chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 7-MAY-2021.  No treatment details provided. No concomitant medications reported.
I had fever, chills, sweats, body and joint aches. I developed a rash on both sides of my body on my torso. I seen my PCP and prescribed steroids' for the rash. The fever, chills, sweats lasted about 48 hours. The rash lasted about 11-12 days.
Pharmasist reports that a nurse friend of hers completed 4 doses of oral typhoid vaccine unknown brand name one month ago in May. Mouth has been dry, painful for past month. Pt describes tongue fissures, taste buds on tip of tongue inflammed.  Is currently experiencing symptoms.  Has not seen doctor.
Flu like symptoms; headache; neck and body ache; radiating pain; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; severe genital herpes outbreak; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; This is a spontaneous report from a contactable other hcp (patient). A 56-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, in left arm on 11Feb2021 at 19:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included genital herpes from an unknown date and unknown if ongoing and hiv infection from an unknown date and unknown if ongoing. The patient was allergic to heparin. The concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. After the vaccination, the patient had been tested with covid-19. The patient reported that after first dose he experienced Flu like symptoms for 1-2 days including headache, neck and body ache, radiating pain and swelling into my left shoulder arm and hand with joint pain and swelling in left hand. Then for the next 2 and more weeks, severe genital herpes outbreak (no outbreaks in prior 2 years). The patient underwent lab tests and procedures which included Nasal swab: negative on 08Jan2021. Therapeutic measures were taken as a result of severe genital herpes outbreak that included Valtrex medication for herpes outbreak. The patient recovered from the events on an unknown date .  No follow-up attempts are possible. No further information is expected.
reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes/product storage error temperature too low (with no reported adverse event); adult patients who were administered Fluzone QIV after the temperature excursion with no adverse event; Initial information received  on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA057733(CLUSTER).  This case involves Adult and unknown gender patient who experienced that the Influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes/product storage error temperature too low (with no reported adverse event) and were administered fluzone qiv after the temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received the Influenza quadrival A-B vaccine which reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes/product storage error temperature too low (with no reported adverse event) (product storage error) and received it after the temperature excursion with no adverse event (poor quality product administered) and with form: Suspension for injection (Lot Number:UT7683NA,Expiration Date :2023-06-30 and Lot Number:UT7682JA,Expiration Date :2023-06-30) via unknown route with unknown strength, frequency, anatomical location for immunization.  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Report received from a health professional on 14-SEP-2010. This case was original reported to Merck (WAES number: 1009USA03335). A 64 year old male patient received 0.5ml of AFLURIA (batch 09949121B, expiry 15-JUN-2011) via intramuscular route in the left deltoid on 11-SEP-2010 for the prevention of flu. The patient's medical conditions included atrial fibrillation and diabetes. Concomitant medications were unknown. The patient has an allergy to morphine. On 11-SEP-2010, the day of receiving the suspect drug, the patient went home and felt funny and then had increased heart rate. The patient has had unspecified flu shots in the past and was ok. The patient sought medical attention from the pharmacist and the physician. The event outcome was unknown. The company considered this case to be not serious. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Erythema, edema, rash and pain (10x12 cm), arm pain
Dizziness, tightness in head. Patient states that  symptoms eased after 10m  minutes. She ate some pretzels.
Significant bone pain, primarily affecting hips and cervical spine. Self treated with some effect with OTC pain relievers, but mild discomfort still present.
2 inch diameter raised red rash 2 inches below vaccine injection site left arm deltoid area. Itches a lot. Painful to touch/pressure. Skin is what is painful, not the muscle.
Injection site redness, itchiness, and swelling. Began within an hour of injection and started to spread towards elbow AND shoulder only. No other symptoms or sites affected. Sx resolved with cold water bath per patient.
sore right injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site shoulder). At the time of the report, VACCINATION SITE PAIN (sore right injection site shoulder) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient received her vaccine in the right arm shoulder deltoid muscle.   This case was linked to MOD-2021-289814 (Patient Link).
A few days after PREVNAR injection (patient is not sure of exact timeframe), patient showed signs of redness, inflammation, and pain on upper left arm below injection site. Patient made an office visit 8/23/17 with primary and MD diagnosed her with cellulitis as a result of the vaccine. She was prescribed an antibiotic.
Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Non-Significant follow up appended-Email ID updated
Patient was coming from her OB office to receive 1 dose of tdap, indication is she is pregnant. During draw up of vaccine, incorrect vaccine was pulled from stock. Dtap vaccine was administered to patient. Patient is currently 27 weeks pregnant. The patient and provider were notified of error made. Provider spoke with the patient about a reaction and any questions they had. Per standing orders Tdap does not need to be administered if Dtap was given.
Bump in arm; Big red whelp; mild ache in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bump in arm), RASH (Big red whelp) and ARTHRALGIA (mild ache in shoulder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced ARTHRALGIA (mild ache in shoulder). On 16-Aug-2021, the patient experienced PERIPHERAL SWELLING (Bump in arm) and RASH (Big red whelp). At the time of the report, PERIPHERAL SWELLING (Bump in arm), RASH (Big red whelp) and ARTHRALGIA (mild ache in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-329763 (Patient Link).
he got covid after it; he got covid after it; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer or other non-health care professional (patient's wife) reported for male patient (reporter's husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had vaccine but got covid after it. On an unspecified date the patient underwent lab tests and procedures which included Covid-19 positive.  Information on the batch/lot number has been requested. Additional information is expected
Red rash measuring 1.5" dia at injection site. Tender, non-itchy
Nausea; vomiting; fatigue; body-wide muscle aches; fever 99.1 deg. F; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins nos (MANUFACTURER UNKNOWN), melatonin supplement (MANUFACTURER UNKNOWN), paracetamol (ACETAMINOPHEN) and unspecified OTC medications from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 the patient experienced nausea, vomiting, fatigue, body-wide muscle aches and fever 99.1-degree fahrenheit. The events did not result in a doctor or other health care professional office/clinic visit, and the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, fatigue, body-wide muscle aches and fever 99.1-degree Fahrenheit was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Patient claims injection site was too high on the shoulder, and vaccine most likely went into the shoulder capsule. Complains of sore arm, no other symptoms.
it has only been 19 days between the first and the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has only been 19 days between the first and the second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has only been 19 days between the first and the second dose). On 31-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has only been 19 days between the first and the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up updated reporter information, patient information, dose 2 information added.
I had nothing until that point - I was taking a shower and saw redness on arm. It was warm; it didn't really hurt. I called the doctor and they asked me to come in to make sure it wasn't an injection site infection. They told me to take Benadryl and it cleared up in a day and a half. They said it was an injection site reaction.
Shingrix series complete, get shingles rash a few months later/ suspected vaccination failure; Shingles rash; Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: Pharmacist states that he sometimes had patients who completed Shingrix series and then get shingles rash a few months later. The pharmacist did not have any patient specific information at time of reporting, just states that it had happened to several patients. The reporter consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting. This case had been linked with US2022AMR125956, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR125956:Same reporter
soreness in arm; didn't have much energy; sleepy; experienced jaw pain on his left side/more jaw pain; teeth were sensitive to cold; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in arm), ASTHENIA (didn't have much energy), SOMNOLENCE (sleepy), PAIN IN JAW (experienced jaw pain on his left side/more jaw pain) and HYPERAESTHESIA TEETH (teeth were sensitive to cold) in a male patient of an unknown age 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 MYALGIA (soreness in arm), ASTHENIA (didn't have much energy), SOMNOLENCE (sleepy), PAIN IN JAW (experienced jaw pain on his left side/more jaw pain) and HYPERAESTHESIA TEETH (teeth were sensitive to cold). At the time of the report, MYALGIA (soreness in arm), ASTHENIA (didn't have much energy), SOMNOLENCE (sleepy), PAIN IN JAW (experienced jaw pain on his left side/more jaw pain) and HYPERAESTHESIA TEETH (teeth were sensitive to cold) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
A patient (demographics were unknown) had received a dose of FLUZONE High-dose (lot number, dose in series, route and site of administration were unknown) on an unspecified date last Fall. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination were unknown. Concomitant medications were not reported. On an unspecified date, after vaccination, the patient had a reaction (not specified). Laboratory tests and corrective treatment were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender were none.
Early morning of 5/29/2021, I experienced chills, fever, fatigue. Chills and fever resolved after about 6 hours. Fatigue lasted about 48 hours.  Since then, and still continuing as of the time of this report (6/11/2021), I am experiencing periodic chest tightness that comes and goes. It  often, but not always, increases with physical exertion, but it sometimes is experienced even at rest.  On 6/10/2021, I had a tele-medicine consultation with a doctor who prescribed 600mg ibuprofen 3 times daily for one week to try to resolve suspected myocarditis resulting from the vaccine.
About 15 seconds S/P FLUZONE 0.5ml IM;  Dyspnea, tongue swelling, tinnitus.  50 mg BENADRYL IM and 0.3 ml EPINEPHRINE SQ given - Transported stable condition to ER
It was reported that a 70 year old female received Fluzone SV '99-'00 vaccination on 10/6/99. On 10/8/99, the pt experienced a "local reaction of redness, swelling and soreness". No further information is available at this time. From correspondence received on 5/2/00, it was reported that the pt recovered from this experience. No further information available regarding this pt or this case. This case is closed.
Large 5in diameter round, raised, hot, swollen area at injection site. Headache and felt dizzy. He was given steroids, BENADRYL and MOTRIN by urgent care clinic around 36 hours after injection given.
Approx 45 minutes after vaccine, throat swelling that started to decrease after about 3 hours. Mild swelling, no wheezing noted, but noticeable when swallowing and eating.  The next day, approx 12 hours later, supraclavicular lymph node enlargement, pain, and  tenderness on left side (the side of vaccine). Tenderness and swelling lasted approx  1.5-2 weeks, gradually decreasing.  Reported results to online site that checks in on pt after COVID 19 vaccine, symptoms checker
My left arm where I had a COVID-19 shot started swelling with redness and itchiness 2 days ago. Redness/swelling is about 11cm. Symptoms started a week after the shot was given and it seems like the redness/swelling is getting worse since it started 2 days ago.
Patient had a vasovagal episode following administration. Per - Pt stated that he faints during vaccines or anything of the sort. Patient fainted. Patient regained consciousness after about 2 mins.  PA assisted PT  with patient observation. Patient was observed for 30 minutes until stabilized.
30Jan91 put down for nap "jumped, choked & gasping for breath"- con't gagging, FM call 911 but when they got there baby was fine. Saw PMD 15Feb91 but he does not feel it was realted to immun.
Patient was too young to receive Janssen vaccine, but received it by mistake We need to be more diligent about asking date of birth. We have staff who are contractors who should review papers before sending patients to the vaccinator. We need to double check before vaccinating.
The patient developed quick onset of generalized weakness and nonproductive cough.  She was admitted to the critical care unit from the Emergency Department and was positive for COVID-19, right upper lobe pneumonia, septic shock, and COPD exacerbation.  She received her most recent chemotherapy treatment for lymphoma about one week prior to admission.  She received treatment for pneumonia with vancomycin and meropenem, remdesivir, dexamethasone, albuterol, and pressor support with norepinphrine. As of May 19th, she has improved significantly, but still remains in the critical care unit.
Pt recvd vax & 30 mins p/inject exp hives & itching rash generalized over body;