chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 07-Jul-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and was administered on 07-Jul-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. Patient received half dose. The vial did not undergo any temperature excursions. No treatment medications were reported.
Severe pain in the left shoulder (where vaccine was administered).  Joint immobility left shoulder.  Awakened in middle of night from sleep by the pain. No fever, no redness at injection site.
08/17/2005 Approximately 48 hours after immunization, right arm was slightly raised.  No treatment needed, will follow up as needed.
Swelling and redness R/A deltoid and rash looking redness that spread to back side of R/A. Itching. C/o no pain.
Rash all over body hives, red welts.  Started on RT side of body and then spread.
". I was at patients home yesterday and I began to feel really flushed to my head to the point where it felt like my face was burning. My back of my scalp became itchy. So I ended my visit and took some Benadryl. The redness spread to my upper chest and arms. I slept for several hours and felt much better when I got up. I feel fine today. "
mildly sore arm for a day or two; This case was reported by a consumer via interactive digital 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. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced mildly sore arm for a day or two, just as he/she would have from any other vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
1) Massive  asthma attack.  Felt close to dying.  Breathing is still not controlled. 2) Excruciating lower left back pain.  Could not be alleviated with hydrocodone or even morphine.   Lasted 4 months. Tolerable now after        6 months. 3) Pericarditis 4) Extreme weakness. Could barely do daily routine chores.  5) Both legs and feet swollen tremendously.
30-year-old AD male with a past medical history significant for known NSAID allergies (ibuprofen, and aspirin cause angioedema). Patient received typhoid and Td on 5 September 2018.  Within one hour patient began to develop upper back pain and neck stiffness. Symptoms progressed in severity enough to prompt an evaluation by the emergency department on the same day, where he was prescribed ULTRAM and NORFLEX. However, he has been somewhat noncompliant with these medications due to the sedative effects of these medications and the requirement to continue to work. Patient specifically denies any red flags such as paresthesias, muscle weakness, generalized rash, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise associated with these or any previous immunizations.
had the worst headache she has ever had; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (had the worst headache she has ever had) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dry skin (Patient has dry and flaky skin for past 6 months). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), MIRABEGRON (MYRBETRIQ) and TROSPIUM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (had the worst headache she has ever had). At the time of the report, HEADACHE (had the worst headache she has ever had) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; off label use; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 as dose 5 (booster), single (Lot number: FJ6369) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: O25A27A), in left arm, on 30Mar2021 as dose 2, single (Lot number: O17B21A), in left arm, on 14Aug2021 as dose 3 (booster), single (Lot number: O40C21A), in left arm and on 07Jan2022 as dose 4 (booster), single (Lot number: D84J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Known allergies: Sulfa medications" (unspecified if ongoing), notes: Known allergies: Sulfa medications. Concomitant medication(s) included: WELCHOL; REMICADE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jul2022, outcome "unknown"; OFF LABEL USE (medically significant) with onset 07Jul2022, outcome "unknown"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Sep2022) Negative, notes: three days of negative tests; (Sep2022) Negative, notes: three days of negative tests; (Sep2022) Negative, notes: three days of negative tests; (Sep2022) Positive, notes: still testing positive; (12Sep2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03Sep2022, Treatment stop date: 08Sep2022, Lot number: 2815238, Indication: Treatment of COVID-19. Covid symptoms returned and tested positive on lateral flow antigen test on 12Sep2022 after three days of negative tests and no symptoms. Still testing positive with symptoms and other medication in 2weeks brand Janssen.
Onset malaise & muscle aching 7DEC PM followed by fever ("hot"), chills, diaphoresis, congestion, cough & h/a on 8DEC sx persisted through 12DEC91;
WOKE UP WITH COUGH.  ON 9/26/13 WOKE UP WITH 102 DEGREE FEVER WITH ACHES, CHILLS, SORE THROAT.  TURNED INTO FULL BLOWN UPPER RESPIRATORY INFECTION.  9/28/13-LEFT EAR PLUGGED UP, BOTH NOSTRILS PLUGGED UP.  10/14/13- HAD RESIDUAL EFFECTS OF TRANSVERSE MYELITIS (HAD IN 2006/2007) AND OCCIPITAL NEURALGIA.  11/4/13- EAR IS STILL PLUGGED UP AFTER 3 DOSES OF ANTIBIOTICS AND TWO DOSES OF STEROIDS.
pt recvd vax & 1-2 hrs p/vax called clinic c/o single itching welt; back of neck 245 felt many more welts mid har to shoulders, no swelling throat, breathing difficulty-husband present-advised immed medical attention;
Swelling of left supracervicle lymph nodes with pain and tenderness in left axillary region
Pt recvd MMR vax @ 12 months w/no noted problems; On 02JUL91 recvd booster dose of MMR & 20JUL91 exp sore throat, 2 days later throat soreness progressed to angioneurotic edema of palate & throat; Hospitalized & treated w/Ancef;
pt states about 48 hours after getting the Moderna Booster (she was given the full dose not the half dose after getting 1st and 2nd dose of Pfizer covid vax) she became extremely weak.  Her vision became blurry, her balance was off and her spatial differential was impaired.  She feels like it exacerbated her MS symptoms. On 1/29/22 she fell out of her wheelchair hitting her head causing her to have a concussion.  She was worried she had broken her neck so she call 911.  She was taken to the ER where she was admitted for treatment.  She says her weakness has subsided a little now but she still has balance and vision problems.  She does not believe anyone should get the full dose for the booster or anyone with immune disorders.
Patient registered with birthdate of 2004, and after vaccination corrected to 2005.  Patient accompanied by parent.
Pt stated she has redness, swelling, pain, slight itch, and warm to touch to injection site. Pt is applying ice packs to area 15-20 minutes three times a day. Pt states after 8 days since injection she is feeling a little better, still feeling warmth to area, redness, swelling, itching. Pt is not having breathing difficulties.
Fever for approx. a day, significant leg swelling and erythema prompting ER visit and diagnosis of cellulitis with improvement on Augmentin.
COVID test positive; COVID test positive; congestion; head pressure; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 27 years as dose 2, single and intramuscular, administered in arm left, administration date 06Feb2021 (Lot number: EM9809) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "not recovered" and all described as "COVID test positive"; NASAL CONGESTION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "congestion"; HEAD DISCOMFORT (non-serious) with onset 20Dec2021, outcome "not recovered", described as "head pressure"; NAUSEA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, head discomfort, nausea.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Patient described arm pain and a heavy feeling within 15 minutes which she attributed to a general reaction to a shot. Upon waking the next day, her bicep showed redness, stinging, and was warm to the touch. It was also sore and felt bruised.
Itchy eyes 2 hours later. With second dose, she had flushing across chest right away, resolved with Benadryl.
Patient received first dose on 12/29/20 with no complaints.  Patient received second dose on Tues 1/19/21 and waited 15 minutes.  He had no complaints.  He returned to work and finished his shift.  Patient went to gym, after work at 6 pm.   As he started to workout he felt dizzy.   He rested for a few minutes then made his way to dressing room.  He started feeling nauseated and cramping in lower extremities.  He reported having difficulty vomiting but after one episode he felt better.  He called his wife who called attendant.  They called EMS.  He made his way out to the ambulance with help from the attendant. He continued to have cramping in legs and then stomach.  EMS assessed him.  His blood pressure was high.  Patient and his wife decided to not go to ER.  EMS released him and he went home.  Patient continued feeling light headedness, dizzy and having nausea and vomiting till around 11 pm.   Today, he reports feeling better but continuing to feel dizzy.  He is following up with doctor today.
During administration the syringe exploded and the syringe needle didn't seem to retract so sent patient to ER for removal (but found out it was broken off in her arm).
Infant several hours after vaccines were administered developed nausea, pallor, lethargy, circumoral cyanosis. No apnea was noted.
Shortly after receiving booster vaccine, patient started having side effects like headache, fever, chills and body ache. These symptoms lasted for about a month. Patient had visited urgent care and emergency room and upon blood work she was told she has hyperthyroidism developed after getting her pfizer vaccine. She had also experienced thyroid enlargement and neck pain lately.  Her heart rate is constantly higher after receiving the vaccine.
10/31/13 ZOSTAVAX administered. About 11/23 rash - dense clustered papules at injection site, but also scattered papules arms, legs, back, neck. Papules evolve to dry flaky circles.
6/21/06 Vaccine administered. 6/22/06 Arm swollen. 6/23/06 Left arm swollen from shoulder to elbow, red streaks. 6/23/06 Seen at clinic. Prednisone 5mg and Cephalexin QID for 4 days.
I received the shot on Thursday morning and was fine through the day and worked the next day (Friday).  Friday evening I began to feel aches in lower legs and a headache.  My temperature, which is normally 97.3 or below went up to 100.8.  My wife gave me a tylenol and I went to bed.  I felt great the next morning.  On Sunday I felt well enough to mow the lawn.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patients received improperly stored ZOSTAVAX (lot # L006379, expiration date 25-MAY-2016, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Boostrix given in less than the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix given in less than the recommended interval). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-MAR-2023 The reporter reported that multiple patients received Boostrix in less than the recommended interval.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. At the time of reporting, the patient received Boostrix in less than the recommended interval, which led to inappropriate schedule of vaccine administered. The reason why other patient's received 2 doses in less than recommended interval was not clarified. This case was linked with US2023043196 reported by the same reporter.; Sender's Comments:  US-GSK-US2023043196:Same reporter
TIGHTNESS/WEAKNESS IN ARM, BUMPS IN ARM, FEVER/CHILLS.
I had the vaccine the evening of 03/02/2021. I developed fatigue, chills, and a fever the next day. The following day, 03/04, my fever reduced, but that early evening, I started feeling tightness in my chest. I woke up around 3-4 AM on 03/05 because I thought I had to use the bathroom. I passed out and hit the floor. I woke up and went back to bed. I called my doctor in the morning, even though I was feeling a bit better. She told me to go to the ER right away. At the ER, Hospital Center, they performed a D-Dimer test and it was off the charts. I ended up in the hospital for 4 days. They performed a doppler on my leg, CAT scan, and found a blood clot there, multiple spots in my right lung and one in my left. I was put on Eliquis for 6 months. I recently went back to have a check-up and everything was clear and I was taken off of the Eliquis.
Decreased feeding, blood in stool, fussy = Intussusception. Reduced by barium enema.  Hospitalized for one day.
Cold sores broke out on lower lip 1 day after given injection. Abreva cream applied twice per day. The lesion was not changed.
Seems like heart rate is increased; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number: EL9264) via unspecified route of administration on 01Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified dose for COVID-19 immunisation. As per reported consumer stated, "I got the second Pfizer COVID-19 Vaccine (later confirmed) on the 01Feb and I, wear a fitbit and it seems like my heart rate is increased. When paraphrased the concern, consumer stated, "Right." Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
she experienced itchiness on her arm after the second vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (she experienced itchiness on her arm after the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection and Cold sores lip. Concurrent medical conditions included Multiple allergies. Concomitant products included DOXYCYCLINE for Urinary tract infection.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (she experienced itchiness on her arm after the second vaccine). At the time of the report, PRURITUS (she experienced itchiness on her arm after the second vaccine) outcome was unknown.            Treatment medication were not reported The patient had taken prophylactic antibiotics for a long standing med history of urinary tract infections    This case was linked to MOD-2021-302212 (Patient Link).
Rescue Ambulance Report: ON SCENE TO  FACILITY FOR A 35 YEAR OLD M IN MILD DISTRESS, AOX3 GCS 15 W CC CHEST PRESSURE THAT BEGAN AT 4AM. PROVIDER IMPRESSION CHEST PAIN CARDIAC. PT STATES HE TOOK HIS FIRST DOSE OF JNJ VACCINATION YESTERDAY NOON. TODAY IN THE AM PT HAD DIFFICULTY SLEEPING AND WAS RESTLESS THROUGH THE NIGHT. PT WAS ABLE TO FALL ASLEEP AT 2AM AND AWOKE AT 4AM WITH CHEST PRESSURE, PALPITATIONS, AND FELT UNWELL. ON ARRIVAL OF RA PT HAS 5/10 CHEST PRESSURE WITH NO LASTING RELIEF FROM 3 SPRAYS OF NITRO. 162MG ASPIRIN ADMINISTERED, SINUS TACH ON 12 LEAD. NO LOC, NO SOB, NO NAUSEA OR VOMITING, NO NEURO DEFICITS, NO ABDOMINAL PAIN, NO OBVIOUS TRAUMA, NO OTHER COMPLAINTS. ALL MEDS AND TREATMENTS DONE BY ON SCENE PARAMEDIC . NO ADDITIONAL TREATMENTS WHILE ENROUTE TO HOSPITAL IN RA3. PT STATES THESE SYMPTOMS ARE IDENTICAL TO HOW HE FELT 6 YEARS AGO WHEN HE WAS DIAGNOSED AND TREATED FOR MYO PERICARDITIS. PT WAS ASSISTED ON TO GURNEY, SECURED IN AMBULANCE, TRANSPORTED TO HOSPITAL 139 PER PT REQUEST. IN STABLE CONDITION, MOVED TO HOSPITAL BED WITHOUT INCIDENT, TRANSFERRED CARE TO RN.
Symptoms general malise, discomfort starting at noon, not eating progressing to disorientation, non consolable until 6-7 AM next morning.  Tylenol administered 5cc with minimal help.  Minimal fever. Child hypersensitive to touch / consoling.
Constant runny nose and severe sneezing. Sweaty and chills. Temperature range 100-102. Dry cough, bad headheache.  Cough and dark phlegm after 5 days. All over body ache and tiredness.
She received vaccination HAVRIX (Hepatitis A) #1 dose of two - by the evening she developed itching progressively worse, then rash on hands on body. Was seen by dermatologist who administered corticoid IM & oral Rx. She improved and had " hands peeled off" - "still has some scarring on hands".
Pt recvd 3 doses of Engerix-B 17SEP90, 18OCT90, & 15MAR91 & it was determined that pt was not immun to Hep B;
felt sore for two days or three but not bad; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt sore for two days or three but not bad) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (felt sore for two days or three but not bad). At the time of the report, MYALGIA (felt sore for two days or three but not bad) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included cholesterol medicine. No treatment was reported by the reporter.   This case was linked to MOD-2022-510205, MOD-2022-510207 (Patient Link).
Edema Both legs  Lethargy Forgetting words.. Cramps in my legs Loss of strength Breathing is weaker..