chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored M-M-R II rHA lot number N014482 with expiration date of 10-MAY-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) and Merck sterile diluent for prophylaxis (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion 47.3 °F for 50 minutes and 34.9 °F for 1 hour. There was previous temperature excursion reported as 47.5F 48 minutes and 35.4F for 30 minutes. A "data logger" was involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1810USA003389: US-009507513-1810USA003390.
No additional AEs; Vaccine administered after temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 19-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, lot number U019286, expiration date: 15-DEC-2022, administered subcutaneously as prophylaxis (strength and frequency were not provided). It was reported that the vaccine had experienced a temperature excursion (product storage error), for 8 hours and 5 minutes at 6.8 degrees Fahrenheit, no previous temperature excursions were reported. No additional events were reported. At the time of reporting, the outcome of the event was not known.
Chief complaint: Fever. Patient is here because of a fever for the past 3-4 days. He has had no cough or cold symptoms. His appetite has been diminished, especially for solids. He has been drinking his milk. He has had no vomiting, no diarrhea. No known exposure. There is no rash noted. He has been otherwise healthy. He did have his usual immunizations just about 8 days ago. He had PedVax, Prevnar, MMR, and Varicella vaccine. Allergies: He has no known drug allergies. Objective: General: Alert, non-toxic, in no acute distress. He felt warm to touch. His temperature is 103.3. Respirations are normal at 24 per minute. HEENT: TMs are within normal limits. Eyes are not injected. No discharge. Oropharynx is within normal limits. Tongue is moist. Mouth and lips have no excoriation or micocutaneous peeling. Neck: No adenopathy. Chest and Lungs: Clear, with no rales, rhonchi, or wheezing. Heart: Regular rate and rhythm, with no murmur. Abdomen: Soft and non tender, with no hepatosplenomegaly. Extremities: Hand and feet are not swollen. Skin: No rashes. Assessment: Fever, most likely a viral syndrome, or related to his MMR. He currently does not have any rash, and is otherwise nontoxic.
Information has been received from a RN concerning a 69 yr old female who in 1999 and on approx 01Nov05 was vaccinated with a first and second dose (lot 649693/0496P) of pneumococcal 23v polysaccharide vaccine (0.5ml) (IM), respectively. On 08Nov05 the pt experienced significant swelling from her elbow to her shoulder. It was also reported that the pt developed painful, swollen, red arm. The pt was reportedly recovering. Additional information has been requested.
Patient received the Pfizer covid vaccine on 12/17/2020. She reports that she has new onset of itchy throat, dry cough started 1 day after her vaccination on 12/18/2020. Able to sleep at night. Cough is persistent on and off for 4 days now. Denies fever, chills, bodyaches, or HAs. No other symptoms  She has an appointment at Employee Health on 12/21/2020 at 3:30 pm for Covid PCR testing.
The patient was scheduled for his 18 mo well visit. He was scheduled to receive his Pentacel, dose 4 in series and hepatitis  #2 in series.  I drew up the vaccines and administered them. I realized about 15 minutes after the patient left that i administered the Hepatitis B vaccine rather than the hepatitis A vaccine.  I called the family and informed mom of the error. The patient was doing fine and without any negative adverse reaction.  I explained that he may not experience any adverse reaction but to call if any concerns. She was very understanding and appreciated the call and stated she will call to schedule his second Hep A vaccine.  He did not experience any negative reaction.
In the fall of 2017 I began gradually experiencing hoarseness of voice, as well as swallowing difficulties. Then subtle left arm and shoulder weakness. This was all very gradual in onset and intensity. I saw my internist, who referred me to ENT. I also saw neurologist. Dr. detected partial vocal cord paralysis on the left by way of laryngoscopy. Dr. assessed left arm and shoulder weakness.  Ultimately, Dr. referred to another Dr. because it seemed there must be some global explanation for these symptoms appearing all at about the same time. Dr.'s opinion is that I have a chronic neuropathy caused by an adverse reaction to my flu shot.
Information has been received from a RN concerning a 75 year old white retired female with chronic renal failure, no acute illnesses and an allergy to erythromycin who on the evenings of 05/21/03 and 06/18/03 was vaccinated IM in the right deltoid with a first and second dose of the dialysis form of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 644028/1017M).  After the first vaccination, the pt developed localized erythema with injection site swelling and redness and a hard lump developed at the injection site.  On the afternoon of 06/18/03, after the second injection, the pt developed generalized hives.  The pt took oral diphenhydramine (Benadryl) at home "which helped).  On 06/19/03 the pt recovered.  It was reported that the third vaccination would not be given.  It was also reported that the pt stated that she has reactions to all vaccines.  Unspecified medical attention was sought.  No diagnostic studies were performed.  No product quality complaint was involved.  No further information is expected.
pt states was most painful inj;MD stated injected into the nerve;2hr later rt eye constant watering-rt side of face paralyzed
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Wrong Route (SC, IM, etc.)-
No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 4-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004878: US-009507513-2108USA004892:
Headache, Diarrhea, right sided stiffness and tingling, lower back pain Narrative:  Other Relevant History:
Tested positive for antibodies after 1st dose; Fever; terrible chills; Felt miserable all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (terrible chills), FEELING ABNORMAL (Felt miserable all over) and COVID-19 (Tested positive for antibodies after 1st dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (terrible chills) and FEELING ABNORMAL (Felt miserable all over). On 10-Mar-2021, the patient experienced COVID-19 (Tested positive for antibodies after 1st dose). At the time of the report, PYREXIA (Fever), CHILLS (terrible chills), FEELING ABNORMAL (Felt miserable all over) and COVID-19 (Tested positive for antibodies after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for events include paracetamol.   Reporter did not allow further contact
Reddened area around site. No SOB, no fever. Pt has taken BENADRYL, also no chest pain.
Patient received vaccine on date 21-APR-2022  which was expired on 22-JAN-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 21-APR-2022  which was expired on 22-JAN-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 21-APR-2022  which was expired on 22-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 21-APR-2022  which was expired on 22-JAN-2022) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received second booster dose.  No treatment medications were reported
FLU-LIKE SYMPTOMS; HEAD COLD; 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: not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms, and head cold. Treatment medications (dates unspecified) included: oseltamivir phosphate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and head cold. This report was non-serious. This case, from the same reporter is linked to 20210705017.
Injection site reaction- area is red and warm to touch -took Benadryl approximately around 5pm on 8/17 and hydrocortisone cream around noon 8/17
ended up getting Covid; This is a spontaneous report via a Pfizer Sponsored Program COVAX US Support from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got 1st dose on 10Mar2021 and then on 20Mar2021 ended up getting Covid. Patient would like to know how long one should wait to take the 2nd dose of the covid vaccine if they have contracted covid. And wanted to confirm that 6 weeks is the maximum time allowed between doses in order to receive maximum efficacy. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness; Swollen; Left arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Left arm is painful) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Left arm is painful). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Left arm is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included thyroid medication.  Treatment information was not provided.  Patient reported that the reactions have gotten worse since she received the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Child was "extra sleepy" and fell asleep on chair at 5 p.m. Grandmother checked on child at 5:20 and "she couldn't wake him up. His eyes were off to the side. He felt warm. His nail beds and lips were very blue." Mother called ER. States that child started to choke and was "drooling everywhere". Temp in ambulance was 104 deg. Received albuterol via nebulizer x 2 in ambulance, x 3 in ER. "He didn't really come to until he got to hospital." Discharge at 9 p.m.
pt recv vax 6/95 & in 2/98 pt exp ``very severe'' chickenpox. pt treated w/Zovirax
While administering vaccines MMR and Varicella, patient began immediately having redness start @ injection site and spread to about a 50% area around both injection sites. Pt immediately evaluated by physician and given BENADRYL and TYLENOL. Patient was monitored for 15 minutes.
Information has been received from a female registered nurse who in 1970 was vaccinated with a dose of rubella virus vaccine live.  In 1970, the patient developed temporary arthritis in her hands for three months.  The nurse's arthritis was not considered to be life threatening.  The symptoms did abate after three months.  It was also noted that the patient's age was 21 at the time of the event.  It is unknown if medical attention was sought.  The patient reported that she received the MMRII vaccine (no lot number reported) (MSD) on 12/12/2002 with no symptoms.  No further information is requested.
Patient received smallpox vaccine on 4April06 after receiving a briefing on the care of smallpox vaccination sites and soldier also verified the care of vaccine site with the immunization provider and the PA prior to being vaccinated.  Patient returned to the clinic on 10April 06.  He stated that he had gotten a tattoo on 7April06 and that he now has bumps around the tattoo and was not sure if it was from the smallpox vaccine or from a reaction from the tattoo.  Patient was instructed to cover bumps and to monitor them for changes and to return to clinic for further changes.  Patient returned to clinic today.  Bumps have been spreading to arms and torso, each site covered with gauze, tape and ace wrap.  Patient instructed to return to clinic every morning for bandage changes.  Patient again given instructions for care of inoculated sites and was told to change bed linens, wash towels, and to spray with bleach all surfaces he had touched.  Patient also reported to his chain of command.
pt recv vax 17SEP98 & 24hr post vax, pt stopped moving;family didn't know it was abn; pt checked 1mo later & had major nerve abn;now pt has mild movement in arms;pt hosp & feeding tube/tracheostomy being considered;pt "almost died yesterday;Annual follow-up received on 11/27/00 provides no additional data.
RASH TO BELOW BOTH EYELIDS/ RASH AROUND BOTH EYES/RASH TO FOREHEAD/RASH TO SIDE OF FACE/ TO BOTH EARS/ TO SIDE OF NECK; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 180 pounds, and height was 55 inches. The patient's past medical history included surgeries for cleft lip and palate, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. the patient not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced rash to below both eyelids/ rash around both eyes/rash to forehead/rash to side of face/ to both ears/ to side of neck. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from rash to below both eyelids/ rash around both eyes/rash to forehead/rash to side of face/ to both ears/ to side of neck. This report was non-serious.
Patient woke up in the morning and arm around site was red, hot, swollen, severe headache and chills which lasted into the next day, after four days the site is still swollen, red, and itchy now.
08/30/21 The patient presents with Pt reports he was vaccinated and he started feeling sick more than 10 days ago. He reports he went to his PCP and tested positive for COVID and he got a Z pak and prednisone and he was monitoring his oxygen at home and he dropped to the 70s. He also reports he got the regeneron a couple days ago but because of the low oxygen he came in..  The onset was more than 10 days.   Patient reports that on August 17th he started having symptoms that included sob, loss of taste and smell, coughing.  He tested for covid on the same day,  and he got positive results on the 20th..  He has experienced weight loss  also.  He received Regeneron  3 days ago, but has not found any  improvement.
arm is sore; don't feel so good; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received Shingrix and the arm was so very sore plus the patient did not feel so good.
I was scrolling through social media, and then I suddenly realized that I was having difficulty reading. I could see the letters clearly. There was no problem with my vision, but I couldn't put the letters together to make out what the word was. I couldn't understand the what the word was. It felt like I was experiencing Alexia. I was suddenly unable to read due to my brain not being able to process the information properly. The problem resolved within 15 minutes, but I still went to the ER that same day on 11/4/2021. At the ER, the doctors assumed that I was at risk for a stroke, so they did a lot of tests very quickly. They said I have mild anemia and a bifascicular block. They said they think I might have TIA. I had stopped taking the baby aspirin a week before this had happened, so they said to start taking them again. They also thought that I was low risk for a major stroke. This occurred more than a month after my vaccine, and I doubt that it was related to the COVID 19 vaccine.
Condition aggravated; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   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-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant drugs were not reported. On 22-Oct-2021, patient received third dose/booster dose of Moderna vaccine. No treatment medication information was given
Pt had MMRV on 12/20 with swelling, see dr. At 1217 spoke with mom. Noticed some swelling of pts arm last night. Mom states swelling is large, area is red, larger than an inch. Denies red streaking/fever. Arm is itchy. Bartin Schmitt protocol used, call nurse back if symptoms worsen, and make appointment for today. Barton Schmitt protocol given: immunization reaction.
Case number PHEH2014US018791, is an initial spontaneous report from a pharmacist received on 16 Sep 2014. This report refers to a female patient of an unknown age. Past medical history and concomitant medication was not reported. Her last menstrual date was not reported. This pregnant patient received FLUVIRIN (batch number: unknown) from a multiple dose vial intramuscularly on an unknown date. No adverse event reported following vaccination.
client recieved Gardasil vaccine and then became diaphroetic pale and began to wheeze. 911 called We checked her vitals, bp 80/60 pulse 56-64. Ice applied to arm and forhead and she was placed on a mat. Juice and crackers recieved. Ems arrived and vitals were reevaluated. Stable at this time.Mother refused further EMS treatment but was  instructed to call if further problems. We will call in a.m. for follow up.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), METFORMIN for Diabetes mellitus, ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). The patient was treated with IBUPROFEN for Pain in arm, at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.