chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injected expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that storage condition at the time of the excursion was refrigerated storage (temp 38F to 40F). On 24-Jan-2022 vial was moved from freezer to refrigerator. No abnormality was reported in vaccine state change. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each). Vial was unpunctured and no previous excursion was reported.  There was no adverse event reported. The patient had none allergies. It was unknown if the patient had been diagnosed with or tested positive for COVID-19.  No treatment medications were reported.   This case was linked to MOD-2022-497451, MOD-2022-497480, MOD-2022-497474 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow up received contains, added patient demographic, product (dose number, dose and units, anatomical location, route of administration) and narrative was updated.
2 days after receiving the vaccine, patient developed right axillary pain and axillary webbing.  she was seen in the office and exam showed axillary webbing but no axillary mass or redness.  case discussed with specialty who recommended watchful waiting.  Pain and webbing continued and patient had a cat scan which was normal except for a 0.9 cm right axillary node.    at this time she continues to have mild discomfort and webbing.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with VARIVAX (Merck) on 02-OCT-2012. Dose, route, frequency and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On 02-OCT-2012 the patient was mistakenly vaccinated with VARIVAX (Merck) rather than Zoster vaccine live. No adverse event reported. The outcome was unknown. Additional information is not expected.
headache; chills; vomiting; This is a spontaneous report received from a contactable reporter(s) (Physician).   A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chills"; VOMITING (non-serious) with onset Feb2021, outcome "unknown", described as "vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I first saw him on 25Feb. His initial presentation included headache and chills.  his mother-in-law also had similar symptoms + vomiting.  He completed the second Pfizer COVID vaccination on 08Feb. He never had abdominal pain, but he did develop icteric sclera, jaundice, acholic stools and dark urine.  A workup included a negative viral hep panel including two HAV IgM, negative ANA, A1AT and a normal CT with normal GB and bile ducts.  TB peaked at 5.5 with AST 916 alt 1865.  He began to feel better the last week of Feb2021 and repeat labs on March 10, 2021, showed TB 1.3 ast 29 alt 102 ap 134.It is unclear if this was an infectious process that was not captured but I worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report.   The adverse event did not result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Unknown. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. No Allergies to medications, food, or other   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hospitalized 12/29/21 2nd Pfizer covid vaccine 2/14/21, EL9267 LOT, IM L arm 3rd Pfizer covid vaccine 8/30/21, FD8448 LOT, IM R arm
Did not give Bivalent as the 3rd dose. gave regular under 5 dose -no reactions
I noticed my heart felt different about 2 weeks after my fist vaccination. What I noticed was my heart felt like it was working harder. it Felt like it was palpitating differently that it had been before. I didn't schedule an appointment for it on it's own, but I went to some already made appointments with my dentist and endocrinologist who took my blood pressure. Every appointment that I went to showed a hypertension level blood pressure. I scheduled an appointment with my family practitioner to have her look into this.
Information has been received from a pharmacist concerning a 63 year old female patient. The patient's concurrent conditions included heart disease. The patient did not have any concomitant medications or drug reactions/allergies to be reported. On 06-MAR-2017, the patient was vaccinated with ZOSTAVAX subcutaneously into deltoid at an angle using 5/8 inch needle (dose, strength and frequency were not provided) (lot # M035696 with expiration date 07-NOV-2017), to prevent shingles. On an unknown date in March 2017, the patient had bump at the injection site which was like a tuberculosis test bump. It was unknown if a treatment was given for the adverse event. No laboratory diagnostics studies were performed. The patient's outcome and the causality assessment between ZOSTAVAX and the adverse event were not provided. Additional information has been requested.
I bled in the middle of my cycle, which I have never done before. I then seemed to start ovulating very late in my cycle, which also has never happened before. I am currently nearly one week late for starting my period, and I have always been extremely regular- every 28 days.
3 days Body aches & chills beginning next day, and fever (day after shot only).
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with doses of VARIVAX (Merck), (dose, frequency, route, anatomical location, lot number and expiration ate were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of two reports received from the same reporter. Additional information has been requested.
Signs and symptoms: cough, congestion, fever, fatigue, and abdominal pain. Treatment:Cefepime IV adjusted to renal functions plus Linezolid 600 mg PO/IV every 12 hrs for total of 7 days with last doses on 11/5/21.
Pt developed emesis, irritability and lethargy on 10/3.  Had some mild fussyness and cold at the time of the vaccines on 9/30.  Presented to ED and found to have communicating hydrocephalus and underwent procedure to fix.
high fever, sweating, shivering, and extremely fast heart beating for 4-6 hours.
Pain in shoulders, both knees, hips, could not raise arms.  No fever, no vomiting or diarrhea ongoing.
Patient wasn't feeling well on Jan 2nd.   felt like someone is pushing on his chest and is Short of breath.  b/p 119-69 P 62 R 26 no temp.  patient evaluated in ED  symptoms subsided quickly and returned to normal environment.  Same similar symptoms occurred again on Jan 6th.  symptoms again subsided quickly.  NO previous history of any cardiac disease.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: EMS called. Patient declined EMS transport as she felt symptoms improving.
Large local reaction on Left arm. Pt advised to ice and take ibuprofen as needed.
Injection was on 6/21/18. She had a large red area on left arm that became swollen, hard, and painful within 24 hours of the injection (6/22/18). The swelling started decreasing around 6/24 - 6/25. The area progressively became purple and softer. On 6/28/2018, she started taking ibuprofen every 8hrs to stop pain and itching in arm. The arm felt better with taking ibuprofen and the area started to fade.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) on 18-OCT-2012. Route of administration and dose were not provided. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. No treatment information was reported. Additional information is requested.
red and warmness on side of chest; red and warmness on side of chest; booster administered subcutaneous/injected in tricep muscle; This spontaneous case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (red and warmness on side of chest), ERYTHEMA (red and warmness on side of chest) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (booster administered subcutaneous/injected in tricep muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (booster administered subcutaneous/injected in tricep muscle). On an unknown date, the patient experienced CHEST DISCOMFORT (red and warmness on side of chest) and ERYTHEMA (red and warmness on side of chest). On 05-Nov-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (booster administered subcutaneous/injected in tricep muscle) had resolved. At the time of the report, CHEST DISCOMFORT (red and warmness on side of chest) and ERYTHEMA (red and warmness on side of chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided.
Patient reports he "felt different in head" and heart rate felt fast.  Reports he has been nervous to get shot.  Arrived to med obs#2 at 17:40.  Vitals at 17:41, HR 93, resp 16, BP 136/88, SaO2 95%.  Patient did not want snack or drink.  At 17:43 patient reports feeling better and heart rate does not feel as fast.  Heart rate at this time wants 85 on monitor.  Vitals at 17:o50, HR 87, resp 16, BP 130/85, SaO2 93%.  Patient's vitals at 17: 59, HR 89, resp 16, BP 127/83, SaO2 95%.  Patient left at 17:59.  He left with his mother who drove him here.
From initial information received on 02/08/2005 from a physician regarding an adverse event occurring in the USA, it was reported that a six month old male patient received his third dose of Acthib, lot number UE114AA, administered intramuscularly in the left thigh, as well as a dose of Prevnar, administered intramuscularly in the right thigh on 04/30/2004 at 12:00PM.  Seven hours later, at 7:00PM, the patient developed hoarseness, labored breathing and was "sensitive to noise".  Per the reporter, the patient is better now.  The patient recovered from these events.  Follow up report was received on 08/30/2005 from a healthcare professional.  The day after the events, the patients mother spoke with a nurse via telephone and reported the events.  She stated that by 7:00PM, the patient had hoarseness and was quite sensitive to noise.  At the time of the call the patient's mother reported that the patient was much better.  She denied that the patient had hives and reported that he was eating.  His breathing had previously gotten labored, but was improved, although not back to normal.  At the time of the call, the nurse documented that the child could be heard talking in the background.  The nurse advised the mother to treat the patient with Benadryl and Tylenol.  At the follow up pediatrician visit on 08/11/2004, the patient's mother reported that the patient's hoarseness lasted 12 hours and was followed by irritability lasting about 2 to 3 days.  The patient had exposure to a babysitter.  The patient's sibling had an unspecified reaction to an unspecified vaccine in the past.  Additional information was received on 12/01/2004.  No additional information was available at the time of the report.
This case was reported by a healthcare professional and described the occurrence of drug exposure during pregnancy in a 20 year old female subject who was vaccinated with Flulaval for prophylaxis. Concurrent medications included Prenatal vitamins and RHO D immune globulin Rhogam. On 9 January 2007 at 13:00 the subject received 1st dose of Flulaval at 0.5ml, intramuscularly in the right arm. The subject was 30 weeks pregnant at the time of vaccination. The Flulaval administered to the subject was given 28 days past the opening of the vial. This was considered to be a medication error. The healthcare professional considered the events were clinically significant 9Or requiring intervention) (OMIC). No adverse events were reported.
really bad chills; nausea; my arm was sore at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (really bad chills), NAUSEA (nausea) and VACCINATION SITE PAIN (my arm was sore at the injection site.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (really bad chills), NAUSEA (nausea) and VACCINATION SITE PAIN (my arm was sore at the injection site.). At the time of the report, CHILLS (really bad chills), NAUSEA (nausea) and VACCINATION SITE PAIN (my arm was sore at the injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
NO KNOWN ADVERSE EVENTS. PATIENT WAS CONCERNED THE SYRINGE MIGHT BE CONTAMINATED.
MYOCARDITIS; COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; This spontaneous report was received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1395661) and concerned a 40 year old male of unknown race and ethnicity. The patient's height and weight were not reported. The patient had no medical history, no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAY-2021 to left arm for prophylactic vaccination. The patient had no concomitant medications.  On 11-MAY-2021, the patient experienced myocarditis. He visited emergency room and underwent computerized tomogram (CT scan) and electrocardiogram (EKG); the results came up as myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the events. This report was serious (Other Medically Important Condition).; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1395661) concerned a 40-year-old man (ethnicity unknown) who experienced myocarditis one day after vaccine. The patient had no medical history, no known allergies and no current illness at the time of vaccination. The patient had no concomitant medications.  On day 1, the patient experienced myocarditis. He visited emergency room and underwent computerized tomogram (CT scan) and electrocardiogram (EKG); the results came up as myocarditis. The patient recovered. Information is limited in this case, and the occurrence of myocarditis could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. More information will be requested if contact information is available.
Injection site red, hot, itchy,  swollen, swelling about the size of a golf ball, area of redness, and itchy area about the size of a grapefruit,  Used Ice, Tylenol,  antihistamines and H2 blocker to treat. Resolved about day 10. I did feel the injection site was a bit low and also provider did not hold injection in arm after injecting, small amount of serum noted to leak out of injection site. ? SQ involvement vs deltoid muscle.
I contracted COVID-19 about a month after my fourth booster shot. Symptom onset 2022-05-08, confirmed by test 2022-05-12. I had acute symptoms for a month and am still experiencing periods of exhaustion and body aches.
During administration of vaccination, pushed the punger of the 1ml 25g 1inch VanishPoint Syringe feeling the plunger push to completion. Pulled the syringe out of the deltoid. Medication did not finish injecting in to the arm and instead sprayed outside of arm, and the needle did not retract. Confirmed the plunger was all the way down at this time. Administered second injection within 15 minutes to ensure patient receives full dose of medication. This was performed without incident to left deltoid. Patient waited full 15 minutes without adverse reaction. Patient advised to monitor for any adverse reaction and report to PCP if experiences any adverse effects.
felt pain and pressure running up the arm into the neck and side of the face; felt pain and pressure running up the arm into the neck and side of the face; pain in her head; She had the pain in her head and sinus area; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 Immunization. The following information was reported: NECK PAIN (non-serious), FACIAL PAIN (non-serious) all with onset 30Mar2021 02:30, outcome "recovered" and all described as "felt pain and pressure running up the arm into the neck and side of the face"; HEADACHE (non-serious) with onset 30Mar2021 02:30, outcome "recovered", described as "pain in her head"; SINUS PAIN (non-serious) with onset 30Mar2021 02:30, outcome "recovered", described as "She had the pain in her head and sinus area"; CHILLS (non-serious) with onset 30Mar2021 02:30, outcome "recovered", described as "chills". Therapeutic measures were not taken as a result of neck pain, facial pain, headache, sinus pain, chills.  Additional information: The patient received any other vaccines 4 weeks prior to the COVID vaccine was unknown. The patient did not received any medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Reported as no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash, fainting spell, double vision, ear aches, stomach irritation, fatigue.
One day post PCV-13 upper arm started to turn red and swell. Has gotten a little bigger each day and on 27 Apr it measured 4x3 inches. Area is pale red and slightly warm to touch. Full ROM. No systemic symptoms or altered sensation. No fever. Treated with ibuprofen and cool compresses with complete resolution on 29 Apr. LOC swell, Mass and lump, Lf up limb.
Pt noticed redness and swelling in left arm morning after vaccine, Pt came to pharmacy on 11/21, Rph noted large, red, swollen area on arm that was warm to the touch. Advised pt to take BENADRYL to stop reaction.
This dose was given in error. This was the patient's third dose of MenACWY - pt. presented to get MenB ( Bexsero).
I was supposed to have my menstral cycle 2 days after my first vaccine, and it never came. I experienced swelling and pain in my left lymphnode (armpit) and completely skipped my April period.
Pt. became irritable, lost his appetite, and got a very high fever of 103.4 causing extreme restlessness and I had to take him to the ER. His blood pressure was 145/122. They were able to get his fever down at the ER with Ibuprofen and Tylenol but was still 100.0 when we left.  He has had an ear infection that had been treated with Cefdinir and he was getting better. Since he got the Prevnar 20 vaccine, he has not wanted to eat, only nurse, and has had a fever ever since.
my nose is sore; Both of my forearms now itch; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (my nose is sore) and PRURITUS (Both of my forearms now itch) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced NASAL DISCOMFORT (my nose is sore) and PRURITUS (Both of my forearms now itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) for Itching, at an unspecified dose and frequency. At the time of the report, NASAL DISCOMFORT (my nose is sore) and PRURITUS (Both of my forearms now itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included diphenhydramine cream. No Concomitant medications were provided
Painful lymph node swelling in armpit and painful lymph node swelling under chin. Injection of Td was in right shoulder.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 29-AUG-2017, the patient was inadvertently vaccinated with one expired dose of ROTATEQ (expiration date: 23-AUG-2017; dose, route of administration, and lot# were not provided). There was no adverse effects.