chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot number AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 56th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
This spontaneous report was received from a Nurse Practitioner concerning several unspecified patients (age and gender not specified). The nurse practitioner reported that on unspecified dates several doses of improperly stored GARDASIIL 9 (lot # M013636, expiration date 15-FEB-2108)(dosage and route not specified) and (Oka-Merck) PROQUAD (lot# M019232, expiration date 17-OCT-2017) (dosage and route not specified) were administered to unspecified patients. The storage temperature for GARDSAIL 9 was -0.1 degrees Celsius for 38 hours, 20 minutes, -1.67 Celsius for 2 minutes, and 9 Celsius for 13 minutes. The storage temperature for PROQUAD was 11 degrees Fahrenheit for 15 hours 49 minutes. No adverse effects were reported. Additional information is not available. Additional information is not expected.
Patient was observed to be lethargic after being seated with parent in observation area following vaccine administration at 1634. Parent stated that ?she always gets like this following any vaccine injection. We got lunch and made sure to drink plenty before arriving thinking it wouldn?t be as bad. I forgot to bring orange juice today because usually orange juice helps her feel better after shots.? Parent appears calm while communicating about child?s condition. Patient observed trying to rest head in lap and leaning on father?s shoulder, she reported feeling dizzy. RNs offered apple juice while getting 1643 (Sitting) VS BP 90/55 HR58-60, SPO2 98%, Staff assisted patient to wheelchair and transferred to cot to lay down with feet elevated 1649 (laying) BP90/61, HR 80, SPO2 98%, after laying down for a few minutes patient reports dizziness has passed and feels like she is ready to get up. Staff assisted patient to dangle at bedside encouraged drinking additional apple juice and sipping water. Sitting VS 93/63 HR 90 SPO2 97-98%. Patient reports feeling much better at this time. Observation period was complete and patient and parent report feeling ready to leave. Patient ambulated independently from clinic accompanied by parent.
Narrative:  On 4/30/2021 patient received his first dose of COVID-19 vaccination. On 5/4/2021, patient contacted telephone care service and reported the following symptoms: headache, fever, rash, and black-colored diarrhea. Patient was scheduled for primary care visit for follow-up but was rescheduled. Second dose received on 5/28/2021 with no reported side effects.
Patient vaccinated at 10am. Patient immediately slumped over in chair and was guided to the floor. Patient was able to site up and was assisted to chair. Patient reported that she has a great fear of needles and that she did not eat prior to vaccination. Patient given granola bar and juice. Patient vitals remained within normal limits. No injuries sustained. Patient observed for 30 minutes and released after improved. No other significant concerns noted.
Was at home on 12/11/21 and started feeling numbness and tingling on right side traveling to her lips. Seizure. Went to bed. Next day she noticed in the mirror that her face did not look right and watched herself eat. Couldnt open mouth much to eat.  Water ran out of her mouth when she drank it. Felt like she was in the dentists chair. Went to next door neighbor who then took her to ER.  Have never had anything like this happen before.
Hematoma at site. Feverish, swollen glands, body aches, shooting pain in back of arm until hematoma resolved.
From the reports of all those around me on Sunday, 10/30, I was repeating everything I said many times, and asking the same questions in quick succession many times. I do have a seizure disorder but this is completely different. It lasted all day in multiple settings, and I had no awareness of it at all. in fact I cannot remember Sunday at all except in very short snippets.   Toward the end of the day my husband attempted to tell me what a was doing and I burst into tears, I felt I had gone insane overnight.  We reported this to my neurologist who said it did not seem like a seizure.
2 months after I received my 2nd covid shot I started having pressure in my right ear. It gradually got worse and I started having a humming sound in my ear. I made an appointment with an ENT and he prescribed some medicine. I took the medicine for about 4 weeks and went back to the doctor. My condition hadn't improved and he diagnosed with Meniere's Disease. I hadn't had any problem with my ear until after I had gotten the shot.
Breakthrough case admission after 4 vaccines  Pfizer 2/11/21 Lot# EL9267;  Pfizer 3/5/21 Lot# EN6202;  Moderna 9/15/21 Lot# 046C21A;  Moderna 6/28/22 Lot# 054A22A
This literature marketed report was received from the authors of a published article, titled as stated above, and concerns to a 3-months-old female patient.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) orally, (strength, dose, frequency, dose number, lot number and expiration date were not reported), for prophylaxis.  On an unknown date, the 3-months-old patient,female, presented with worsening diarrhea beginning one-week post rotavirus vaccination; she was meeting age-appropriate milestones, had a negative newborn screen (NBS), including Severe Combined Immunodeficiency (SCID) screen, and no pertinent family history; she was admitted for un-resolving diarrhea, electrolyte abnormalities, lymphopenia and hypogammaglobulinemia; Stool rotavirus Protein C Reaction (PCR) was positive (vaccine breakthrough infection and rotavirus infection), 8 weeks after vaccination, on an unknown date, and Total immunoglobulin G (IgG) and IgM were low; the presence of a thymus was confirmed on ultrasound, and esophagogastroduodenoscopy (EGD) and flexible sigmoidoscopywere grossly normal. She received palivizumab, Intravenous immune globulin (IVIG), and Trimethoprim / Sulfamethoxazol (BACTRIM) and fluconazole prophylaxis; the diarrhea resolved one week after hospitalization.  At the time of reporting, the outcome of the events was not reported. The authors considered the events to be related with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) as they stated: "The temporal relationship of vaccine administration with onset of clinical findings, the persistently positive stool rotavirus PCR, and the absence of other clear etiology suggested rotavirus vaccine as the inciting factor for this patient's presentation. This case highlighted a potentially rare subset of immunocompetent patients who could contract rotavirus infection from the rotavirus vaccine."  The authors considered lymphopenia and hypogammaglobulinemia as life-threatening events.   Upon internal review hypogammaglobulinemia was determined to be medically significant event.  A copy of the published article is attached as further documentation of the patient's experience.
Experienced an allergic reaction to one of the preservatives; Experienced an allergic reaction to one of the preservatives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004043 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: REACTION TO EXCIPIENT (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "Experienced an allergic reaction to one of the preservatives". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MULTIPLE SERIOUS ADVERSE REACTIONS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple serious adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple serious adverse reactions was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard  procedure as the case is assessed as non serious
I had headache, sore throat, stuffy nose, achy all over, fever never greater than 100, hair loss, and I felt really awful. I tested positive for COVID-19 at home. I spoke to my doctor and she prescribed Paxlovid.
zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions; zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions; zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.     On or about 17-SEP-2007, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.         On an unknown date, subsequently to  zoster vaccine live(ZOSTAVAX) administration, the pt experienced zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions treated with different healthcare providers. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continued suffering  ongoing injuries, including but not limited to: mental, 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 would continued to suffer such losses, and damages in the future.  By the reporting time, the pt had not recovered form the events. The reporter considered the events to be related to zoster vaccine live(ZOSTAVAX).
I do not know if this diagnosis is due to covid vaccine or not, but wanted to check it out. 4/3/21 redness at left eye; Urgent Care described as pink eye; gave me polymyxin B-TMP eye drops 4/7/21 redness at left eye; Urgent Care again said pink eye and did negative covid test; prescribed Ciprofloxacin Ophthalmic  4/21/21 Went to Opthamology Associates because still red/pink.  diagnosed as Episcleritis of left eye and prescribed Alrex 0.2% eye drops 4/23/21 called Opthamology Associates because now left eye lid sore and swollen.  told me to continue with drops and keep upcoming appointment on 4/29/21 and call if emergency occurs before then. and use hot compresses.   As of today, may be a little better.
At time of injection,  left arm was sore and small welt appeared that went away after about 3 days. On 1/6/2021 I noticed a welt at injection site that was hot and felt hard. Welt has continued to spread on arm, some elbow and arm pain on left arm.
Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA); This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) to be related.    No concomitant and treatment medications reported.  Company comment: This case concerns a 66-year-old female patient with no medical history provided, who experienced serious unexpected event of  moderate Autoimmune Hemolytic Anemia (IgG-mediated). The event occurred after the administration of the second dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown. The rechallenge is not applicable as the event occurred after the second vaccination and the outcome was unknown at the time of this report. No additional details regarding the clinical course of the event was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-year-old female patient with no medical history provided, who experienced serious unexpected event of  moderate Autoimmune Hemolytic Anemia (IgG-mediated). The event occurred after the administration of the second dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown. The rechallenge is not applicable as the event occurred after the second vaccination and the outcome was unknown at the time of this report. No additional details regarding the clinical course of the event was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
BEXSERO given 3/9/17. Urticaria over B/L upper and lower extremities on and off from 3/11/17 until today. Tried hydrocortisone cream W/O relief. Tried CLARITIN 10 mg 1 time, unsure if it helped as urticaria comes and goes.
My deep pain ( aching ) is mostly in my chest, neck and between shoulder blades. Not stabbing pains !  Intense ache in these areas. Is this normal?
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that on 16-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 INJ (lot # J006242, expiration date 03-AUG-2014), 0.5 ml, intramuscular. No adverse effects were reported. This case is linked to case MARRS # 1408USA015389 (same reporter link). Additional information has been requested.
Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On 18-Oct-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient received the booster dose. The patient had no any adverse event post administration of expired vaccine.  Treatment information was not provided.
8/1/08 patient describes swelling of his arm from the elbow to shoulder and swelling across 1/2 of his chest, Nausea, pain, fever, lethargy
Patient referred for left upper extremity pain and weakness. She states she had 2 "shots" about 2 weeks ago for pneumonia and tetanus (dates and vaccines confirmed via Statewide Immunization System) and since then has had pain and swelling at the site. She said it was very red for the first few days after the shots and this has abated somewhat, but it remains very painful and this pain limits her use of the arm. She says it feels weak but this is due to the pain. She thinks she might have had fevers but is not sure and hasn't measured them. No blistering, no drainage. The pain is more in the upper arm/deltoid region than her shoulder.
01/20/22 presents to ED for "generalized weakness, fatigue, decreased PO intake and weight loss". PMHx of "HTN, hyperlipidemia, hyperthyroidism, and AIH (Dx in May 2019), recent diagnosis of COVID-19 on 12/31/21"
Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous report receive from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EL9626) via an unspecified route of administration on the left arm on 28Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included ongoing Reflux. Concomitant medication included esomeprazole sodium (NEXIUM). Patient previously took BNT162B2 on 07Jan2021. On 28Jan2021 20:00 the patient experienced slightly nauseous, slightly dizzy, thinks it activated her reflux and clogged up. Seriousness was reported as non-serious. Outcome of events was recovering.  No follow-up attempts are possible. No further information was provided.
Mild swelling, erythema around eyes, blotchiness on back. BENADRYL given, 12.5 mg, po. "Observed for a few minutes." Some of redness around eyes did resolve.
Patient received Influenza vaccine in her left deltoid this am at. Patient began to experience a mild peripheral parenthesis of her left lateral foreman. This paresthesia changed its quality to that of a mild tingling/prickling within the same initial area. NO SOB or headaches. Patient monitor for 30 mins and then discharge as she had no compromising symptoms/signs. PT peripheral paresthesia began to fade.
My last menstrual cycle started on June 15th and ended on the 19th as usual.  I received the shot on June 25th at 10am.  36 hours after receiving the vaccine, I passed a 2? x 1? clot .   I have always been very regular, so this is extremely irregular.
Developed chronic degenerative ataxia in 1999 and feels AVA immunizations in 2003 weakened his immune system to allow the condition to worsen. Causality assessment---no temporal relationships.
RECEIVED THE VACCINE  2:00P.M. MONDAY  DECEMBER 08, 2008. TUESDAY MY ARM IS SWOLLEN AND VERY RED AND HOT/
pts mom called 22JUN92 @ 2PM & stated pt had to be taken to ER on 19JUN92 PM; t>102; also found to have viral throat infect @ MD 21JUN;
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received dose from vials beyond 30-day use by date) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 23, 2021, patient administered expired product (received dose from vials beyond 30-day use by date). On Jun 23, 2021, administered expired product (received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vial: May 7, 2021.