) reports a patient received an expired dose of Havrix on the day of reporting.  Vaccine expired on 6th February 2023. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix after expiration date, which led to expired vaccine used.
Severe vertigo started approximately 3 weeks after 2nd dose. Everything spins, I cannot focus my eyes, and it is accompanied by mild nausea. So far, it primarily occurs when laying down or when getting up from a laying down position. I have never experienced vertigo in my lifetime, so I?m convinced that this is related to the vaccine. Many others are reporting the same issue.
sleeping a lot; feeling very tired; Very cold, freezing; chills; feverish with temperature of 100 F; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (sleeping a lot), FATIGUE (feeling very tired), FEELING COLD (Very cold, freezing), CHILLS (chills) and PYREXIA (feverish with temperature of 100 F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included GLICLAZIDE (MICROZIDE [GLICLAZIDE]), METFORMIN, ATENOLOL (TENORMIN), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE (NORVASK [AMLODIPINE]) and WARFARIN for an unknown indication, VITAMINS NOS.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeping a lot), FATIGUE (feeling very tired), FEELING COLD (Very cold, freezing), CHILLS (chills) and PYREXIA (feverish with temperature of 100 F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleeping a lot), FATIGUE (feeling very tired), FEELING COLD (Very cold, freezing), CHILLS (chills) and PYREXIA (feverish with temperature of 100 F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 f 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
5x6 cm induration/redness post left arm, tender to palpation, some drainage.  Given cephalexin 500, MEDROL dose pack.
Information has been received from a physician concerning an 18 year old female patient who on 18-JUL-2007 was vaccinated with a first dose of GARDASIL. The physician reported that the patient experienced a fever of less than 101 F within a few days after the injection was given. She was treated with TYLENOL and her fever resolved. No additional information was available at this time. Additional information has been requested.
One week after my first vaccine, I broke out in hives all over my body. After my second dose, I developed left upper arm muscle spasms and cramps, which have not gone away. 3rd dose (booster) fever, chills body aches and left arm spasms.
1st Moderna Covid imm given 3/15 or 3/19, within weeks afterward reported heartburn, early satiety, bloating. 2nd Moderna Covid imm given 4/16, within few wks afterward c/o gurgling stomach, decreased appetite, losing weight, nausea, back pain, loss of energy. Episode in May where he became lightheaded after working around home which was new. Easily fatigued. Had sudden cardiac arrest while sitting at home June 7 witnessed by wife, unresponsive, CPR initiated, taken to hospital, deceased June 10th cause of death myocardial infarction, coronary artery disease per wife
Gas and diarrhea starting about 6 am and low grade fever and overall achiness starting about noon.  Lasted until went to bed about 9 pm
2 1/2 weeks after my Moderna 3rd dose my left leg started really hurting just below back of the knee and also my big toe on left foot turned purple. The purple went away, but the pain in the back of my leg got worse and so I went to see a cardiologist and they diagnosed me with DVT. It was a very large blood clot. I went on a blood thinner for 3 months (Eliquis) and in January I saw my doctor again. I got a CT scan as well to rule out any other issues, and my blood test showed D-Dimer improving; showed the blood clot getting better. I got off Eliquis and started taking baby aspirin. However, I got a D-Dimer again on February 24, 2022 and the test came back high indicating that I still have the blood clot. I am sure my doctor is going to put me on Eliquis again and I will probably need to take it for life. I have a follow-up with my doctor tomorrow on 03/01/2022. I also wanted to add, that about five days after my 3rd dose I started taking Prednisone for symptoms. Also, I am not sure if this is relevant or not, but they did give me a full dosage of Moderna for the 3rd dose, it wasn't the typical booster dosage.
DIARRHEA THAT NIGHT, THEN SHE WOKE WITH OOZING MATTED EYES, WHICH FELT HOT, CLOUDY VISION AND FEELING WEAK TRIED OVER THE COUNTER BENADRYL AND EYE DROPS. THEN WENT TO URGENT CARE FACILITY IN THE AFTERNOON AND WAS PRESCRIBED IODINE (ETODOLAC) AND METOPROLOL FOR ANXIETY. GIVEN A STEROID SHOT AND ALLERGY SHOT.
I had a missed miscarriage at my 15 week check up. Baby had passed away in the weeks prior. I found out about March 10. Pregnancy history - 2nd one - 2016 - normal pregnancy; this was my second pregnancy; due date was August 19th.  I do have to have repeat testing in three months to confirm lupus anti-coagulants result from April 2nd.
Pt had a 4 yr WCC with vaccines on 7/31/13 developed redness, increased warmth, tenderness at both vaccine sites on (L) ant thigh.
Day 8, I woke with a headache, chills, vomited 4 times, muscle aches, and heart palpitations all day until around 8 pm. I couldn't keep food down until then. From Day 8 until yesterday (Day 11), I have been having intermittent episodes of heart palpitations, which is my only serious concern.  I have had a declining number of heart palpitations today, Day 12, but felt I should report these heart palpitations in case this is a sign of a serious complication. Should I avoid receiving the second dose?
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 26-AUG-2015 the patient was vaccinated with an expired dose of M-M-R II (dose, route not reported, lot # reported as J009830 with expiration date 28-JUN-2015). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Patient seen through our urgent care facility today for local reaction to left thigh. Examined by Nurse Practitioner. Oval shaped, pink in color approx. 6 cm in size, localized. Erythema. Area improving per patient's mother, patient afebrile at time of visit.
On 4/18/11 FNP ordered Rotavirus vaccine. MA administered by oral route. Vaccine had expired 4/13/11. Lot # 1470Y. Manufacturer Merck, ROTATEQ. No adverse reactions reported or observed. Pt to be recalled 1-2 weeks to administer repeat vaccine.
Patient stated "I don't feel good. I feel like I'm going to pass out." Patient passed out. When patient came to was shaking and stated she seen spots and felt nauseated. Was pale in color.
PATIENT NOTED "SPOTS" ON LEFT ARM NEAR SITE OF VACCINE 36 HOURS AFTER ADMINISTERED VACCINE
No adverse event - vaccine given SC instead of IM (HPV - Gardasil). When the nurse gave the vaccine- she drew back blood after hitting a vein.  No treatment needed- Nurse placed needle in sharps box & administered a new vaccine.
On Jan . 19, Exactly one week after vaccine (part 1)  vaccine site developed a nickel size red area and about 1 1/2 inch above vaccine site a 2 inch red, hot, itchy patch appeared on my right shoulder. .  There had been no discoloration prior to this . I applied a clean cold wet washcloth to shoulder  area. For about an hour. That stopped itch. Next morning area still looked and felt the same-red, hot, itchy. I again applied clean cold washcloth to shoulder area. For about 30 minutes.  Then applied an over counter cream ( hydrocortisone 1% plus) just to shoulder area.  Used the cream again just before bed that Wednesday night and again Thursday night, only on shoulder. Itching stopped and did not resume. Redness and heat on rash faded each day until completely gone by Sunday January 24th., total of 6 days.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves female patient (age not reported) who experienced she did not feel comfortable, while she received vaccine MENACTRA. The patients past medical history, medical treatment, vaccination and family history were not provided. On 26-Jun-2018, the patient received 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5415AA, expiry date: 16-Oct-2017, via intramuscular route in the right arm along with TDAP. On an unknown date, the patient developed a non-serious she did not feel comfortable, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was also a case of actual medication error due to expired vaccine used. Relevant tests were not reported. Final diagnosis was she did not feel comfortable. It was not reported if the patient received a corrective treatment. The outcome was reported as unknown for the 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. Documents held by sender: none.
Case received from a Healthcare Professional on 28 September 2011 under the reference number 11-0645. The reporter of this case is the same as for case 2011-09412 and 2011-09411. A male patient (date of birth not reported), with no reported medical history and concomitant therapy, had received a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. 5 to 6 hours post-vaccination, the patient experienced eye discharge, eye drainage, flushing and fatigue. The patient's outcome was not reported.
This spontaneous case reported by a consumer and describes the occurrence of pain in extremity  (sore arm), pain (body ache), bedridden, diarrhea (loose stool) and vomiting in a 75-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 4, 2021, patient experienced pain in extremity (sore arm), pain (body ache), bedridden, diarrhea (loose stool), vomiting and pyrexia (fever). The patient treated with Tylenol (paracetamol) for the adverse event(s), at an unspecified dose and frequency. At the time of the report,  pain in extremity (sore arm), pain (body ache), bedridden, diarrhea (loose stool), vomiting and pyrexia (fever) outcome: unknown. Concomitant medications not provided.
Uncontrolled shaking; Nausea, unable to get warm, using furniture to make it to bed.