chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Ache; Chills; Feeling miserable; Fever/Ache/Chills/Feeling miserable; This is a spontaneous report from a contactable consumer. This 67- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL3246), via intramuscular route of administration, on 19Jan2021 at 10:30AM (at the age of 67-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The medical history included: Blood pressure high, Diabetes, Hypothyroidism, High cholesterol, all from unspecified dates and ongoing. Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Concomitant medications included FLUTICASONE PROPIONATE (FLONASE) and montelukast sodium (SINGULAIR), both for Allergy. The patient received first dose BNT162B2 on 28Dec2021, (Lot: EJ1685, Expiry/NDC: Unknown), in right arm (Her arm hurt for about a week). Patient's Medical History (illness at time of vaccination): States that she was concerned because she thinks she has had a sinus infection for the last week; hasn't been feeling well. She told her doctor about it and asked if it was still okay to get the vaccine and was told that it would be fine. Prior vaccination included: Pneumonia vaccine - States that her arms swelled up and turned red the day she got the vaccine. The next day she had chills, fever, and body aches; and she had a rash on her arm that started the day after the vaccine. Her doctor told her not to get the vaccine again. She does not have the Lot/NDC/Expiry to provide because it was many years ago. Prior vaccination: Flu shot - She swells up and turns red at injection site; she also gets fever, chills, and body aches with it as well. She does not have the Lot/NDC/Expiry to provide; she got it back in Oct2020 at the Hospital where she works.  On 20Jan2021 03:00 AM, the patient experienced fever, aches, chills, and feels miserable. States that she reacts to the flu shot too, but nothing like this. Stated that all the events started in the early hours of the morning, around 3:00AM. She pushed herself to go to work, and it just got worse throughout the day.  States that she has been alternating Tylenol and Ibuprofen since early this morning. The outcome of events fever, aches, chills, and feels miserable was not recovered, got worse through the day was unknown.  No follow-up attempts are possible. No further information is expected.
Patient called clinic one day after vaccine given to report that 4 hours after vaccine given patient had symptoms of coughing, sore throat, itchy eyes/body aches and pains, pain in her eyes. She took BENADRYL and TYLENOL and felt better.
The first adverse event I noticed was a red, inflamed and itchy rash at the site of the injection. It was slightly painful and warm to the touch. I spoke with a few others who experienced similar reactions.  I took over the counter antihistamines in an attempt to treat it for several days.   One or two days after the rash appeared I started to feel sharp intense pain in my groin and around the vaginal opening to the point that it interfered with me sleeping and sitting comfortably. I have had a history of muscle spasms and vaginal pain (vaginismus, muscle contraction pain) but it was more intense and unprovoked which is why I wanted to reach out honestly? It?s a bit alarming. If other women/people with vaginas are experiencing this it would bring me some relief to know the cause and treatment.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002932: US-009507513-2105USA002936: US-009507513-2105USA002933: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002866:
1st Covid shot was Moderna administered 8/31/22 Lot# AR9236B given at different clinic site.
Shingrix underage administration to a 29 year old immunocompetent patient.; Shingrix instead of a second dose of a varicella vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old female patient who received Herpes zoster (Shingrix) (batch number 43D42, expiry date 16-SEP-2025) for prophylaxis.   Concurrent medical conditions included drug allergy (allergies to tramadol). Additional patient notes included immunocompetent .   On 06-NOV-2023, the patient received the 1st dose of Shingrix. On 06-NOV-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix underage administration to a 29 year old immunocompetent patient.) and wrong vaccine administered (Verbatim: Shingrix instead of a second dose of a varicella vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 06-NOV-2023 The practice manager reported that a 29 year old immunocompetent female patient received Shingrix first dose instead of the second dose of a varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
6 pm child received vaccine, IM then fell on floor. Parents at side and states child has not eaten. Patient encouraged to eat crackers and drink water.
Headache, extreme fatigue,  extreme exhaustion with sleepiness, and nausea. Pain from injection site up to neck and across to head.
TD given in LD 1st, then 5 minutes later, ped Hep-A given in RD. In 5 more minutes, client stated "I fell dizzy", got pale, head went back, legs straight out, body shook X 5-10 seconds and client lost consciousness briefly then sat straight up and asked "what's going on"? She was given O2 at 2 liters per minute per NM.
Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231), via an unspecified route of administration (left deltoid) on 09Jan2021 at single dose, for COVID-19 immunization. Medical history included celiacs, hypertension (HTN), thyroid disease, gastrooesophageal reflux disease (GERD), migraines, allergies: celiacs (gluten), and allergies: culturelle. Concomitant medications included levothyroxine and prednisone which was stopped 4 days prior. The patient previously took dilaudid and experienced allergies and received first dose of  bnt162b2 for COVID-19 immunization on 18Dec2020, 13:15, left arm (lot ELO140). On 11Jan2021, the patient experienced severe night sweats, body aches and low grade temps continuing growth off and in since second vaccine. Patient reported to have missed work. This has been going on for 3.5 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. Outcome of events was not recovered.
I woke up this morning with a 4 inch by 3 inch rash on my left arm around injection site.  Does not itch and is not painful
The symptoms started with uncontrollable coughing, sneezing, and a runny nose. On December 5, 2022, it was very difficult to get out of bed. I had muscle aches, headache, and extreme weakness. I had loss of appetite, and my sense of taste was gone. Throughout the illness, I never had a fever. I didn't know what I was experiencing until a close contact informed me that she and the other passengers in the car we were in tested positive for COVID-19. My symptoms lasted for about a week and half. I took over the counter medications. I still have the cough, but I started feeling 90% better around the December 17, 2022. My sense of taste and energy returned. I sneeze occasionally, but the headaches are gone as well.
I woke up at 6 am on March 3, 2021 with an excruciating pain in my left upper arm that extended to my left elbow. It was a 10 of 10 in severity. It felt like when you hit your elbow crazy bone on something. But it didn't start to subside until after an hour when I put ice packs on it. It was around 3 pm on March 3 when I felt like the pain was bearable. But I had a bad headache so I took Tylenol, which helped. After talking with another pharmacist, at 7:30  pm on March 3, 2021, she said the needles available on March 2, 2021 were longer & thicker than the ones available on March 3, 2021. She said it sounds the administrator may have hit a nerve when he gave the shot. I remember it felt like he had gone much deeper than my first dose.
Patient received vaccine and entered waiting queue. Within 1 0 minutes, pt requested help from pharmacy vaccination team because she felt severely dizzy. Patient ended up passing out in seated position. Systolic blood pressure dropped to ~80. Patient normalized 5-10 minutes after syncope. Blood pressure normalized. Patient escorted out in stretcher.
Nausea, dizziness, syncope, and migraine headache.  Treatment included ibuprofen, acetaminophen, and loratadine.  Unable to work for first week, symptoms slowly abated over the course of eight weeks.
Pharmacist administered less than total dose of vaccine most likely due to needle malfunction. Manufacturer and MD were notified and shot regiven 1 month later.
Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and PRURITUS (Itchiness) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itchiness). The patient was treated with CORTISONE ACETATE for Itching, at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included cortisone cream.   Reporter did not allow further contact
Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95%. Had a rough morning and was a bit anxious. Let the patient vent about her day - SOB resolved.
congestive heart faillure; symptoms of shortness of breath; dyspnea on exertion; palpitations/ heart racing; drop in ejection fraction; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 18Feb2021 (Batch/Lot number was not reported) (at the age of 66 years old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included adenocarcinoma of lung, anemia, aortic valve replacement, atrial fibrillation, benign essential hypertension and beta thalassemia. The patient previously took hydrogen peroxide and Tylenol, and experienced drug hypersensitivity; and first dose of bnt162b2 in Jan2021 for COVID-19 immunisation. Facility type vaccine: Doctor's office/urgent care. It was unknown if there are other vaccine in four weeks. There were other medications in two weeks. On 28Feb2021, the patient experienced congestive heart faillure, symptoms of shortness of breath, palpitations, heart racing and drop in ejection fraction. She started complaining of symptoms of shortness of breath with dyspnea on exertion 10 days later, 28Feb2021. Also noted palpitations with a heart racing. No chest discomfort, cough, or fever. She presented to MD with congestive heart failure (as reported). Echocardiogram that had been taken 06Aug2020 demonstrated an EF of 60%. Echo 24Jun2021 demonstrated ejection fraction of 25%. Echo 07Aug2021 demonstrated ejection fraction of 35 to 40%. No good explanation for drop in ejection fraction. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment for the events was received. No covid prior vaccination and unknown if  covid tested post vaccination. The patient underwent lab tests and procedures which included echocardiogram: ejection fraction of 60 % on 06Aug2020, echocardiogram: ejection fraction of 25 % on 24Jun2021 and echocardiogram: ejection fraction of 35 to 40 % on 07Aug2021. The outcome of the event was not recovered.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the reported information ,a causal relationship between the events  and suspected drug cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
IPV inadvertantly given at 1 year well child check instead of Prevnar (has now received 4 IPV vacc).
started to feel agitated,anxious, irritated; started to feel agitated,anxious, irritated; started to feel agitated,anxious, irritated; injection site was sore but it went away; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (started to feel agitated,anxious, irritated), ANXIETY (started to feel agitated,anxious, irritated), IRRITABILITY (started to feel agitated,anxious, irritated) and VACCINATION SITE PAIN (injection site was sore but it went away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore but it went away). On 15-Jan-2021, the patient experienced AGITATION (started to feel agitated,anxious, irritated), ANXIETY (started to feel agitated,anxious, irritated) and IRRITABILITY (started to feel agitated,anxious, irritated). At the time of the report, AGITATION (started to feel agitated,anxious, irritated), ANXIETY (started to feel agitated,anxious, irritated) and IRRITABILITY (started to feel agitated,anxious, irritated) outcome was unknown and VACCINATION SITE PAIN (injection site was sore but it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment  medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-076594 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076594:Case for Dose 1
local swelling elbow to shoulder-pink, hot used ice;low grade fever;out of work x 1 day;tender;resolved 24-30hr later;pt states had pneumonia shot last year & hand no rxn;
Noticed itching Wednesday evening. Saw large welt. Takes Benadryl or Allegra every day. Came in to office 7/9/04. 60cm diameter with center 30cm diameter: raised, red, hot . Center is distinctly redder. Topical Benadryl (gel x strength applied 7/9/04._
SHE INSTANTLY COMPLAINED OF BURNING AND A RAISED LUMP/WELT APPEARED AT THE SITE WHERE THE VACCINE WAS INJECTED (ALMOST LOOKED LIKE A MOSQUITO BITE). THERE WAS SIGNIFICANT REDNESS AROUND THE AREA. HAD PT. REMAIN IN PHARMACY FOR 15 MINUTES. NO SHORTNESS OF BREATH OR ITCHINESS, JUST A RAISED BUMP WITH REDNESS. CALLED A FEW DAYS LATER AND PATIENT SAID THE AREA WAS STILL SWOLLEN AND THERE WAS SOME BRUISING, BUT NEVER HAD ITCHINESS OR SOB.
1 week after administration, L shoulder joint started hurting, aching.  This has continued with decreased mobility in shoulder, difficulty sleeping if joint not positioned correctly.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients was vaccinated with improperly stored ROTATEQ, oral (lot # K011952 and expiry date of 17-JUN-2016) (unknown strength). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a multiple 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 PROQUAD, lot number M001150, expiration date 05-JUL-2017, lot number M022400, expiration date 01-NOV-2017, by subcutaneous route, (anatomical locationa and dose number were not reported), for prophylaxis. The vaccines were reconstituted with sterile diluent (lot number as reported K015799, expiration date 19-JUL-2017), however the sterile diluent was stored within the recommended storage range. The PROQUAD was between 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) during a time frame of 15 minutes. The PROQUAD had a previous temperature excursion. The digital data logger was not involved. No product quality complain was involved. No adverse effects were reported.  This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007501:
On 2/18/00, the pt received her 1st injection with Engerix-B. On 3/6/00, she had a pregnancy test which was positive. The pt's last menstrual period was 2/6/00 and the estimated date of delivery was 11/13/00. She had been pregnant for 6 weeks on 3/15/00. The information received on 1/12/01, reported the pt had a miscarriage. No further details were provided. This report was assessed as medically serious. Additional information has been requested.
The pt experienced swelling and redness to his left shoulder where his DTaP was given two days prior. A 15 x 20 cm are of erythema with induration was also noted.  Mother states that it has improved since the day before. Treated with Benadryl, ibuprofen and hydrocortisone.
<48hrs p/vax pt devel high pitch crying, 3 episodes lasting 15mins each; also had 1 episode of jerky movements of upper extremities off & on for approx 30mins; T101-102 x 48hrs; tc to PMD no treatement required;
She saw there was another girl who got the same thing and they said this was hemiplegic migraines and the shot caused it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPLEGIC MIGRAINE (non-serious), outcome "unknown", described as "She saw there was another girl who got the same thing and they said this was hemiplegic migraines and the shot caused it". Additional information: The reporter wanted to know what the treatment was for the girl (patient) to help her daughter.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------------  ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/1/2021 LEFT VENTRICULAR MURAL THROMBUS CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/10/2022 LEFT VENTRICULAR MURAL THROMBUS HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/24/2022 LEFT VENTRICULAR MURAL THROMBUS HYPOXIA 9/1/2021 LEFT VENTRICULAR MURAL THROMBUS ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/1/2021 ASPIRATION PNEUMONIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/10/2022 ASPIRATION PNEUMONIA HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/24/2022 ASPIRATION PNEUMONIA HYPOXIA 9/1/2021 ASPIRATION PNEUMONIA
Vaccine administered to patient on 7/13/2022 was expired on 7/9/2022. This error was noted when patient returned on 9/6/2022 for catch up vaccines. Patient was administered DTAP/IPV vaccine at this visit to correct the error. ( Parent declined the HIB) Parent did not report any adverse reactions to the expired vaccine.
Painful Lymph nodes near armpit and collarbone; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced painful lymph nodes near armpit and collarbone. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event painful lymph nodes near armpit and collarbone was recovered with sequelae on an unknown date.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.