chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender with no pertinent medical history, drug allergies or reactions reported. On 16-OCT-2013, the patient was vaccinated with the first dose of GARDASIL lot # H021608, expiration date: 13-AUG-2015, 0.5 ml, intramuscular. On 14-MAY-2015, the patient was vaccinated with the second dose of GARDASIL lot # K010574, expiration date: 08-APR-2017, 0.5 ml, intramuscular. Concomitant therapy was not reported. It was reported that the patient received GARDASIL outside of prescribing information. No adverse effects were noted. Additional information has been requested.
Left leg 3" diameter with red splotches with hard knot, ran fever at 103.5F. Tylenol administered. No fever this AM (8/8/03). Mother stated now pink and decreasing in size.
congested; aches and pains; fever,highest 99.9; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested), PAIN (aches and pains), PYREXIA (fever,highest 99.9) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 0Z4M20A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congested), PAIN (aches and pains), PYREXIA (fever,highest 99.9) and CHILLS (chills). At the time of the report, NASAL CONGESTION (congested), PAIN (aches and pains) and CHILLS (chills) outcome was unknown and PYREXIA (fever,highest 99.9) had not 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.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-DEC-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient was administered Peds Pfizer COVID Vaccine for age 5-11 on 8/8/23 that had expired 8/1/23 per the 10 week "out of freezing" expiration date.  No patient adverse events documented.
Patient was anxious receiving vaccine.  About 15 minutes after she stated she felt like she had mucus and needed to clear her throat or something was blocking her throat.  She was not experiencing any other signs of anaphylaxis, so a 50 mg dose of Benadryl was given.  She remained in the pharmacy for about 10 more minutes (total time about 25-30 minutes) and went home since no other symptoms were experienced. Patient felt like maybe she just made herself paranoid.
Patient came to ED with vomiting and diarrhea and was admitted with Covid pneumonia.
Information was received from a NP, post vaccine's pt developed and increased temperature and sore throat, runny nose, a rash that itched on her trunk and a few lesions on her arm. The pt did have some sinus congestion. F/U updated pt dob,date of vaccine, date of report,lot # for TD, pt name
SIDE EFFECTS FROM THE VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On OCT-2021, the patient experienced side effects from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects from the vaccine was not reported. This report was non-serious.
Fairly large red spot - 5 inch rectangular area in upper left arm; Ring around red spot - left arm, rim around it and the inside part is fading; Itching at the vaccination site - left arm; Bit of pain at the vaccination site; Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Fairly large red spot - 5 inch rectangular area in upper left arm), RASH (Ring around red spot - left arm, rim around it and the inside part is fading), VACCINATION SITE PRURITUS (Itching at the vaccination site - left arm), VACCINATION SITE PAIN (Bit of pain at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Fairly large red spot - 5 inch rectangular area in upper left arm), RASH (Ring around red spot - left arm, rim around it and the inside part is fading), VACCINATION SITE PRURITUS (Itching at the vaccination site - left arm), VACCINATION SITE PAIN (Bit of pain at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot). At the time of the report, RASH MACULAR (Fairly large red spot - 5 inch rectangular area in upper left arm), RASH (Ring around red spot - left arm, rim around it and the inside part is fading), VACCINATION SITE PRURITUS (Itching at the vaccination site - left arm), VACCINATION SITE PAIN (Bit of pain at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site - left arm, fairly large red spot 5 inch rectangular area in upper left arm, ring around red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
Started 1-12-15. Scattered pustules, malaise (a few days later sib had same). Received varicella in our office 1-26-06, 08-05-09.
Pt was seen for pain over R lower ribs but was afebrile and well; normal exam and no pain. Menactra was given around 09:54 AM on 9/26/05. Around 2 hrs later she came in complaining of headache (heavy head), chills and fever of 103.8. She was given Tylenol and observed. Fever went up to 104-105 and ibuprofen was given about 1 1/2 hrs later and she was discharged soon after.
Reporter did not have any information regarding this adverse event. Reporter indicated that he heard a pt exp numbness/paralysis p/ 2nd dose of Engerix B.
Local erythema, edema, tenderness 6 x 4cm at site injection one day prior. No fever. Treatment-cool compresses, Tylenol prn, Benadryl prn.
headache; sweats; chills; being sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (being sick), HEADACHE (headache), HYPERHIDROSIS (sweats) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21N) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (being sick). On 26-Mar-2021, the patient experienced HEADACHE (headache), HYPERHIDROSIS (sweats) and CHILLS (chills). At the time of the report, ILLNESS (being sick), HEADACHE (headache), HYPERHIDROSIS (sweats) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This case was reported by a consumer via call center representative and described the occurrence of generalize urticaria in a 31-year-old female patient who received FLUARIX QUADRIVALENT (batch number BS79K, expiry date 30th June 2016) for an unknown indication. Concomitant products included contraceptive nos (Birth Control). On 16th October 2015, the patient received FLUARIX QUADRIVALENT. On 17th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced generalized urticaria, face edema and eye edema. The patient was treated with BENADRYL and prednisone. On an unknown date, the outcome of the generalize urticaria, face edema and eye edema were recovered/resolved. The reporter considered the generalized urticaria, face edema and eye edema to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on left arm at the hospital last year 2015. The patient experienced hives all over her body, facial edema and eye edema. It was now flu season and trying o determine what part of the shot caused the reaction. The reporter stated that there are 2 manufacturers written on my paperwork. If so I would like as much information as I can get of the ingredients in that vaccine so that I can determine what the allergen would have been. The patient went to urgent care due to issues. The patient received an automated reply confirming receipt of information.
I stayed at the pharmacy for the suggested 15 minute time frame to make sure I didn't have any serious reactions. About 45 minutes later, instead of the fatigue I was told to expect, I got really amped up and hyperactive. Along with the hyperactivity came extreme anger and irritability, to the point of rage. I felt almost out of control and felt like I had to potential to get very violent. I didn't. But the irritability/anger was that bad.
Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days); Ache on bones; Pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Ache on bones), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days)) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 032L620A) for COVID-19 prophylaxis.     Patient had no allergies (medications, food and other products) Patient never had COVID test or diagnosis No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes (No improvement or worsening) since 2000, Blood pressure high (No improvement or worsening) since 2000 and Anxiety. Concomitant products included SERTRALINE for Anxiety, METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, GLIPIZIDE, GABAPENTIN and METFORMIN for Diabetes, OMEPRAZOLE for Stomach discomfort, FINASTERIDE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days)). In 2021, the patient experienced BONE PAIN (Ache on bones) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Ache on bones) and PAIN (Pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 29-Jan-2021 and dose 2 on 06-Mar-2021 (more than 35 days)) outcome was unknown.            Indication for Finasteride was reported as for prostate and Omeprazole was for patient's stomach Patient did not experience similar events in the past   This case was linked to MOD-2022-604409, MOD-2022-604653 (Patient Link).
appendicitis/abdominal pain/fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a fever on 26Jan2021. She was having abdominal pain. She went to the emergency room and found out she had appendicitis. On 29Jan2021 (reported as six days after getting vaccine), she had to have emergency surgery and have an appendectomy due to have appendicitis. She mentioned she is following up finding out statistics with CML and appendicitis. She did not regret getting the vaccine, but she wanted to make sure events were reported. Like anything leaded to a hospitalization needed to be noted regardless if it was concluded to be related to the vaccine or excluded from being related. She mentioned she wanted to find out the most accurate up to date information on how many cases of Adverse Event reactions have occurred, related to appendicitis. She wonders if there is a website where she found this information. She did not want to look on internet and find inaccurate information. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported appendicitis with symptoms of abdominal pain and fever is considered related to the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
29Oct90 pt vax w/ MMR.  03Nov90 devel temp 103-104F for 3 days. would not eat and was vomiting. 07Nov90 devel generalized pruritic red rash for 4-5 days.  exp h/a + continually beat head + rolled eyes into skull.  See worm...
2 days after 2nd vaccination of Moderna patients left arm started to tingle from top of shoulder to finger tips, unable to grip, and injection site is sore.  No discoloration/deformity noted painful to touch. Patient states she saw her private doctor on 5/3/2021 the doctor referred patient to a nerve doctor appointment is 5/19/2021 and is following up with her private doctor on 5/132021. Patient was given V-Safe Health checker information for another way to report.
Patient is a 90 y.o. female patient of CNP with history of COPD, dementia, hyperlipidemia, hypothyroidism, history of CVA, history of seizure, chronic hypoxic respiratory failure likely oxygen only, who presented to the emergency room with shortness of breath and cough with minimal phlegm production, found to have COVID.    Acute hypoxemic hypercarbic respiratory failure Pneumonia secondary to COVID Concern of secondary bacterial pneumonia COPD with acute exacerbation Chronically on 2 L of oxygen at night only ABG on admission, PCO2 64 0.7, bicarb 35, bicarb 10 days ago was 27.  Acute CO2 retention.  Initially on BiPAP currently on 2 L of oxygen through nasal cannula.  Wean oxygen as tolerated. Procalcitonin normal.  Chest x-ray without any infiltrates. Unlikely superimposed pneumonia.  Stop antibiotics per Remdesivir, steroid. Symbicort and albuterol scheduled and as needed. Advair on discharge Dexa for 4 more days on discharge   Hypothyroidism, levothyroxine Seizure, Keppra History of CVA, aspirin and statin Hypertension, Imdur Still remains uncontrolled, add low-dose of lisinopril. Repeat labs tomorrow.   Covid-19 Virus Infection Date of onset of symptoms: 1/18/22 Symptoms present on admission: shortness of breath  Date of covid positive test: 1/19/22 Vaccination status: vaccinated Imaging: xary  Oxygen requirements on admission: 15 L nonrebreather then BiPAP Current oxygen requirements: 2 L NC Medical therapy: remdesivir and steroids Consultants following: Infectious disease Anticipated special isolation end date: 1/29/22    Severe protein calorie malnutrition Body mass index 14.8 Nutrition consult  Physical deconditioning Chronic fatigue syndrome PT OT Social service consult.
1/15/21 at 9:54 am was alerted to observation area.  Client attended by EMS.  Client stated she was having shortness of breath.  Client had removed her Oxygen that she usually uses.  Client stated she felt better and was released to go home with her son.
Patient presented on March 24, 2021 to the hospital with fever/chills/anorexia/chest pain.  Patient had his first dose of Pfizer vaccine on February 27, 2021.  Patient reported flu-like symptoms for 1 week following with spontaneous resolution of symptoms.  Patient noted 1 week of being symptom free and then had return of intermittent chills with low grade fevers in the evenings and associated anorexia and nausea.  The last few days leading up to being seen on March 24 patient was noticing intermittent chest pressure.  Treatment included holding 2nd dose of Pfizer COVID vaccine and therapeutic/diagnostic thoracentesis on left side on March 29, 2021.  Bilateral pleural effusions (left resolved with thoracentesis + right no intervention) and pericardial effusion resolved without intervention.
Patient states he has had periodic pain that sometimes will radiate down arm.  He has stated that he gets shooting pain if he raises his arm up in certain directions.  He was asked about the area and he described it as normal coloration but is sensitive to touch and pressure.  He started getting more concerned as pain sometimes radiates to neck area.  He said it started out at just typical soreness but has gotten worse over the last 2+ months.  He has not been seen by a medical professional as of day of reporting (11/17/20).  We suggested that it be evaluated for potential treatment.
I had a Grand mal seizure after my COVID-19 Moderna vaccine on 25NOV2022 and previous to that I was having black out seizures.
Noticed reaction 1-30-18, swelling w/hardness, hot feeling, spreading redness, itching. C/O vaccine given too low. Recommended heat and acetaminophen and use arm to decrease soreness. TC to father, issue resolved.
This case was reported by a physician and described the occurrence of urticaria in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were not concurrent medications. On 23 January 2012 the subject received 1st dose of KINRIX in the left arm. On 30 January 2012, 7 days after vaccination with KINRIX, the subject experienced urticaria and injection site redness (a symmetrical, circular, nonraised, red site reaction, 1 inch from the injection site). At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with KINRIX. Follow up information received from the physician on 14 February 2012. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined ;GlaxoSmithKline; unknown; unknown given on an unspecified date; diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified; unknown; unknown given on an unspecified date. The physician noted that the events were not serious. The KINRIX was administered as the 5th dose in the DTaP series as indicated. The physician reported that the subject developed "hives around the injection site 7 days after the injection". On 31 January 2012, the events were resolved. According to the physician, the events only lasted one day. The physician selected that the KINRIX immunization series was not discontinued or delayed.
On 5/6, the patient reports she was hospitalized on 4/14 after experiencing myocardial infarction, syncope, and fall resulting in the patient hitting her head
The mother of an 18 month old female reported that her daughter received an injection of Prevnar on 4/21/00. Ten to 14 days prior to immunization, the child developed an ear infection. The infection was initially treated with amoxicillin, then amoxicillin/clavulanate. On 4/22/00, the symptoms of the child's ear infection worsened. The child became listless, her fever became higher and she cried and held her ear.
Chills; flu like symptoms; Nausea; Myalgia; Headache; Fever; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 20:00 at a single dose for covid-19 immunization. He received his first dose (age of vaccination was 26-year-old) of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient's family history included his father has hypertension and hyperlipidemia. There were no concomitant medications. The patient received the vaccine in a university hospital which set up a clinic. The patient reported that he thought he got his second dose last night at about 8 pm and since then in the morning around 8 am, so about 12 hours after he started having flu like symptoms that got pretty bad one point. He took some acetaminophen (TYLENOL) so it has gotten better but he was having myalgia, headache, fever, chills and nausea. The patient further mentioned that first, he started having chills around 8 am in the morning. He had chills before but now he kind of overheated and now he is not under a blanket anymore, so he thinks that is improved. He then started having nausea, then myalgia and then everything kind of got bad all at once. He mentioned that over all everything has improved except the headache. He further added that everything has not gone away complete but improved significantly. Earlier today (14Jan2021) like 2-3 hours ago he would say it was a 7 or 8 on a scale of 0-10 but right now it is about 4 on a scale of 0-10 and that goes for everything. He does not think anything else is confounding, he is not on any medications and has no chronic health problems, there has been no labs drawn. The patient did not visit an emergency room and physician office. The outcome of the outcome of the event headache was unknown while the outcome of the other events was recovering.