chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 18-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
After 30 min observation patient complained she felt warm all over. She was hydrated and vitals were taken. She received enhanced observation and after additional 15 minutes she stated this resolved
ACUTE NON ST ELEVATION MI ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
I received my Covid- 19 vaccine on 09/25/2021. On 05/03/2022 I woke up with a sore throat cough and flu like symptoms. I took a home test and was positive for Covid-19. I then went to urgent care to confirm. I was prescribed PAXLOVID. I felt better after 5 days however after a day or two if feeling better I started to feel ill again. I felt the same sore throat, flu like symptoms. This lasted for about another five days. I did not seek medical attention again.
pt had approx 5 mins of tonic-clonic movements of extremities, eyes rolled up, unresponsive w/perioral cyanosis p/episode was irritable w/dec tone; temp 101.9 ax; OM
Oct.15th got flu shot. Oct 16th experienced weakness, fever, cough, sore throat, headache, really bad chills, muscle ache, fatigue. October 18 - 19 fever was 102. Mucus. Sneezing. As of Nov 1., no fever, but still weak.
Next day (per mom) red-lump, quarter size. Advised gentle massage, alternate with cool/warm compress, Tylenol or Ibuprofen as needed. Today, per mom very swollen, advised continue with comfort care office visit as needed, and will fill out VAERS.
On Day 1 (10/15) injection site became reddened. On Day 2 site became reddened, swollen, very painful, warm to touch and low grade fever (100.7) developed. On Day 3 injection site more swollen, extremely red and warm, painful to touch, fatigue, low grade fever continued. Left work early. On Day 4 (10/18) called in sick to work. Injection site is very red and swollen, warm to touch and very painful. Severe fatigue. Swelling has now traveled to left shoulder, left neck and throat and left side of face. Notified PCP, started a MEDROL DOSEPAK at 4pm on day 4. Day 5 (today) went to work, felt very good this morning but by 1pm swelling in left shoulder, neck, face and throat and low grade fever has returned. Also developed headache. Injection site remains red, not as bad as previous day but still warm to touch. Left side of throat painful.
p/vax pt had a large red knot to rt thigh but stated it is going down;mom states it is still red & large;mom told to bring child to ER;
Sore left arm at injection site, felt for two days and then subsided. Subsequently, seven days later I had two tiny eruptions on both of my heels, and thought they were bug bites. The next few days the eruptions continued on the small of my back (minor) and my lower legs, feet (but not soles) on the sides of my fingers and sides of my hands, nothing on my torso, face or neck or thighs. The eruptions continued and itched so badly that the only relief I could get was big icers covering my legs and deadening the itch.  Prescription cortisone didn't touch it.  I have photos of my rash
Pt became dizzy, weak, with nausea/vomiting X 2, runny nose and a sore throat. Oral temperature was 97.8F, heart rate was 92, blood pressure was 122/88 and respirations were 24. Breath sounds were clear and equal. Gave 2 Benadryl and called her doctor and she went to the doctor's office. FNP at doctor's office believes she should not receive #3 Hep-B, but thinks client is coming down with a cold.
myalgia started on 29MAY93 followed by neck et shoulder girdle pain et pelvic girdle pain; also back pain w/spasms then arthralgia et paresthesia of hands et feet; low grade fever; rash et itching across abdo then paresthesia; nose et lips;
Initial misuse report received from a healthcare professional on 12 April 2013. An expired dose of ADACEL was administered to a patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
has not received the 2nd vaccine; A spontaneous report  was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had not received the second vaccine.  The patient's medical history and concomitant medications were not provided.  On 18-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (lot number: unavailable) intramuscularly for prophylaxis of COVID-19 infection.  On 27-FEB-2021, the patient reported that she had not received the second dose of the vaccine yet.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, had not received the second vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot# unavailable, with no associated adverse events.
Intracerebral hemorrhage affecting left side. No symptoms before stroke.  Paralyzed on left side of body
Redness around injection site almost immediately; resolved with hydrocortisone cream. Area bruised and tender x 2 days; on 3rd day, again develoepd redness that spread 2/3 down upper arm and radiated to axilla. Started on Keflex 250mg po qid x 10 days. Symptoms started resolving within 24 hrs.
Inadvertently given Bivalent instead of monovalent Pfizer as 2nd dose of Primary series
Wife described reaction as having a fever, sweating, and achey about 12 hours after vaccination, then shakey legs in the morning after vaccination. The symptoms lasted about 12 hours, then was fine. Used no OTC medications to relieve symptoms.
pt recv vax 21OCT93 & exp a frontal h/a that lasted 3 days; pt also exp twitching sensation starting @ inj site & down to lower arm; pt recovered;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022 at 5:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Feb-2022 at 5:55 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  On 18-Feb-2022 at 17:55:42, Patient administered booster dose.   It was reported that patient received lot its 30 day expiry date. No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
I got very dizzy; im feling like my head is full and very painful; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I got very dizzy) and HEADACHE (im feling like my head is full and very painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I got very dizzy) and HEADACHE (im feling like my head is full and very painful). At the time of the report, DIZZINESS (I got very dizzy) and HEADACHE (im feling like my head is full and very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
OBSTRUCTIVE SLEEP APNEA 2/8/2023,  2/12/2023,  1/14/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Hives on vaccinated arm, other arm, and chest approx. 2 hours after vaccination
Patient comes in 12/18/21 and reports to me that after her booster shot on 11/29/2021, days later, she experienced tingling in the fingers, arm pain and a tightness in the back of the head. She consulted with her PCP and her ENT, whose care she was under. The ENT cleared her and her PCP told her to take 2 Tylenol.
Fever; This is a spontaneous report from a contactable consumer (husband) reported for a 57-years-old female patient (wife). A 57-year-old female patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on 11Mar2021 (age at vaccination: 57-year-old) as a single dose for covid-19 immunization. Medical history included Multiple sclerosis and Sjogren's. The patient concomitant medications were not reported. On 12Mar2021, patient experienced fever. Reporter was requested to contact nearest Physician in case of any emergency. Patient did not receive any treatment for the event. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Felt like he had a fever/temperature was 100.2 F, 100.0 F; second dose like 4 inches lower on my arm than the last dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Felt like he had a fever/temperature was 100.2 F, 100.0 F) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (second dose like 4 inches lower on my arm than the last dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     The patient's past medical history included Headache and Pain neck. Concurrent medical conditions included Sinusitis.    On 03-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced PYREXIA (Felt like he had a fever/temperature was 100.2 F, 100.0 F) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (second dose like 4 inches lower on my arm than the last dose). On 03-Feb-2022, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (second dose like 4 inches lower on my arm than the last dose) had resolved. At the time of the report, PYREXIA (Felt like he had a fever/temperature was 100.2 F, 100.0 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 F and 100.0 (High) 100.0 F.         The patient reported that second dose was closer to his bicep. No concomitant product information  was provided. No treatment medication information  was provided.   This case was linked to MOD-2022-473681 (Patient Link).
10/24/2021, I had a visual disturbance, looks like I was looking through many tiny prisms that lasted 15 minutes. No medical or laboratory test done was informed by the doctor to wait to see if it goes away.
This spontaneous report as received from a registered nurse refers to a 75 year old Female patient. The patient's medical history and current conditions are not reported. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US001232 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 15-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 13 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Pt reported to be at hospital on vent since Oct 2 2009 with Guillain-Barre syndrome.  10/21/09 Hospital records DC summary received service dates 10/2/09 to 10/20/09. Assessment: Death due to sepsis, respiratory failure, disseminated intravasular coagulopathy, acute renal failure, cirrhosis. Patient presented with hx of lower extremity weakness progressing to all four extremities. Was admitted to another facility where he became short of breath and hypoxic, intubated and developed ARDS. Neurological exam - areflexia severe axonal senserimotor polyneuropathy.Tranferred to MSU service for plasma exchange. Multiple infections including ventilator aquired pneumonia. DIC. Bloody stools. Metabolic acidosis, DNR, death.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; GENERAL MALAISE; This spontaneous report received from a patient concerned a 64-year-old female. Initial information was processed along with the additional information received on 22-JUN-2021. The patient's weight was 115 pounds, and height was 66 inches. The patient's concurrent conditions included nonsmoker, and alcohol user (infrequently). Patient had no known allergies and had no drug abuse or illicit drug usage. No medications were used by the patient.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805205, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 to left arm at approximately 15:15 for prophylactic vaccination. Concomitant medications included aciclovir (occasionally). The patient had not taken it within the first few days of receiving the vaccine and she did not remember the exact dates of when she took it after.  On 16-MAR-2021, the patient experienced general malaise. She did blood work on 09-JUN-2021 and 11-JUN-2021, which showed no response to the spike protein antibody (confirmed immunological vaccine failure). On 09-JUN-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) as 3.24 AU/ml, Non-Reactive, Negative. On 11-JUN-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general malaise on 17-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000183695.; Sender's Comments: V0: 20210645526-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient complains of pain in left shoulder and arm (above the elbow) and also tingling sensation.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; PAIN IN EARS; SINUS INFECTION; ELEVATED LYMPH NODES; This spontaneous report received from a patient concerned a patient of unspecified age female. 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: 1805031 expiry: unknown) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that after receiving the vaccine patient contracted COVID-19 on first July (year not specified) (confirmed covid-19 infection and confirmed clinical vaccination failure). Patient did a rapid antigen test and her symptoms included body aches, several general headaches, cough, fever. All of the symptoms were resolved on fifth July (year not specified) except the sinus infection. Also had pain in ears and elevated lymph nodes. Patient had a virtual appointment with a Telo-doc physician on fifth July (year not specified) and was prescribed with antibiotics for a sinus infection. Patient had to call them back on 11 July (year not specified) since the medication not worked. Laboratory data (dates unspecified) included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and elevated lymph nodes, had not recovered from sinus infection, and the outcome of pain in ears and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0- 20220726291- covid-19 vaccine ad26.cov2.s Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
DEATH Narrative: PT WAS PLACED ON HOSPICE ON 1/21/2021
2-19-21: sore arm; 2-20-21 sore arm sniffles, sometimes tingling around mouth and on left side of face; 2-21 - tired, tingling along jaw line; 2-24-21 - sniffles,intense  tingliness on and under tongue, feeling of numb lips; 2-25-21 numb lips - called Facility, talked with advise nurse: 2-26-21 swollen gland, slight headache. Video visit with Dr,; She said if symptoms continued for another week to call back and that an MRI might be considered.  . Symptoms of tingling, sense of  numb lips primarily on left side have continued daily through today 3-5-21.  Called advise nurse today  and am waiting for a call back from Facility.
1015AM weakness, gen tremors;1025AM chest tightness, wheeze bilat upon auscultation, AR 100, irregular, R20;1030AM epi given 02;1030AM EMT called;1040AM lungs clear chest tightness gone to ER via amb;
pt recv vax 14NOV96 & began to run temp 102 or 105.2 began cont crying about 130PM-feel asleep a few hr later then woke up & cried >4hr-called to MD
pain in both sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, intramuscular, administered in arm left on 18Mar2021 as single dose for covid-19 immunisation. Medical history included parkinson. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization that was probably 25 years ago and experience sinus blocked. The patient experienced pain in both sore arm on 18Mar2021 with outcome of recovered on 20Mar2021.  Patient stated that she had a very sore arm in her left arm that occurred with the first dose of COVID vaccine and stated that the arm soreness started 3 or 4 hours after the vaccine and lasted about 2 days. No AE require a visit to emergency room nor physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The first day I had chills and numbness and tingling in my hands and feet, soreness in the injected arm. The second day I had bad muscle and joint pain in both legs. The third day I had extreme fatigue, my body and head felt heavy, brain fog, dizziness and nausea. The fourth day I was pretty much back to normal.
Chickenpox lesions began on 2/3/02 and by 2/12/02 had over 100 lesions. Some appeared infected. Rx'd Keflex 250 tid X 10 days. Received Varivax on 2/20/96.
I had a minor reaction on day 2-3 post-vaccine administration; minor arm pain, perhaps some fatigue. I took ibuprofen once at bedtime on day 2. No further discomfort . On day 8 post-vaccination, I woke up with the sensation that my arm was sore at the vaccine site. The same morning, looked at my arm and found it to be quite red in a 3-4 inch diameter irregular blotch surrounding the vaccine site. It was a bit redder at the edges, but fairly uniformly hot pink throughout. It itched a good bit. Some internet sleuthing (sorry!) revealed that the appearance and timing are consistent with what's being called 'covid arm'.  I took two doses of ibuprofen that day. The discomfort  was manageable and did not get worse. These symptoms subsided gradually and 7 days after onset, it appears completely resolved.
This spontaneous report as received from a medical assistant refers to a 8 months old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N029870, expiry date: 02-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868, US-009507513-1902USA009323:Original Case : 1902USA009323, US-009507513-1902USA009325:Original Case : 1902USA009323, US-009507513-1902USA009326:Original Case : 1902USA009323.