chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 025C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2022 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that, the vaccines were initially placed in the refrigerator on 19 Jan 2022 and were administered to the patient beyond the 30 days use by date on 24 Feb 2022. The vial did not undergo any temperature excursions.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received contains Non significant information.
Report swelling, redness and hot to touch at injection site with  raised hard nodule 11 hours post vaccination. Treatment included Tylenol, Advil and ice therapy with no improvement. Outcome: Does not interfere with ADLs continues to work.  Will follow-up with primary care doctor.
180 RESTING HEART RATE; RIGORS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown expiry: UNKNOWN) 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 180 resting heart rate, rigors, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 (unit not reported), and Heart rate (NR: not provided) 180 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 180 resting heart rate, rigors and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
5 days p/vax given in the anterior aspect of the lt thigh, induration & irritability devel;an I&D of site was performed in the hosp where pus was obtained
blacked out/ didn't know what was going on; light headed; fever; A spontaneous report was received from a consumer concerning herself, a 69 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blacked out and didn't know what was going on/syncope, fever/pyrexia, light headed/dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Mar 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch number: 040A21A) intramuscularly for prophylaxis of covid 19 infection.  On an unspecified day in Mar 2021, the patient experienced blacked out and didn't know what was going on. She did not lose consciousness. The patient had developed fever and felt light headed. Patient was hospitalized on 13 Mar 2021 due to the events.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, blacked out and didn't know what was going on/syncope, fever/pyrexia, light headed/dizziness were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
No adverse reactions.  This was just a 15 month child who received immunizations meant for a 6 mo old, so not all immunizations that were given were needed and o e missi g vaccine wasn't given.   Mother was alerted and pt will receive their next needed vaccine at next visit
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 07-NOV-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
Itchy rash all over body. Not totally terrible but uncomfortable and bothersome. Taking some Benadryl the last couple of days.   Still hasn't gone away as of 3/14/21.  Never experienced this before and there have been no other changes in my life, i.e. food, soap, clothing, etc. that could be allergens.  All I can think of is the vaccinations.  Will go to a doctor soon if possible.  Just thought I should report this.
inserted syringe into left thigh.  Patient pulled it out before dose could be administered.  Then gave full dose in right thigh(vast lat.)
Patient developed rash along entire body. Treatment of zyrtec, naproxen and hydrocortisone cream has help with body rash, but the injection site rash and swelling is still present. patient stated she had extra soreness in arm, along with swelling, inflammation and soreness in the lymph nodes.
Itching everywhere. Benadryl doesn't help. Skin is hardening everywhere on my body. Rash everywhere.
This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored GARDASIL, exposed to 8.4 degree for 20 minutes and also to temperature of 9.7 degree for 6 hours 20 minutes, intramuscular (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Patient came in for a physcial on 02/01/2022 at 10:00 with Clinic. Patient was needing a booster and Tdap vaccine. I drew up the Moderna Booster without checking the expiration date, it had been open on 1/31/2022 at 8:45am and punchered so it was pass the 12 hours. I gave the booster on her L deltoid around 10:15. When I came back to chart that I gave the vaccine I realized the vaccination was expired. I notified my provider, the patient, the lead MA and Modnera Medical Information Department. The patient had no adverse reaction to the vaccine, she waited in our clinic for 25 minutes after the vaccine was given.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unknown dates, the multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N003703, expiration date 29-OCT-2019, dose, route and frequency were not provided). No adverse effects were reported. The vaccines were stored in the temperature between 32 and 35 degrees Fahrenheit for 5 days. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA015635: US-009507513-1705USA006154.
injection site lump; injection site itching; injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (injection site lump), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE MASS (injection site lump), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, INJECTION SITE MASS (injection site lump), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.
2 hr p/vax red, hot to touch, sore arm @ site; applied ice; soreness & stiffness went up lt side of neck; h/a, sweats felt like running T105 no temp; 16 hr p/shot h/a, soaked night clothes & bed, dizzy, body felt like on fire; hoarseness,
Pt reports getting his flu vaccine at 10 am. Minutes after receiving the vaccine, pt reports he started to experience mild tingly and numbness in his R foot. Pt ignored symptoms until hours later when he states it didn't go away and traveled up to his knee and his R hand.
Patient received two doses of Pfizer COVID-19 vaccine after receiving one dose of Moderna COVID-19 vaccine.
soreness in arm; difficult to lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16-Jan-2021, the patient experienced mobility decreased (difficult to lift my arm). At the time of the report, mobility decreased (difficult to lift my arm) was resolving.    On 17-Jan-2021, the patient reported that pain scale was 6 out of 10. By 18-Jan-2021, it had turned way down to about 3/10 and on 20-Jan-2021, pain was at 0.5/10. Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-076657 (Patient Link).
This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 75-year-old male patient of unknown ethnicity received PREVNAR 13 at 0.5 ml single dose on unspecified date. Medical history and concomitant medications were not reported.  On unknown date in 2014 (possibly in the week before this before) the patient experienced an allergic reaction and went to the emergency room. The physician reported that patient was now ok. Outcome was unknown. Follow-up (21Nov2014): Follow-up attempts completed. No further information expected.
Sick in the head; Floaty/shooting pain in my head; Patient has not schedule the second dose; Missed 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Sick in the head), HEADACHE (Floaty/shooting pain in my head), BLOOD GLUCOSE DECREASED (Sugar went down to 50), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not schedule the second dose) and INTENTIONAL DOSE OMISSION (Missed 2nd dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CYPROHEPTADINE HYDROCHLORIDE (PERIACTIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), PANTOPRAZOLE and MONTELUKAST for an unknown indication.    On 29-Mar-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 FEELING ABNORMAL (Sick in the head), HEADACHE (Floaty/shooting pain in my head), BLOOD GLUCOSE DECREASED (Sugar went down to 50), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not schedule the second dose) and INTENTIONAL DOSE OMISSION (Missed 2nd dose). At the time of the report, FEELING ABNORMAL (Sick in the head), HEADACHE (Floaty/shooting pain in my head), BLOOD GLUCOSE DECREASED (Sugar went down to 50), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not schedule the second dose) and INTENTIONAL DOSE OMISSION (Missed 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose decreased: 50 (Low) Blood glucose went to 50. On an unknown date, Blood pressure measurement: 160 mmHg (High) Blood pressure was 160. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up case received on 8-JUNE-2021 contains significant information.
Menstrual cycle stopped, losing weight. (has not skipped since her first period-July 2006)
Swollen area under arm that recieved the vaccine.  When arm is lifted the swelling "pops" out from the arm pit.  Large width of the swelling almost like a half of an avocado.  When arm goes down into resting position, it goes back up and is painful.
Appearance of hives w/itch day after administration of MMR and Varicella. Tried aloe and coconut oil with no effect.
Gave patient first dose of moderna vaccine. 14 minutes after injection, patient claimed hot flash like reactions on back of neck and down arms. Gave patient a cool compress. Patient kept saying it went away and then would return. Checked blood pressure at 3 15 min intervals with values of 187/101, 192/95, 189/96. Urged patient she needed to seek medical attention. Daughter came and picked up patient with intent of taking her to ER.
Arm swelling, redness and hard for 5 days then turned into a black and blue 1st night headache, fever, body chills and cough  5 days - headache, light headed, cough
By morning after the injection, I was experiencing a severe headache, sore arm, muscles and a mild fever (99-101).   Headache and muscle soreness lasted until about 7 pm that evening - about 12 hours.    All symptoms, except for a sore arm near the injection site, were gone by the next morning.
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers No concomitant medications were reported. On 18-MAR-2021, the subject experienced leg swelling. On 18-MAR-2021, the subject experienced ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg swelling and ankle swelling was not reported. This report was non-serious.
pt devel a raised rash over entire body 2 days p/vax;rash persisted 2 days, began to subside, & was resolved by 3rd day;
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 8/31/21 and 9/21/21. Covid+ 1/23/22. Admitted to ED on 1/26/22 for AMS. Minimally responsive and hypotensive on admission, dx'd w/septic shock 2/2 Covid19 c/b severely hypernatremic & dehydrated w/acute kidney failure, NSTEMI (likely demand), transaminitis and metabolic encephalopathy. Initial labs showed:  Na+ 186, glu 161, BUN 184, Cr. 7.04, Alk Phos 190, trop 0.21, procal 0.57, COVID positive. Transitioned to comfort care. Treated with vancomycin and zosyn. Pt expired on 2/9/2022.
Pt complained of rash that occurred in the first 15 mins was gone by the time the provider saw her arm. Pt complained of numbness in her lower arm and tingling in her fingertips. Pt states that it comes and goes. Pt said that her arm also felt heavy. The numbness and tingling occurred 90 mins after injection
when I received my first Pfizer vaccine I just had a little bit of a sore arm and that was it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: Had COVID-19 over thanksgiving last year (2020), with no hospitalization. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "when I received my first Pfizer vaccine I just had a little bit of a sore arm and that was it.".  Additional information: The patient went to urologist (past this week -  at the time of reporting) and the nurse in the office was shocked that she had her first Pfizer vaccine dose and told her that she should not get the second dose. The nurse said because she had already had the COVID-19 virus and had antibodies already and getting vaccinated could give her a heart attack. The patient was asking if it was true.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given Pfizer booster COMINARTY 1 week too early from the 5 month interval. Gave this booster at 10:03 am on 02/03/22. This RN realized that it was given too early 2 minutes after administering the vaccine when checking the patient's COVID card., and notified the patient and the patient's mother. Then called the Clinic and asked for guidance after early booster vaccine administration. Stayed with patient for 30 minutes after vaccine administration.
Symptoms at 5min. after injection- lightheadedness, nausea, body aches, coughing, wheezing, running nose, rash on stomach + sides. Fever 100 next day. Took Benadryl 25 mg that evening.
Mom presented with 2 year daughter who received routine vaccinations on 1/12/16. Right leg received DTaP (SK, Lot #94F5K), Hib (Merck, Lot # L014426) and PCV 13 (lot # L62074) and left leg received flu vaccine (SK, 4J449) and Hep A (SKB Lot # 423SD). Mom advised redness and swelling began 24 hours after vaccination and increased to 2 in by 1.5 in oval hard red are that was warm to touch. There is a 3/4 inch circle bruise around one vaccine site. She advised child limped on right leg yesterday and c/o tenderness when first thing in morning. She denied any fever, rash, or other systemic symptoms. Mom gave her TYLENOL for pain with relief. Case 7171.
cold sores; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (cold sores) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ORAL HERPES (cold sores). At the time of the report, ORAL HERPES (cold sores) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Allergic on skin with red and rash for the whole body. PRO included skin pain (NRS  = 3)and itch (NRS = 6). Starting from 1 hour after the vaccine. It lasts for 3 days. I took Benadryl for 3 days, 3 times per day and 50mg each time.
Diarrhea really bad; Bad Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea really bad) and VOMITING (Bad Vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced VOMITING (Bad Vomiting). On 13-Aug-2021 at 3:00 AM, the patient experienced DIARRHOEA (Diarrhea really bad). On 13-Aug-2021, DIARRHOEA (Diarrhea really bad) and VOMITING (Bad Vomiting) had resolved.            No Concomitant medications were reported No treatment medications were reported.
Patient went to both primary doctor and ER with the outcome of Bell's Palsy.  Patient reported tingling/numbness/droping of one side of face following vaccination starting the following day.  Patient was put on a treatment of acyclovir and prednisone.