chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from  a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M040271 with expiration date of 30-APR-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit (°F) for 30 minutes. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012690:
Moderate arm pain, chills, nausea, tiredness, low-grade fever - within 24 hours
Patient has a history of seizures. Patient received 2nd dose of Moderna Covid 19 vaccination. They did ok with the first vaccine. Approximately 5 minutes after receiving the vaccine the patient had a blank stare, which the caregiver noted and informed staff that patient was having a seizure. Within 30 seconds the patient was jerking, had clenched fists, and was not coherent. The caregiver was able to keep the patient in the chair and keep her from hitting her head. After jerking motions stopped the caregiver was able to contact the person responsible for medical decisions for patient and mother decided that she need to be taken to the hospital. EMS arrived and took patient to the hospital within 15 minutes after seizure. Patient was alert and oriented when EMS arrived.
Patient walked into the clinic this morning to report significant LEFT sided facial swelling. She denied any respiratory distress, difficulty swallowing or any other symptoms at that time. She states she noticed the swelling when she woke up this morning. She had not attempted any OTC medication prior to coming to the clinic. She was ordered to go to the ER for further evaluation and treatment.
Allergic Reaction- small bruise at injection site (left deltoid) , pain, swelling  from the site towards the elbow joint, skin hot to touch, skin redness
p/vax pt devel a lump in lt arm @ the inj site;pt reportedly was seen by several MD & finally had the lump removed surgically;pt stated the lump came back;pt was asked if ever exp trauma or an inj to this arm;
Atrial fibrillation; irregular heart beats; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant) and heartbeats irregular (Verbatim: irregular heart beats). The outcome of the atrial fibrillation and heartbeats irregular were resolved.   It was unknown if the reporter considered the atrial fibrillation and heartbeats irregular to be related to Arexvy.   It was unknown if the company considered the atrial fibrillation and heartbeats irregular to be related to Arexvy.   Additional Information: GSK receipt Date:09-NOV-2023 The patient self-reported this case. The patient age was in between 65-79 years old. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow up would not possible as no contact details were available.
pt recvd DTP/OPV/HIB @ approx 1630 on 28JAN93 approx 5 hrs later had 40-45 mins generalized, afebrile sz;
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELOXICAM for an unknown indication.   On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.). At the time of the report, PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. Patient took vaccination at vaccination facility, pharmacy.    This case was linked to MOD-2021-288132 (Patient Link).
chills; headache; tiredness; fever; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   In November 2019, the patient received the 1st dose of Shingrix. In November 2019, 10 hrs after receiving Shingrix, the patient experienced fever, chills, headache and tiredness. On an unknown date, the outcome of the fever, chills, headache and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. In November 2019 at 3.00 pm, the patient received the 1st dose of Shingrix. In November 2019 at 1.00am , the patient experienced adverse reactions. The adverse events lasted 48 hours. The reporter consent to follow up.
Became ill  2 month later  after vaccination developed chills nausea dizzy and short of breath next day diarrhea . Out of work for 3 days.  Blood pressure elevated.
This spontaneous case initially received on 31-Jan-2017, was reported by a Non-Health Professional and concerns a(n) 70-year-old male patient. Weight: not provided; Height: not provided Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA for Flu vaccination from 12-JAN-2017 to 12-JAN-2017 Dose regimen: Not reported, Route of administration: Not Reported. Batch number: 14049222A. No additional suspect drugs. Adverse reactions/events and outcome: On 12-Jan-2017, immediately after administration, the patient acquired a big welt on his arm. Ice was used on the reaction site and the swelling subsided that day before the patient left the clinic.
PT REFUSED EPI-PEN IF NECESSARY DUE TO A HEART CONDITION SO I EXPLAINED IF ANY SERIOUS REACTION OCCURRED THAT I WOULD HAVE TO CALL EMS. IMMEDIATELY AFTER BOTH IMMUNIZATIONS, PATIENT'S HEAD FELL BACK AND HER EYES ROLLED BACK, HER UPPER BODY AND HANDS TREMBLED. SHE WAS IN AND OUT OF CONSCIOUSNESS FOR ABOUT 5 MINUTES BEFORE EMT AND AMBULANCE ARRIVED TO ACCESS PATIENT. SHE REFUSED TREATMENT DESPITE UNSTABLE HYPOTENSION AND BRADYCARDIA WITH CLAMMY SKIN. SHE WAS RELEASED TO HER SISTER WITH ASSISTANCE BY EMT AS SHE WAS UNABLE TO STAND OR WALK BY HERSELF DUE TO HYPOTENSIVE EVENT. I CALLED HER THE NEXT DAY AT HOME AND SHE STATED SHE WAS FEELIMG BETTER AND WAS SORRY FOR RUINING MY DAY. I EXPLAINED IN NO WAY DID SHE RUIN MY DAY AND THAT I AM ONLY CONCERNED WITH HER AND HER HEALTH AND NOT MYSELF.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 1, 2 / Pfizer, Dose: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 040AZ1A), in right arm and on 04Apr2021 as dose 2, single (Lot number: 008B21-24), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "in remission from breast cancer (IDC - Triple Positive)" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "not recovered", described as "Moderna, Dose: 1, 2 / Pfizer, Dose: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 31Aug2023 to 04Sep2023.
On the second day, by the afternoon, there was quite a bit of pain and 3 inches below the site of the injection, a hot, burning lump appx 4 inches long by 2.5 inches wide developed accompanied by redness and throbbing pain and general soreness
Right arm has been hurting, whole arm is in pain, , the pain is not constant it comes and go; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm has been hurting, whole arm is in pain, , the pain is not constant it comes and go) in a 55-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A5716AB) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jan-2023, the patient experienced VACCINATION SITE PAIN (Right arm has been hurting, whole arm is in pain, , the pain is not constant it comes and go). At the time of the report, VACCINATION SITE PAIN (Right arm has been hurting, whole arm is in pain, the pain is not constant it comes and go) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication were reported. No treatment details were reported.
pt recv vax & an ELISA test revealed a negative titer 0.39;No further details were provided;
One week after injection---red, slightly raised, patch, approximately 2 x2 inches, at the injection site.  Very itchy.  Don't know if it will get larger.
Arm was sore the next day on the 9th after the 2nd vaccine but starting on the 3rd and 4th day the soreness increased and certain movement and particular simple movements had sharp pain in the shot area.   It hurts to lift arm.   It feels like I tore something at the vaccination area.
Pfizer monovalent is given to patient instead of Bivalent as requeted.  Patient does not experience any symptoms or side effect the day after.
Pt requested to get Hep B and Flu vaccine at same visit. After vaccines were administered within few minutes, she fainted. Pt was helped by RPH, store manager. Her blood pressure was checked, also heart rate, pt refused to go to ER. Pt was contacted afterwards. She said she is fine but she was scared from the needle. Pt denied any allergy or allergic Rxns to drug/vaccine. Clinical district manager was contacted as well.
20 minutes after vaccination, patient felt light headed and dizzy.  Returned to clinic for treatment.
Information has been received from a medical assistant referring to a 1 month old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M036156 with expiration date 23-FEB-2019, 1 dose, strength unknown) intramuscularly for prophylaxis. The vaccine was exposured at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. No adverse effect was reported. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1712USA005651: US-009507513-1712USA005650: US-009507513-1712USA005649.
Received Moderna vaccines on 3/5/21 and 3/31/21. On 5/6/21, patient developed blurred vision, 5/7 diplopia, 5/9 slurred speech and gait imbalance. Presented to ER on 5/9, CT/CTA head and neck negative. 5/9/21 MRI brain showed enhancing 1cm lesion with edema in right midbrain. Started on dexamethasone. 5/13 seen by neurology, no improvement in symptoms. 5/17 symptoms improving. 5/25 LP showed normal wbc, rbc, protein (53), elevated glucose (107), no oligoclonal bands, cytology neg. 9/9/21 MRI showed resolution of lesion with slight signal abnormality in right midbrain but no enhancement. Neuro exam om 9/20/21 normal
SHIN PAIN, BODY ACHES, NIGHT SWEATS, LEFT UNDERARM PAIN, FATIGUE
This spontaneous report was received from a registered nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ orally (therapy type digital data logger) (lot # L035511, expiry date 21-MAY-2017) dosing details was unknown. Concomitant medications were not reported. The vaccine was subjected to temperature of 65.9F for a time frame of 4 hours and 20 minutes. It was reported that the vaccine was administered, since there was a previously reported excursion, with a temperature excursion of 54.9F for 3 hours. Product quality complaint was not filed. No adverse effects were reported. This is one of the three reports received from the same reporter (MARRS #1605USA012070 and 1606USA000382). Additional information is not expected because the primary reporter did not want to be contacted.
COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am and complained that the injection was delivered too high and she was experiencing pain at the site. Vaccine placed high on L shoulder, just below acromion process, at or above humeral head. Seemingly placed between acromion process and humeral head, near or in soft tissue/bursa. Site pain is inflammatory in nature and does not seem to affect muscles, but instead is contained within joint itself.
10-17/15- Arm is sore, red inflamed, hot to the touch area about 2 inches below site of shot. 10/1815 - Area is still sore, red and inflamed.
Patient did not have a reaction, but was erroneously given a booster only two and a half months after finishing her primary series.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales Representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness, redness, blue and black color at the injection site on an unspecified date. Patient applied ice pack at the injection site and patient was doing well. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
Breakthrough COVID case: The patient is a 76 y.o. female who presents for evaluation of Vomiting diarrhea.  Patient with onset of symptoms last night with nausea, vomiting and diarrhea.  She had 2 episodes of diarrhea and more than 10 episodes of vomiting.  Is nonbloody nonbilious.  She has had some runny nose, cough and low-grade fever.  She is vaccinated for COVID-19 and had a booster as well.  She does not have any chest pain, abdominal pain, shortness of breath, headache or neck pain.  She has not had any dysuria or hematuria.  She states she is very thirsty at this time.  There are no other modifying factors or associated symptoms.
Patient got pale and felt faint. He felt nauseated. He asked to lay down. I assisted him to a lying position. I checked his vital signs and had him lay down for about 15 minutes until he felt better and color returned. His vitals remained stable. He never lost consciousness.
minor blood clot on his leg; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 03Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient had the first dose on 03Apr2021 and he was scheduled on Saturday 24Apr2021 to get the second dose of the vaccine. However, the patient had a minor blood clot on his leg, and he was taking blood thinners. Patient asked if it was okay to get the vaccine while talking to the blood thinners (as reported). The outcome of the event was unknown.  Information about lot/batch number has been requested.
DOD call received from patient on 11/2/04 No problems with first three ANTHRAX vaccines 10/09/03 - received anthrax vaccine #4 (foreign country)- no problems 11/03 - "early Nov 2003," noticed RLQ abd numbness - which spread to LLQ then to bilat upper quads and to epigastric area - aggravated with sitting-alleviated with walking 2/04 - above sxs worsened - c/o constant stabbing pain around the rib cage area - unable to sit or stand - seen by PCM - was given IBUPROFEN 4/04 - above sxs worsened - noticed "crawling" sensation and pain of bilat flank and lateral abd wall - "it felt like someone was beating me with a pipe on my kidneys" - abd CT (r/o cholecystitis) "normal except for kidney stone" (results not available) - seen by nephrologist - was given dx of renal lithlasis - no treatment given - "will watch it" 4/27/04 - ANTHRAX vaccine #5 5/04 - started noticing "muscle twitches" and spasms - initially localized to right calf - spread to "all over my body" - also c/o right hip pain lyme test positive - subsequent western blot x2 negative - neuro (military) suggests lyme disease despite neg western blot - was placed on Doxy bid x2 mos as recommended by neuro - pt. obtained "second opinion" from infectious disease specialist - was told "unsure" - Infectious disease consult and Westeren Blot not confirmatory for its dx - above sensory sxs resolved after taking doxy - no further treatment after the oral doxy 5/11/04 - thoracic MRI - Unremarkable MRI of the thoracic spine 5/13/04 - lumbar MRI - Mild disc bulge at L4-L5 with a left lateral focal annular tear - There is associated mild bilateral neural foraminal stenosis at this level 6/04 - was started on TRILEPTAL 6/18/04 - brain MRI - MRI of the brain is normal 07/07/04 - MRI right hip - 8/04 - obtained new neurologist (civilian) Repeat brain MRI negative 8/10/04 Nerve conduction and EMG - Normal electrodiagnostic study no ALS or motor neuron dysfunction/disease, no neuropathy, no radlculopathy DX: Benign fasciculation/cramping syndrome 11/4/04 Cervical MRI - Degenerative disc disease at the C5-6 and C6-7 levels 1/05 had sleep study done on 1/10 and muscle biopsy on 1/13 - both results pending at time - states most current dx is "muscle cramp syndrome" States feeling "better than before" however cont to c/o persistent pain and muscle spasms - "but I can and will deal with it" - pt. scheduled to leave out of country on 3/22/05 for 3 years Med record release form sent - no documentation received thus far.
pt in clinic 2 days post inject upper arm is warm to the touch; THere is an edematous, red area over rt deltoid aprpox 2 1/2 inches diameter;
Pt recv vax on 3/27/98; on 3/29/98 pt became cranky, irritable, inconsolable (not herself), blood stains in pt diaper &stool.  Pt imp 1 wk.
Patient stated that on Saturday (8-29-09) she felt fever, chills, swelling and pain from her left arm to her left arm pit, seen by doctor - Cephalexin 500mg by mouth every 6 hours and Ibuprofen 400mg by mouth every 6 hours with food Rx given
Patient was inadvertently given an adult dose of Hepatitis A vaccine instead of a pediatric dose.
tenderness at the injection site; a little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (a little bit of fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03814211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included IBUPROFEN, GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (a little bit of fatigue). On 13-Mar-2021, VACCINATION SITE PAIN (tenderness at the injection site) had resolved. On 14-Mar-2021, FATIGUE (a little bit of fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications included Vitamins.
3/2/2021 10:45 - got vaccine Instantaneously burning and shooting pain starting at injection point and radiating down arm and up arm to my upper back/neck 10:50 - tingling sensation around and in mouth 11:00 - Left observation area and went home  11:30 - burning sensation getting worse in arm  12:00 PM - throat beginning to tingle and harder to swallow 2:00 - one hive formed on right side of face, one behind right ear, and one on my labia. Throat tingling more and harder to swallow. Throat is much more red from what I could see. My Mother noticed my eyes getting puffy.  3:00 - shooting/burning pain in arm subsiding 4:30 - throat tingling subsiding  4:35 - arm soreness (which I expected) 5:00 - severe nausea and abdominal cramps. Had to sit in bathroom in case I threw up. Took Dramamine 6:00 - nausea and abdominal cramps gone. Most all symptoms are gone 10:00 - took Benadryl (only time I took it) and went to sleep  3/3/2021 8:00 - arm is too sore to move up and down 11:30 - fever starting (my normal baseline is 97 and my temperature was at 99 F at this point) 12:00 - fever to 100 and overall body aches (was expecting) 1:30 - took Tylenol  2:00 - fever and body aches subsiding  9:00 - beyond arm soreness, no other symptoms
Nausea started around 6/7 p.m. and continued throughout the night. Fever that lasted around 4 hours roughly, broke around midnight and was up the rest of the night sleeping maybe 20 minutes at a time. Didn?t feel tired.  Had headache and jaw/cheek pain in the morning. Took Motrin around 10 a.m. headache and jaw/cheek pain went away. Nauseous all day 2/6 ate toast in morning had small dinner- no big appetite.  Really sore arm, almost feels bruised and hurts to move. Moved arm a lot after vaccine. Hurts a lot more than first vaccine.