chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose > 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days ago) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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(s). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication information was reported.
Developed head and body aches, strong malaise, and brain fog, all more severe than what I had experienced with the actual disease.  Unlike during the disease, my hips strongly ached 24 hours after recieving the injection.  COVID cough returned though not as bad as when I had the disease, as well as fealing weak and out of breath.  All of this lasted for about 36 hours.  Feeling a bit better now, but still winded and weak.   Still plan to get 2nd shot.
Fatigue, Headache, Muscle/Body Aches. Headache lasted for a week.
exhaustion; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (exhaustion) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (exhaustion). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and FATIGUE (exhaustion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: updated PO BOX
Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Right leg pain followed by Stroke April 6, 2021 After stroke: Hospital for three weeks followed by twelve weeks of extensive occupational and speech therapy
Information has been received from a licensed visiting nurse concerning a patient who on 17-MAY-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot3653284/0002F), intramuscularly.  Subsequently, the patient experienced cellulitis.  Unspecified medical attention was sought.  The patient recovered.  Additional information has been requested.
pt recvd vax 15JUN94 & approx 2 cm diameter firmness @ inject site rt leg no other signs & sx of adverse react; no treatment given;
Arm sore for 2 weeks Rash appeared 2 weeks after vaccine Upper arm is red, blotchy and warm to touch
The pt developed febrile seizure with in 12-18 hrs post vaccination. Went to ER and was considered fine.
This spontaneous report as received from a health care worker refers to multiple unspecified patients with unknown demographics. No medical history was reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with a dose of an improperly stored oral, ROTATEQ, (dose, route and frequency: unknown, lot number: L002042, expiry date: 28-JUL-2016). No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Day after vaccine - fever 100.5 to 101.8, fatigue, stuffy nose, headache, chills, body aches
I did not have a period for two months, followed by 22 days of bleeding, then two months of no bleeding again or any menstruating.
Patient was vaccinated twice in 2 months by accident. He is fine but received 2 doses.
Was hospitalized for 5 days after second dose, dizziness, struggling to walk, heart rate very high, cold sweats, felt like I was going to faint. Went to neurologist, given anti-anxiety medicines and medicine for dizziness. Ended up being too strong of sedatives, did not work well
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE. STABLE ANGINA; ANGINA, UNSPECIFIED.
Thrombocytopenia, with platelet count of 17,000, developed on Dec. 7.  Patient had received vaccines on Dec. 6. 12/14/06 Received medical records from provider which reveal hospital labs of 12/8/06 with platelets of 17,000, segs 46, lymphs 40 compatible with ITP. 1/2/07 Received hospital medical records which reveal patient admitted 12/8/06 with spontaneous bruising & petechiae.  Improved & d/c to home 12/10 w/heme f/u.  No d/c summary available. HPI: diarrhea several days prior to admission, bruising/petechiae 1 day prior to admission on forehead, neck, arms, legs abdomen & buttocks.  Patient had been seen by PCP 2 days prior to admit for well child vs & given vax.  Took back to PCP & CBC revealed WBC of 8.72, plts 17,000, 46 % segs, 1% bands, 40% lymphs, 6% monos, 1% eos. ADMIT DX: probable ITP idiopathic thrombocytopenic purpura.
4 hours after vaccine: inconsolable crying for 30-40 minutes (hard to catch his breath). 2 inch circumference red area surrounding site times 30-40 minutes with above.
Severe leg pain and swelling fever over 104.5 extremely cranky fussy lethargic.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates in 2015, starting on or after 28-OCT-2015, an unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (route of administration and dose number were not reported, lot number: L013429 and expiry date: 21-JUL-2017). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
For the first two doses I had a sore arm, which I expected; 1st dose administration date 16Jun2021 2nd dose administration date 11Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 14:00 (Lot number: FE3380) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; FLUOXETINE. Vaccination history included: Bnt162b2 (prev dose administration time=08:45, AM, prev dose dose number=1,, prev dose vaccine location=Left, arm, prev dose lot number=FA1027), administration date: 16Jun2021, when the patient was 28 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Aug2021 14:00, outcome "unknown", described as "1st dose administration date 16Jun2021 2nd dose administration date 11Aug2021"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "For the first two doses I had a sore arm, which I expected". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Lamotrigine, Fluoxetine, Birth control. For the first two doses she had a sore arm, which she expected. However about 16 hours after her booster she also had chest pain and heart palpitations, which I have never had from a vaccine before.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse referring to a 12 year old female patient who was allergic to CECLOR and CEFZIL. On 18-AUG-2016 the patient was vaccinated with the second dose of VARIVAX (lot # M005973, exp date subcutaneously in the left arm. Concomitant therapies included MENACTRA and TDAP. There was no illness at time of vaccination. According to nurse's note, on 18-AUG-2016 (also reported as 16-AUG-2016) approximately 10 minutes after shots, the patient's left upper arm from top on shoulder down below, 2 inches about elbow was red and warm to touch. No severe drug-induced anaphylaxis (SDA) or difficulty breathes was reported and it was not observed on trunk or back. 0.5 ml BENADRYL was given orally to the patient and after the BENADRYL, the patient resolved on the same day. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23, (dose number, frequency, route, anatomical location, lot number and expiration date were not reported), for prophylaxis. On 19-DEC-2016 the vaccines experienced a temperature excursion of 29.8 Fahrenheit Degrees for 30 minutes, and, on 03-APR-2017 experienced a temperature excursion of 49 Fahrenheit Degrees for 15 minutes. The digital data logger was involved. No side effects were reported by the reporter. Concomitant therapies included sterile diluent, however, the registered nurse did not provide any lot number or expiration date for the properly stored sterile diluent. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA011906: US-009507513-1704USA012149: US-009507513-1704USA012147:
Information has been received from a physician concerning a adolescent female who was vaccinated intramuscularly with a 0.5ml dose of GARDASIL (lot # not reported). The patient fainted after receiving the vaccine. After she recovered. She stayed at the office for 15 minutes, as she was checking out she fainted again. Outcome was unknown. Additional information has been requested.
Tinnitus in both ears, worse in the left ear. The condition began as a periodic whooshing sound in one ear that lasted for a day or two, after which it became a constant ringing in both ears. I have not had tinnitus previously. Prior to the condition, I was not exposed to any loud sounds. I work from home at a desk in a quiet room and have done so for years.
Stayed in bed all day; Fever; Felt terrible; Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021; Feel Achy/Muscle Aches; Slight Headache; Feeling "run down"; Red, round circle at injection site; Stomach problems/stomach was upset; Feels like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), VACCINATION COMPLICATION (Stayed in bed all day), FEELING ABNORMAL (Felt terrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver cirrhosis (non-alcoholic liver cirrhosis) and Diabetes.    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021), MYALGIA (Feel Achy/Muscle Aches), HEADACHE (Slight Headache), FATIGUE (Feeling "run down") and VACCINATION SITE ERYTHEMA (Red, round circle at injection site). On 29-Aug-2021, the patient experienced FEELING ABNORMAL (Felt terrible). On an unknown date, the patient experienced VACCINATION COMPLICATION (Stayed in bed all day) and PYREXIA (Fever). The patient was treated with PROMETHAZINE for Stomach upset, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), VACCINATION COMPLICATION (Stayed in bed all day), FEELING ABNORMAL (Felt terrible), MYALGIA (Feel Achy/Muscle Aches), HEADACHE (Slight Headache), FATIGUE (Feeling "run down") and VACCINATION SITE ERYTHEMA (Red, round circle at injection site) outcome was unknown and PYREXIA (Fever) had resolved.            No concomitant medications were reported. The patient feels slightly better.   This case was linked to MOD-2021-301037 (Patient Link).
Fever, about 3 degrees above normal temperature. First aware of it about 28 hours after receiving the vaccination.  Fever lasted approximately 25-26 hours.
Breakthrough COVID-19 case with symptom onset 8/28/2021: Runny Nose/Congestion, Shortness of breath/difficulty breathing, Fatigue or tiredness, Cough. Patient states he was admitted to hospital for close monitoring on 09/03 due to his COPD and emphysema. Discharged 9/5/2021.
11/15/02 09:45 AM: Client called in with c/o nausea + hot flashes, Stated she "just did not feel good". 11:00 AM: Did leave work early + went to her mom's house because client was not feeling well + did not want to drive home to Nassau, States went home later that evening + was feeling somewhat better, 11/15/02: States is doing fine now
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into data tracking prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and lot tracking reconciliation o Training on how to enter information into data tracker when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Patient received booster dose of Pfizer vaccine, even though patient is under 18 years of age. Patient received second dose of Pfizer vaccine over 6 months ago (May 2021). No immediate adverse signs of symptoms of vaccination. Patient and family were notified, and instructed to return to clinic if concerning symptoms began.
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-APR-2017, the patient inadvertently received an expired dose of ZOSTAVAX (route of administration was not provided) lot # L028279, expiration date: 28-OCT-2016.  The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot# and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.
HPV vaccine, Tdap, meningococcal vaccine given in that order Patient abruptly became short of breath with pallor 0.3 mg EpiPen administered Symptoms abruptly improved Posttreatment side effects included shivering otherwise tolerated administration well
12-19AUG screaming constant leg, couldn't move body or cry; 19-30AUG still alot of crying when awoke; excessive sleeping; pt would wake up stiffen body for 30-40seconds then go back to sleep 29th of Aug 102 fever, rash, crying & very limp;
This case was reported by a pharmacist and described the occurrence of injection site pain in a 61-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included renal failure (cause not specified) requiring hemodialysis, gastroesophageal reflux disease, hyperlipidemia and pancreatitis.  Concurrent medications included Levothroid, unspecified "renal capsules" and omeprazole.  Previous and/or concurrent vaccination included Engerix B (GlaxoSmithKline) given on 21 May 2007.  On 25 May 2007, 4 days after the subject received the first vaccination with Engerix B, the subject received the second dose of Engerix B (40 mcg, unknown arm) and experienced inappropriate schedule of drug administration.  On 23 October 2007, the subject received the third dose of Engerix B (40 mcg, unknown arm) and experienced injection site pain.  Medical attention was not required.  The vaccination series was delayed.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Engerix B.
redness, pain, itchy, heat in arm where injection was given, headache body aches all over
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 79 year old male patient There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider. On or about 20-FEB-2017, the patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 25-OCT-2013 the patients were vaccinated with ROTATEQ lot number J002505. Dose, route and frequency were not provided. On 25-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
inadvertently administer  the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 048B21A and 018B21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. It was unknown that the patient had COVID positive  test or diagnosis. Patient had no history  relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was unknown that other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. It was unknown that the AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was unknown that the patient experienced a similar event in the past It was unknown that the symptoms improved or worsened  It was reported that HCP had inadvertently administered the vaccine eleven days after expiration date. Vial was initially stored in refrigerator on 27-May-2022 and the vial had not undergone any temperature excursion issue.  No treatment drug information was provided