chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022; Patient received dose after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2022 at 11:51 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-May-2022 at 11:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after the beyond use date) and PRODUCT STORAGE ERROR (Vial intially stored on 31-Jan-2022 and thaw expired on 02-Mar-2022) 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 affected Lot 045L21A was initially stored on 31-Jan-2022 and the thaw expired on 02-Mar-2022. Total doses administered was reported as 20 doses and number of vials used was 15. The vial did not undergo any temperature excursion.  Treatment medications were not reported.   This case was linked to MOD-2022-583132 (Patient Link).
Report fever, chills, abdominal pain 24 hours post vaccination that resolved within two days. Headache- intermittent started before receiving the vaccine, but continued after receiving the vaccine. Outcome: Symptoms has resolved and over all feels much better.
sore arm at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included WARFARIN from 11-Feb-2021 to an unknown date for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (sore arm at the injection site). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.
She got her vaccine, the minute it went in it stung.  The next day she had pain in her left armpit, which she did not have with the 1st 2.  Then she had tiredness, slight headache, but that went away in a couple of days.  The stinging armpit area is bothering her, it is always there and when she sweats it is worse and uses cold compresses to calm it down.  Everything in that area felt swollen, including her breasts.  She called her doctor and cannot go see him until she gets new insurance in place.
BODY ACHE; STUFFY NOSE; SORE THROAT; HEADACHE; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) .5 ml, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced sore throat. On 13-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced body ache, and stuffy nose. Laboratory data (dates unspecified) included: Fever (NR: not provided) 102 F, 101.3 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, headache, sore arm, and sore throat, and the outcome of body ache and stuffy nose was not reported. This report was non-serious.
Approximately 4 - 5 hours after taking the vaccine, fever, intense muscle pain, pain at the point of vaccination, joint pain, nausea and difficulty sleeping the first night.
Headache, Arthralgia, chills, injection site pain and swelling Narrative:
Sense of smell is off, smells like old cigarette smoke.; Can still smell, but not as strong as before; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history include hypothyroidism. The patient had allergies to sulpha antibiotics. Prior to the vaccination, the patient had tested positive for COVID antibodies. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included WP THYROID. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 14.00, the patients sense of smell was off and smelled like old cigarette smoke (altered smell sensation). The patient could still smell but not as strongly (diminished sense of smell) as prior to the vaccine. It was reported that the patient had COVID 3 months ago but sense of smell had fully returned. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events diminished sense of smell and altered smell sensation were not resolved at the time of this report.  No follow-up attempts are needed. No further information expected.
(1) Severe headache and swelling RT arm - Aspirin TYLENOL. Ice pack initially. (2) Repetition of above q 2 weeks with shooting pains RT side body to left side of body. Pain in chest and up L back. Headaches with vision changes and low grade fever.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 immunisation.     No Medical History information was reported.   On 27-Feb-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:15 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Mar-2021 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 57.95 years.  Concomitant products were not provided.  On 27-Mar-2021, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR, route of administration and date unspecified, as single dose. Medical history and concomitant medications were not reported. The patient experienced pneumococcal pneumonia on an unspecified date with outcome of unknown.
sore throat; diarrhea; no appetite; fatigue; back of my head was aching really bad; fever of 100°F; like the wind was knocked out of me, short of breath; feet were burning like I had neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (like the wind was knocked out of me, short of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (like the wind was knocked out of me, short of breath) (seriousness criterion medically significant), BURNING SENSATION (feet were burning like I had neuropathy), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100°F). On 23-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite) and FATIGUE (fatigue). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; LEVALBUTEROL [LEVOSALBUTAMOL] at an unspecified dose and frequency and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at a dose of 2x daily. At the time of the report, DYSPNOEA (like the wind was knocked out of me, short of breath), BURNING SENSATION (feet were burning like I had neuropathy), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100°F) had resolved.            Concomitant drugs was not provided. Treatment drugs included increased nebulizer, valeramide, Chromalin.  Patient lied down and slept for 4 hours.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.
pt recv vax 9JUN97, 16JUL97, 15JUN97 & again1AUG97 & pt exp joint pain & fever intermittently every two to three days over two weeks;
At about 2:00 PM, I began to feel dizzy and hot and was sweating. At 7:00 PM, I experienced sever abdominal cramping, and pain with subsequent waves of diarrhea for approximately the next eight hours.
I was positive for COVID-19 on 21MAR2023, I had a fever, a lot of fatigue and I was lethargic. I was coughing and dry , I did lose my sense of smell for about 5 days. My sleep was abrupted, I had chills and night sweats. I had occasional hives on my skin in sports where it was red and itchy.
Swelling and soreness in entire upper arm-right. Large red area 5 to 6 inches below injection site wrapping 1/2 way around the arm and it is hot to the touch. Joint, bone & muscle pain similar to flu symptom. Shivering chills and extreme tiredness.
Advance - I told the intake/paperwork personnel that I was taking topomirate (Topomax), in case the  blood thinning "qualities" were or would become a factor during or after the vaccination(s). They left the table and retrieve a HOT PINK covid Vaccination Record Card for me.
given injection DTaP left deltoid on 04/27/2005. 2 Days later 04/29/05, pt presents with left upper arm, redness, 5x7cm size, warmth to touch to site, non painful. Per mom redness started 7AM of 04/28.
Information has been received from a registered pharmacist concerning a female patient with allergies to Penicillin ("ACETOPHIN"), and ("QUINOLONE") and on unspecified therapy for brain cancer, who was vaccinated with a dose of Pneumovax 23. Concomitant therapy included alendronate sodium, cough, cold, and flu therapies (unspecified), and antimicrobial (unspecified). The patient received two doses of the vaccine within 3 months time. Subsequently, the patient experienced flu-like symptoms of headache, chills, and fever. Unspecified medical attention was sought. No diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Recurring daily fevers for 3 months post vaccine.; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Recurring daily fevers for 3 months post vaccine.) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Recurring daily fevers for 3 months post vaccine.). At the time of the report, PYREXIA (Recurring daily fevers for 3 months post vaccine.) outcome was unknown.        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.   No concomitant Medications were Reported. No treatments were Reported.
Red, warm to touch, swelling, itching at injection site 1 week post administration.
possible hearing loss; swollen ears; tingling in arms; diarrhea; vomiting; nausea; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). This female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen ears, tingling in arms, diarrhea, vomiting, possible hearing loss and nausea. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Right lateral arm with redness/ swelling/ pain/ warmth. Dx: right arm cellulitis. Rx: with Rocephin (6/16/04)
Itchy/burning papular rash over buttocks and thighs starting few hours after vaccine and peaking 24 hours later, responded to topical triamcinolone and oral levocetirizine
It appears that the patient may of received 2 booster doses about 18 days apart instead of 4 months.
Migraine, swollen arm, hard knot in injection site, redness and fever in injection site, states feels crummy.
developed Atrial flutter, Atrial Afib. My heart rate was very irregular and fast.   It was determined I needed a heart rate monitor inserted in my chest and an appointment for a cardiac ablation at the hospital was set. Within two weeks of the ablation, my heart rate had calmed down and appears to be normal now. I now must take Eliquis and Metoprolol and irbesartan. I never needed these drugs before.
Received a Johnson and Johnson vaccine 7/16/21 without issue. Received the Moderna vaccine booster dose 2/2/22 and within 4 day developed acute encephalopathy requiring intubation and lumbar puncture, embolic stroke in the right frontal gyrus and right frontal centrum, acute onsetn distal lower extremity numbness and weakness consistent with a peripheral neuropathy, rhabdomyolysis, acute kidney injury, and a bullous rash of the palms and soles.
The patient was supposed to receive imovax on (day 0, 3, 7, and 14) but only came to receive vaccine (on days 0, 7, and 10), no AE; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist. This case involves male patient (age unspecified) who was supposed to receive RABIES (HDC) VACCINE [IMOVAX RABIES] on (day 0, 3, 7, and 14) but only came to receive vaccine (on day 0, 7, and 10) (inappropriate schedule of product administration).  The medical history included animal bite (bitten by pit bull).  The past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 01-Aug-2020, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunisation.   On 07-Aug-2020, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunisation.   On 10-Aug-2020, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunisation.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered.  It was reported that the patient was having a complete deviation of schedule of Imovax for a post exposure and was previously unvaccinated. He was ordered to receive Imovax on day: 0, 3, 7, and 14 but only came in on day 0, 7, and 10. The prescriber was following a 4 days dosing schedule.  At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Left submandibular lymphadenitis and left mandibular facial cellulitis.    Started on oral penicillin in the ED for presumes tooth abscess.  No tooth abscess noted in office and was started on clindamycin three times a day for 10 days.
11/14/2009 Hospital ED. Child wheezing. Seen, treated, released.
Did not get the full dose due to a faulty needle; Did not get the full dose due to a faulty needle; A spontaneous report was received from a pharmacist concerning a 35-year old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the full dose due to faulty needle.  The patient's medical history was not provided. Concomitant product use was not reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 19 Jan 2021, during vaccine administration, the patient did not get the full dose due to a faulty needle. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, did not receive the full dose due to faulty needle, was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 35 year old male patient received their first of two planned doses of mRNA-1273 (Lot Number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and did not receive the full dose due to faulty needle. There were no reported adverse events after the vaccine was administered in this case of the patient did not get the full dose due to a faulty needle.
Awoke on 10/16/11 with redness & pain on left side bra area and going around her back. Says blisters appeared on Monday 10/17/11. Dx with Shingles by telephone.
Rec'd flu and pneumonia shot on 9/28/09. In PM had increased pain and swelling in L arm flu shot given (double in size down to wrist). L side neck swollen & SOB. Called ER - took BENADRYL. Called doc and PCP. Hx anaphylaxis in past form medicine.
Third dose given too early on 1/19/22. Language barrier and confusion from pt and guardians. Patient had two doses already and did not need a third o one. Guardian stated it was there first dose and that the patient did not have any doses yet.  1st dose given  9/28/21 and 2nd dose given on 12/3/21.
Immediately following administration of Hep B vaccine, employee passed out, briefly. Monitored and allowed to rest. Resolution of signs and symptoms within 10 minutes. Also reports no po intake prior to vaccinations. No further medical attention received and no further problems reported.
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported. No treatment was reported.   This case was linked to MOD-2021-338604 (Patient Link).
Thursday morning at 5:00 started having chills, started running a fever 101 to 102 all day, arm was swollen and real red, shoulder and neck pain, started sneezing, and eyes were watering, had weakness in legs,  Friday the fever  remained in the 90s. As of today, 01/25/2021 no fever, just arm pain and swelling and red. have taken some Ibuprofen every four hours
10 am arm pain at site, 12 noon severe arm pain, 3pm dizziness joint pain weakness, 7pm chills fever (101) headache body pain weakness
2:50 pm Lips tingling, itchy throat - given 25 BENADRYL. 7:00 pm hives on left arm (area where flu shot was given) hives on stomach, itchy eyes, face, neck - BENADRYL and OTC anti itch cream.