chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant medication was not reported. Staff gave patients vaccines past the use dates. The use-by date of vaccine was 18-Jun-2023. Patient received vaccine at administration site 2. Treatment medication was not reported.  This case was for the 21st patient out of 47 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
After receiving vaccine and during monitoring period, patient walked up to check out table and fall witnessed by RN at 16:25. Patient unconscious for 10 seconds, later reported feeling dizzy and having blurred vision prior to fall. Denied any other symptoms once conscious. Initial vitals obtained: BP 100/50, Pulse 80, O2 Sat 97%. Patient alert and oriented. Given gatorade and remained lying down. EMS called and arrived to scene to assess patient. Patient denied transfer to hospital, monitored for additional 30 minutes at vaccine site. Additional set of vitals obtained prior to patient exiting facility: BP 118/84, Pulse 75, O2 Sat 99%.
11JUL97 pain joints & swelling of arms & hands-resolved p/3 days but left w/arthralgia of elbows, wrists & all finger joints x/thumbs;placed on pred;swelling occurs w/sharp pain;paresthesia in middle finger & stiffness & discoloration;
Chest pain with troponin elevation upon presentation to pediatric ICU Myocarditis diagnosed by MRI Treated with motrin
Received my second vaccine on Tuesday January 26. On Wednesday afternoon had a mild headache and later that evening I experienced shortness of breath and an asthma attack. I took my inhaler. I never missed any work due to this incident.
dose number=3; painful; Visibly swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number=3"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "painful"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Visibly swollen lymph nodes". The events "painful" and "visibly swollen lymph nodes" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain, lymphadenopathy.  Additional information: Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Heart inflammation, racing heartbeat, chest tightness,  chest pain, breathing trouble, left leg swelling, aches pains, chills, extreme tireness
1219 flushed. BP 164/101, HR 107, Resp 19, Sats 97% 1255 expressed symptoms resolved 1300 left ambulating for home Second vaccine.
spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months; spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jan2021 17:00 (Lot number: EL3248) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Weight loss" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; MELATONIN; OZEMPIC taken for weight decreased, start date: Oct2020 (ongoing); FLU VACCINE VII taken for immunisation, start date: Sep2021. Vaccination history included: Bnt162b2 (Dose 1, administration time: 05:00 PM, Lot: EK9231, vaccine location: Left arm, Route of administration: Intramuscular), administration date: 22Dec2020, when the patient was 57 years old, for covid 19 immunization. The following information was reported: RASH MACULAR (non-serious), RASH PRURITIC (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash macular, rash pruritic.   Additional information: Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101701174 Same patient/Vaccine, different event, different vaccine dose
Information has been received from a 60 year old female who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). On 11-JAN-2011 the patient started experiencing muscle pain in the arm injected. No treatment was given for this adverse event. Patient did not seek medical attention. At the time of reporting, the patient was not recovered. No further information is available.
Patient started feeling numb on the left side of her face about 30-40 minutes after vaccine was given. She has received the first 2 doses of moderna and this was her third. Told patient to go to an urgent care center to be safe. No other adverse effects.
No other adverse reactions are reported; The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago) and NO ADVERSE EVENT (No other adverse reactions are reported) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, 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 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No other adverse reactions are reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago) and NO ADVERSE EVENT (No other adverse reactions are reported) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No other adverse reactions are reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant information was reported.  A dose of Moderna Bivalent Covid-19 vaccine that was taken out of the refrigerator at 10:30AM on 11 Jun 2023. The vaccine was punctured and given to 2 patients appropriately on 11 June 2023 however another dose of vaccine was administered to a patient on 12 Jun 2023 at 11:30AM.   The patient received his first dose of the Moderna Monovalent vaccine on 25 Feb 2021 lot number 014M20A expiration date 12 August 2021 injection site was not known, and no adverse reactions.  Second dose of the moderna Covid-19 vaccine on 26 Mar 2021 lot number 008B21A expiration date 10 Sept 2021, arm of administration was not known. No adverse reactions with it.   First dose of the Moderna Covid-19 vaccine on 3 Nov 2021, lot number 939903 expiry date 3 Nov 2022. Patient does not know arm of administration or of any adverse reactions.   Bivalent Moderna Covid-19 vaccine on 14 Oct 2023 Lot number was not reported. Expiration date and arm of administration are not known. No adverse reactions with it. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728905 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728905:(patient 2)
No reaction on the injection site until 8 days after the vaccine. Arm is now significantly red, itchy , hot at at times it feels hard.  urgent care prescribed Benadryl,  Prednisone (3 tables) and an antacid for 3 days.  Strong headaches on an off, and flue like symptoms but just for a couple days.
Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) 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.   On 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-SEP-2022 Reporter's Comment: The Medical Assistant reported that the patient received Bexsero vaccine was exposed to 29.8 F. The reporter did consent to follow up via mail. Additional supportive information: The Bexsero vaccine temperature was exposed 29.8 F, which led to incorrect storage of drug. This was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132077:Same reporter. US-GSK-US2022132076:Same reporter. US-GSK-US2022132078:Same reporter. US-GSK-US2022132075:Same reporter.
pt went home and within the hour was in cardiac arrest. daughter does not feel it is related but wanted to report it
10/27/06 received immunization. onset 11/05 of numbness and tingling in hands and feet. Hospitalized 11\8. No hosp docum of parasthesias. Readmitted 11/27 with numbness and tingling. Received testing and neuro consult. Pt stated r/o Guillian Barre. Continues to have problems. 12/27/06-records received and reviewed for DOS 11/27-11/30/06 DC DX: Peripheral neuropathy possible due to flu shot Prostate cancer borderline dyslipidemia EMG:nerve conduction and late response studies are consistent with peripheral neuropathy, mild to moderately severe, predominately sensory type with mixed features of axonal loss and demyelination.  PMH: cancer of prostate, status post irradiation treatment, 2 laminectomies and cholecystectomy.
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, the patient was inoculated with zoster vaccine live ZOSTAVAX (dose, anatomical location, route of administration, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's inoculation, the patient was treated by nurse practitioner for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a Licensed Practical nurse refers to a 2 month old patient. The nurse reported that the patient received PEDIARIX (manufacturer unknown) and PREVNAR 13 (manufacturer unknown), ROTATEQ and RECOMBIVAX HB (dose, route not reported) on 27-AUG-2014. The nurse mentioned the patient was supposed to receive (OMPC) (PEDVAX HIB), but received RECOMBIVAX HB in error. No adverse symptoms were reported. Additional information has been requested.
Patient was given Arexvy and Fluzone HD. She is under 60 years old. No adverse events have been reported.
A series of rashes on my right arm not the arm where the  injection occurred. I later looked it up and online it said it?s called ?Covid arm?. I have pictures as well. That occurred on March 1, 2021.,  3 days after my second dose. The second series of rashes happened  March 9, 2021. They?ve all cleared up now. No extreme pain just uncomfortable and itchy. They took less than 2 days to disappear.
Left eye swelling/ Left eye swollen; Pain when she blinks/ Left eye in pain when she blinks; Itching/ Left eye itchy; Caller states this has progressed/ It progressed today this morning, and is more swollen; This is a spontaneous report from a contactable consumer (patient herself). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EW0180, Expiry date was not reported), via an unspecified route of administration on 23Jun2021 as (at the age of 26 years old) dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported.  The patient states she woke up on 24Jun2021 morning the patient experienced left eye swelling/ left eye swollen, pain when she blinks/ left eye in pain when she blinks, itching/ left eye itchy, she states this has progressed/ it progressed today this morning, and was more swollen. She wanted to know if this was a common or rare side effect. She wanted to know what she should do about her side effect. She wanted to see if there was anything she can do. Advised to consult with health care practitioner. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 10 year old white female, with unknown drug reaction/allergies, no adverse events following prior vaccinations and no illness at the time of vaccination. Vaccination history included the patient received 3 doses of DPT and Hep B on 24 May 1996, 19 Jul 1996 and 13 Sep 1996, 3 doses of Hep B on 24 May 1996, 19 Jul 1996 and 13 Sep 1996. 3 doses of Polio on 24 May 1996, 19 Jul 1996 and 13 Sep 1996, Hep B vaccine (generic) on 22 FEb 1996, 24 May 1996 and 13 Sep 1996. ON 06 Jun 1997 the patient was vaccinated subcutaneoulsy with a 0.5 mL dose of Varivax (Lot # 619271/1338D). On 06 Jun 1997 the patient was also vaccinated with DTP, HIB, MMR (lot # 618890/1247D). On 18 Apr 2006 the patient developed chicken pox. The rash consisted of 100 to 150 lesions (previously reported as greater than 50 lesions) over her eintire body. Most of the lesions were located on the client's arms, face and legs. The rash was itchy and lasted for about a week. The child also had low grade fever. Treatments included Tylenol, oatmeal, baths, vitamin C and anti itch lotion. The patient  did not undergo any diagnostic/lab tests. On 23 Apr 2006 the lesions were scabbed and the patient fully recovered. No product quality complaint was involved. On 03 May 2001 the patient was vaccinated with DPT, MMR II (lot 634427/F1390K). Additional information is not expected.
Starting the first month, abnormally short period and then multiple days of heavy bleeding between periods now for 2 months, which I have never had before and I am a 38 year old. In August, started experiencing severe vertigo (dizziness and naseau) right before my period, which  I have never had before. I am not pregnant and have no other health issues that I am aware of.
Pt stood after getting vaccine.  He then fell, hit his head on the wall, and was caught before he hit the floor.  He began having a seizure (Eyes rolling back, turning red, arms bent stiff and shaking, legs bent backwards, and he expelled urine).  911 was called and pt came around after about 3 minutes.  He was able to extend his legs himself and remained on the floor until paramedics arrived.   He was removed from the facility.
Around 7:25 pm on 11/10/20 Patient received 0.20 ml Pfizer 1st dose in Left arm.  Patient may have gotten only half of the dose due to vanishing needle malfunction . Some of vaccine  oozed out of the  site, the child pulled away as vaccine was administered,. Discussed options to re-vaccinate with site supervisors and both parents. The parents decided to  discuss it with their pediatrician whether to re-vaccinate now or wait until second dose on 12/1/2021.
No adverse event noted after receiving vaccine.  Patient monitored for 30mins. Released to the care of father who had accompanied patient to clinic.
Swelling of Face and Lips. Headache, fever, chills, dizzy. sick to stomach.
Dizzy, Headache, High fever, shaking body, ache pain in arms and legs, nausea.
unable to lift her left (injection) arm / very painful to put on a shirt; severe joint pain in her left shoulder / right shoulder and both hips also have pain/pain; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number GM2Y4, expiry date 10th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th September 2020,refer case US2021002009).   On 20th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 20th November 2020, less than a day after receiving Shingrix, the patient experienced arthralgia. In January 2021, the patient experienced injected limb mobility decreased. The patient was treated with celecoxib (Celebrex). On an unknown date, the outcome of the arthralgia and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the arthralgia and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient was still experiencing severe joint pain in her left shoulder. Her right shoulder and both hips also had pain. The pain was worse at night.  The patient used Celebrex for the joint pain. The patient had blood work done for a rheumatology consult and she saw an orthopedic surgeon on 6th January 2021. The patient was unable to lift her left (injection) arm and it was very painful to put on a shirt. The reporter consented to follow up. This case has been linked with case US2021002013, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002013:same reporter US-GLAXOSMITHKLINE-US2021002009:
The pt experienced 4 seizures less than 6 minutes each. 2 were focal, fever to 101.5. All seizures occurred the day after the vaccines.
No adverse effects were reported; administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S002503 with expiration date in 23-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (C) to 8 C (-3 C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008643: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA008903: US-009507513-1907USA011954: