chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm starting a few hours after vaccination and lasting one day. Slight swelling around vaccination area. Chills starting about 6 hours after vaccination, and lasting about 3 hours. Fatigue during the evening and following morning after vaccination.
This spontaneous report as received from a nurse concerning a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions or allergies were not reported. On 07-OCT-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (multidose vial) (0.5 ml, dose, frequency and route of administration were not reported) (lot # J006921, exp date: 09-AUG-2014 also reported as 08-SEP-2014). No adverse experience was reported. Product quality Complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report has been received from a physician via a company representative and refers to a 15 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2017, the patient was vaccinated with the second dose of GARDASIL 9 dose 0.5 ml (route of administration, lot # and expiration date were not reported). On an unknown date in 2017 (reported as she came back to the office on 05-APR-2017), the patient experienced hives on her face and lips swelling. The treatment was given for the adverse events. No product quality complaint was involved. The outcome of the events was not reported. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
2 in induration of injection site/ redness measuring at 3 inches/ tenderness/ warm to touch.  (ongoing )
experienced severe reations; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
On 8/14/21 patient had weakness and SOB. Came to ER on 8/25/21 with worsening generalized weakness with mild exertional dyspnea. Mildly elevated troponin of 0.082. In the emergency room, patient is saturating okay at 94% on blood work. There was slight elevation on the creatinine from baseline.  Chest x-ray showing pneumonia and CT angio with no pulmonary emboli.  Admitted for COVID-19 pneumonia and acute kidney injury.  For his COVID 19 infection/pneumonia, patient did not require any supplemental oxygen, was not placed on Decadron.  There was not any concern for superimposed bacterial infection.  No fever.  No leukocytosis.  Antibiotics were held off on this admission.  CT angio:  No pulmonary embolism.  Patient remained on room air during the hospital stay and did not desaturate on ambulation. Discharged on 8/27/2021
1) Within 4 hrs of injection #2, highly fatigued, took two hours nap; 2) evening of Day 1, mild headache. Day 2: mild fatigue, no headache, mild lymph node swelling in neck. Night of Day 2: woken from sleep by nasal congestion, moderate airway constriction, wheezing. Cleared by next morning without need for rescue inhaler .  Day 3: continued mild fatigue
7 days after vaccination developed fasiculations in Left deltoid muscle for several hours - enough to keep me awake No other  known reason for these.
Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering.   Information on the lot/batch number for first dose has been requested.
Patient is only 10 years old & our record we have charted 12/4/2021 at 1554 as his first dose &  on 12/27/2021 at 1459 we have this charted as his second dose. However, it appears that Pharmacy gave 2 (Adult doses 0.3ml) doses as well on 7/15/2021 (no LOT number charted) &  8/08/2021 which totals 4 doses. Boosters 1 & 2 are not available for his age group.
I had the vaccine, just a minute now, I started feeling really badly like terribly tired and like I hardly move. The whole thing is complicated because I had oral surgery three days after the vaccine as well. I had extreme pain from that as well, because it is the mouth. I just felt awful beginning the day after the vaccine though, extreme fatigue I've never had in my life. I attributed it to the mouth surgery but my grandson had the same symptoms when he had Covid so it is confusing. I had a virtual DR visit on Friday afternoon 10/01/2021.
Patient reports swollen shoulder months after vaccine. Patient reports needing and doing surgery after the vaccine per her surgeon's recommendation.
Information has been received concerning a 49 year old female who on 12/01/2000 was vaccinated with a second dose of hep b vaccine recombinant at the edge of the deltoid. Concomitant therapy included triamcinolone acetonide. On 02/01/2001, the pt received three injections of triamcinolone acetonide at another office. On 04/02/2001 the pt experienced soreness at the injection site on arm and in denture the size of a quarter at the injection site. Additional info has been requested.
Mother reported underarm swelling and redness. Seen at MD on 5/8/00 for same. Complained of headache at back of head. Advised not to have TD shot again. Swelling of left arm only.
This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD (dose, frequency and route of administration were not reported) with lot number of M007963 and expiration date of 15-AUG-2017, for prophylaxis. No adverse effects were reported. No further information was provided. As of 30-NOV-2016, all telephone attempts to obtain follow up information have been unsuccessful. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA000978: MERCK 1610USA004065:Mfr number.
sz manifested as apnea x 5 days (x 7-8 total) placed on Phenobarbital;
Syncope ~2 minutes after receiving vaccine (VARIVAX).  Pt drowsy & c/o headache ~20 minutes after vaccine.
Immus given 03-16-09.  Called by mom about red hot areas on arm.  Came in for eval.  No resp. problems.  Relaxed and reading book.  R arm (deltoid) red and hot to touch.  Area is 11cc. L arm (deltoid) red & hot.  2.5cm area.  Small bumps at injection site.
ear infection; irritability; received 3 doses of Fluzone Quadrivalent 0.5mL; Initial information received on 31-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's mother).  This case involves an 11 months old male patient who experienced irritability (irritability), ear infection (Ear infection) and reported extra dose administered (extra dose administered), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient received first dose at 9 months.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and IPOL for Immunisation.  On 17-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 21-Nov-2019 he also received a dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 30-Dec-2019 he also received a dose of the same vaccine with an unknown batch number via unknown route in the left thigh.  On an unknown date, the patient developed a non-serious irritability (irritability) and ear infection (ear infection) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient visited on 30-Dec-2019 for follow up for ear infection.  It was also a case of actual medication error due to extra dose administered.  Laboratory data was not reported.  Final diagnosis was irritability.  It was not reported if the patient received a corrective treatment.  The outcome of both the events was unknown at the time of reporting.  Information on the batch number was requested.  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
Had Body Pains,  arm pain at the site of vaccine, and EAR ACHE in both the ears at once lasting more than a day, fever and chills
He started taking  Giferan gel - for acne - it dried out his skin - he started using this a week before the vaccine; on the 31st - rash around his mouth - it was getting red and crusty and looking abnormal - called the Intertrigo- bacterial infection. Put him on antibiotic cream - Mupirocin 2 % ointment. Five day treatment It's resolved now. Dermatologist: dermatology is where we went and he saw a PA.
2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2022 and was forwarded to Moderna on 15-Mar-2022.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) 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 25-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) 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.   Concomitant medication was not reported. Treatment information was not reported.
the evening of the vaccination, I began itchiness, which increased over the next day.  by day two  itchiness increased to uncomfortable levels; the  eyes,  face, neck, ears, chin, lips were swollen;  slightly red or blushed;  no hives or rash. mouth dryness. no response from primary physician on 10/8 and increased symptoms, I went to immediate care at 715-745pm.   * an allergic reaction was confirmed and I was given an hydration drip of three medications:  I think steroid, antihystimien, 3rd items; also prescribed a six  day  dose of METHYLPREDNISOLONE 4MG DOSE PK
Fever and extreme chills 10-15 hours after vaccine. Chills went away, fever, headache, and nausea persisted the day after taking the vaccine. Felt normal 48 hours after taking vaccine.
lightheadedness,dizzy,seeing spots,abd pn, nausea,and Left upper quad pain.  After 2nd dose in July of 07 she experienced all of these plus severe hot flashes, sweats,severe muscle pain and weakness, collapsing and passing out as well as chest pain.  She is now sick on a monthly basis and her sickness usually lasts 7-8 days.  She also becomes delusional at times and spacey.  7/14/2008 MR received from PCP from 5/2/2007 through 7/3/2008. HPV #1 5/2/07. Seen 6/15/07 with c/o several week hx of abdominal pain, nausea and fever. PE WNL. Assessment:  Abdominal pain, nausea of ? etiology. Referred to ER PRN. F/U ER visit 6/24/07. PE (+) for abd tenderness, worse in LUQ and epigastric area. (+) guarding. Assess:  Abd pain NYD ? constipation. 7/30/07 2nd HPV. ER visit for abdominal pain 1/24/08 with Assess:  Abdominal pain, possibly due to medication intolerance, benign exam. Hx sinusitis.  Anxiety componant. Seen 2/28/08 where pt became hot, started crying, c/o body aches, felt like passing out.  BS 89. Seen 3/2/2008 w/ c/o constant back pain which radiates to the chest, feeling dizzy. PE (+) for abd tenderness and tenderness over L chest wall, costochondral joint.  DX:  Abd pain LUQ. ? Splenomegaly.  Chest wall pain.  dizziness. Refered to endocrinology clinic.  Seen for unusual spells with features of power, diaphoresis, visual disturbance, abdominal pain, and vomiting. Witnessed absence spell where pt became pale and unresponsive.  BS 87. Pulse 80.  No clear dx. ? conversion rxn. Seen 6/9/08 with R sided abd pain and feeling faint. PE (+) for abd tenderness, perleche. Assessment syncope. 6/30/08 seen w/ c/o dysuria, recuurent back pain with vasomotor symptoms. Paraspinus muscle spasms noted L2-4. 7/3/08 pain and vomiting persist. .
Felt one supraclavicular lymphadenopathy +-peas sized node same left side as vaccine. Tender, moved around, presents less mobile when neck stretched away/ear to shoulder right side; somewhat tender/sensitive. Will monitor size over next week -6weeks
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 53-year-old, adult male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml (explicitly coded as overdose), route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after administration of the vaccine. This case 201804662 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The event coding for the verbatim 'Received 1.5 ml dose instead of 0.5 ml' was changed form 'Extra dose administered' to 'Overdose'. The narrative and case comment was amended accordingly.
nickel sized purple bruised at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (nickel sized purple bruised at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (nickel sized purple bruised at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (nickel sized purple bruised at the injection site) 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.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Estimated due date: 07/17/2021. I woke up in the middle of the night feeling very hot and sweaty. I woke up later in the morning with a pretty bad headache. Consulted my OB-GYN who said it was ok to take a Tylenol. It helped ease it a little better in the afternoon. Next day when I woke up I was fine.
LATER THAT DAY PT STATES SHE STARTED EXPERIENCING INCREASED SOB, FATIGUE , HEADACHE, AND MENTAL FOG. THE SOB DID RESOLVE AND SHE WAS NOT SEEN IN ED
tested positive for Covid; sick as heck; This is a spontaneous report from a contactable consumer (patient, self-reported). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1686), dose 1 via an unknown route of administration on 25Jan2021 at 11:30 as single dose for covid-19 immunisation. The patient's medical history included COPD (takes 3 inhalers for that), AFib, blood sugar and type 2 diabetes from an unknown date. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) started taking about a year ago, tiotropium bromide (SPIRIVA) started taking about 7 months ago and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) started taking about 7months ago for chronic obstructive pulmonary disease; apixaban (ELIQUIS) started taking 6 months ago and diltiazem hydrochloride (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]) started taking 6 months ago for atrial fibrillation; metformin started taking 7 years ago for type 2 diabetes mellitus and saxagliptin started taking 7 years ago for blood glucose abnormal. On 27Jan2021, 2 days after the vaccination, the patient had sick as heck. On 29Jan2021, the patient tested positive for COVID-19 and the patient went to ER and had a bad symptom, tested positive. The patient goes to the clinic and once every 3-4 months they change doctors and contacted by the health department and got all his information. Patient had symptoms for 2 days and just kept getting worse so went to the ER. He was not admitted to the hospital. The patient state that about 4-5 days later his wife got COVID-19 and must have got from him he guesses, and he got the shot and there must have been someone in there that had it and he must have got in contact with them but he's not sure how because everyone was wearing masks. Also stated that it just happened, and he was still heavy in the COVID-19 then and he missed the dose. He enquired that he had 1 dose and missed the 2nd dose, the patient had COVID-19 and probably have antibodies, what does he need to do, and does he need to start over or does he need to get the second dose at all. The patient was supposed to take second shot on 15Feb2021. The patient had probably beginning, pretty rough no need for the hospital, but stayed home with medication, some rally offensive antibiotics, that stayed in my system for 15 days. I got better. but it was in the middle of the series. I think maybe I got it in line for the vaccine. All events are non-serious. The patient underwent lab tests and procedures which includedCOVID-19 SARS-Cov-2 test was positive on 29Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Fever 103 degrees; Rigors; Severe body aches/Muscle pain; Severe body aches/Muscle pain; Fatigue; Nausea; Anorexia; Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease, fibromyalgia, migraines, paroxysmal atrial fibrillation, gastroesophageal reflux disease (GERD), hypercholesterolemia, anemia of chronic disease, cerebrovascular accident (CVA) and brain aneurysm. The patient had no known drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (PRILOSEC), famotidine (PEPCID), aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA), progesterone (PROMETRIUM) and estradiol (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. On 17Apr2021 at 04:00, the patient experienced fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, 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 fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/05/2021 and 02/11/2021. They tested positive for COVID-19 via antigen test twice on 10/06/2021, at the skilled nursing facility at which they were a resident. It is not known if the individual had a specific symptom onset date as they had several underlying medical conditions that can cause similar symptoms. The individual died on 10/11/2021. It seems they were not hospitalized related to this illness.