chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a stiff neck on my left side (the side I got my shots on); left elbow is sore / painful; not feeling so great; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 27Mar2021, outcome "not recovered", described as "developed a stiff neck on my left side (the side I got my shots on)"; ARTHRALGIA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "left elbow is sore / painful"; MALAISE (non-serious) with onset 27Mar2021, outcome "not recovered", described as "not feeling so great". Therapeutic measures were not taken as a result of musculoskeletal stiffness, arthralgia, malaise.  Additional Information: Facility type vaccine: Hospital. No other vaccine in four weeks. I developed a stiff neck on my left side (the side I got my shots on) after getting the first shot, it started to go away after 2 weeks. My left elbow is sore / painful ever since I got the shots. Unknown if covid prior vaccination. Unknown if covid tested post vaccination: Unknown. Known allergies: No. Other medical history: None.  Follow-up attempts are completed. No further information is expected.
A little over ab hour after receiving the vaccine I noticed a burning sensation in my sinuses. By 130am 1/1/2021 I awoke from my sleep terribly dizzy, shaking violently and experiencing a fever of 101.3 F. I took advil and tylenol and fell asleep about an hour later. I woke up with similar symptoms at approximately 830am on 1/1/2021 took an additional dose of advil and tylenol and slept till 12p. I woke up with a bad headache and coughing fits similar to when I had covid back in March. I went to an urgent care who assessed me and ordered me to the ER. medical center administered IV fluids, an inhaler, steroids, epinephrine and benadryl and a few hours later my symptoms had subsided for the most part and a dose of IV antibiotics was administered. I am currently admitted for observation with likely discharge on 1/2/2021.
Patient fainted immediately after administration of MMR vaccine, which was the 2nd vaccine administered. EMS was called, ambulance arrived, patient alert x 3. Vital signs taken by EMTs. Mother contacted to inform patient had fainted. Patient and mother both refused to be transported to be checked out via ambulance.
Information has been received from a doctor of pharmacy concerning a male patient, who on 08-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667690/1158Z). The pharmacist reported that on 08-FEB-2011 the patient developed local swelling after receiving PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
Over the course of a week, pt developed profound sensory loss and weakness of legs and bladder. Was hospitalized for several weeks and given treatment with steroids and IVIG. Pt has slowly recovered. Can now walk but still with sensory loss pain in legs. Still recovering.   The medical record received on 3/3/04 states transverse myelitis and anxiety. Annual follow up on 03/17/04: "The pt has not recovered from adverse events.  Still has numbness and tingling from toes up to hips. Feet range from completely "numb" to very painful.  Never have normal feeling in feet and legs.  Balance is "off" and cannot run. Must always watch feet, especially on stairs or uneven walkways. Still have no idea of "my space" in relation to feet and sometimes legs."
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "nonischemic cardiomyopathy" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "hypothyroid" (unspecified if ongoing); "former smoker" (unspecified if ongoing), notes: former smoker. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the events Drug ineffective and Covid-19 assessed as related to the suspect drug Comirnaty.
This spontaneous report as received from a medical assistant, refers to a 59 year old female patient. Patient's concurrent conditions included high cholesterol, hyperthyroidism, asthma, depression, diabetes and gastrooesophageal reflux disease (GERD). Patient's medical history included following drug reactions: stomach upset after taking LEVAQUIN, sulfa and ampicillin; hyperactivity after SUDAFED; face swelling after dextromethorphan and MUCINEX; fever and unspecified severe local reaction after tetanus toxoid and unspecified reaction after taking lidocaine and iodine. On 19-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX via the intramuscular route in error (dose: 0.65 ml, lot # K011002, expiration date: 07-NOV-2015) in the left arm. Concomitant therapies included aspirin, EXCEDRIN MIGRAINE, simvastatin (manufacturer unknown), SINGULAIR, ranitidine, metformin, fluticasone propionate, levothyroxine sodium (manufacturer unknown), vitamin DC, budesonide, ipratropium bromide (manufacturer unknown), WELLBUTRIN, benzonatate, bupropion hydrochloride and ADVIL. The patient also used One Touch Ultra Test Strips, as directed, daily. On 20-JAN-2015, the patient experienced red, swollen, painful rash on the left upper arm (the same arm, where ZOSTAVAX had been injected). The patient sought medical attention-called the healthcare worker. BENADRYL was recommended by the healthcare worker, but was not started yet. The patient recovered on 24-JAN-2015. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
A legal complaint was received from an attorney regarding an adult white male. The decedent's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the mid 1950's, the decedent was administered OPV or IPV. Sometime on or about 1/01, the decedent was reportedly diagnosed with metastatic mesothelioma of the right lung. The legal complaint stated that the decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent including, but not limited to breathing difficulties, asbestos is, lung and/or other cancer, mesothelioma, and/or lung damage. On 1/20/03, he died from respiratory failure. Pulmonary embolism was indicated as another significant condition contributing to the death.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Other medical history: sleep apnea" (unspecified if ongoing), notes: Other medical history: cervical radiculopathy; "Other medical history: cervical radiculopathy" (unspecified if ongoing), notes: Other medical history: cervical radiculopathy. Concomitant medication(s) included: TELMISARTAN oral, start date: 01Sep2022; AMLODIPINE oral, start date: 01Sep2022. Past drug history included: Quinolones, reaction(s): "Known allergies: Quinolones", notes: Known allergies: Quinolones. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment of COVID-19 with Paxlovid, via Oral, treatment start date reported as 28Jan2023 and stop date reported as 01Feb2023.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the use of suspect product cannot be fully excluded.
pt recv vax 11JUN97 & 12JUN97 vomit, t102, irritable, local pain & swelling the vomit, resolved & fever resolved w/in 24-36hr leaving a residula large 17-8cm;sterile abscess
Patient got flu vaccine first then she got covid 19 bivalent vaccine and she passed out for few seconds then she passed out second time and had minor seizures like symptoms. I had to call 911 and paramedics took her vitals and they were normal.
I rec'd my first Covid vaccine shot on 3/3/21 in my right arm.  I had soreness in the arm for 2 days afterwards.  On Wednesday, March 10, 2021, I got severe pain behind my left ear and down the left side of my neck.  Saturday morning, March 13,2021 my lips were numb and I was not blinking my left eye and I could not close my left eye.  I went to the doctor Monday morning, March 15,2021 and she confirmed Bell's Palsy.  Blood was drawn and I was given prescription medication.
WEIRD TASTE IN MOUTH AND SWOLLEN LYMPH NODE IN LEFT ARMPIT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Generalized anxiety disorder and arthritis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2 SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 24Oct2023 to 28Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
9/1/21: Patient arrived at the ER after being found on the floor by a friend. Patient was confused, not cooperating and not answering questions.  Laboratories are remarkable for positive COVID-19 test, uremia, hypercalcemia, hypernatremia and acute renal failure.  She was started on IV fluids, oxygen supplementation, Decadron and Cardizem drip.
Patient is an 80 yo female with a history of small cell pancreatic and lung cancer currently on chemotherapy, tobacco dependence, emphysema, generalized anxiety disorder, abdominal aortic aneurysm, restless leg syndrome, secondary polycythemia, HLD, HTN, carotid artery stenosis, hypercalcemia, who presented to the ED complaining of hypoxia at home, at 85% on 8/21/21. She does not use oxygen at home. Patient is fully vaccinated with Moderna in February 2021. She was diagnosed with COVID on 8/17/21. She had no prior diagnosis of COVID.  She complains of scratchy throat and diarrhea; however, no SOB, fever/chills, loss of sense of taste or smell, abdominal pain. Patient is currently on 4L. CXR on 8/17/21 showed patchy airspace disease in both lungs. CXR on 8/21/21 showed mild worsening of multifocal pneumonia. CTA chest showed no evidence of pulmonary embolus. Stable right lower lobe mass. Stable midlung nodule. Interval new bilateral peripheral patchy but extensive infiltrates consistent with atypical/viral pneumonitis. Tiny right pleural effusion. Multiple mediastinal and hilar lymph nodes show interval increase in size. Laboratory values revealed pancytopenia, hyponatremia, and hypokalemia.  She was started on remdesivir and dexamethasone.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 15 patients who experienced complained of having itchy and rashes at injection site, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. The patient developed a non-serious complained of having itchy (pruritus) following the administration of INFLUENZA VACCINE. The patient developed a non-serious rashes at injection site (injection site rash) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab test.) Final diagnosis was rashes at injection site and complained of having itchy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for complained of having itchy and as Unknown for rashes at injection site.
Cramp; redness / redness at the injection site; soreness; vomiting; flu like symptoms; fever; chills; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle reaction in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 24th July 2019, immediately after receiving Shingrix, the patient experienced injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms. On an unknown date, the outcome of the injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site muscle reaction, fever, chills, nausea, headache, injection site erythema, pain in arm, vomiting and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. Shortly after getting the vaccine the patient got a cramp feeling in the muscle where she received the vaccine. In the middle of the night patient started having fever, chills, nausea, headache and a sore arm and redness at the injection site.  The patient also vomited a couple times. The flu like symptoms lasted 5-6 days.  Around the time that the flu-like symptoms resolved, the redness started moving down her arm towards her elbow and her arm continued to be sore.  The redness eventually resolved a few days ago, but her arm was still sore, 19 days after getting the vaccine. The patient still having side effects from first Shingrix shot, and did not know what to do. The patient hesitant to get the second one, and did not know when the side effects would go away from the first one, and why did she get them so badly when average duration for side effects was two to three days. The reporter consented to follow up.
In bed since getting the vaccine; weakness in their legs; little pain under their right breas; feel worse than when having chemo; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, FATIGUE (In bed since getting the vaccine), ASTHENIA (weakness in their legs), BREAST PAIN (little pain under their right breas), MALAISE (feel worse than when having chemo), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol and Advil.; 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.
light discharge from my vagina; breast seemed to become enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (07Feb2022), this case now contains all required information to be considered valid.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EN6207) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney absent", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law; "Laparoscopic surgery", start date: 02Nov2020, stop date: 02Nov2020, notes: Donated my right kidney to my brother in law. Laparoscopic surgery successful procedure.; "Foot surgery", start date: 11Sep2020, stop date: 11Sep2020, notes: Hit on foot by a pickup truck on 30Nov2019.; "Kienbock disease" (unspecified if ongoing), notes: Kienbock disease drought on by being hit by a truck. Surgery was successful.; "ADD" (ongoing). There were no concomitant medications. The following information was reported: VAGINAL DISCHARGE (non-serious) with onset Nov2021, outcome "unknown", described as "light discharge from my vagina"; BREAST ENLARGEMENT (non-serious) with onset Nov2021, outcome "unknown", described as "breast seemed to become enlarged". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received dose 2 on 17Dec2021 Approx 1 PM, Anatomical site of injection: Left arm, Batch/Lot number: 33030BD.Vaccination facility type: Pharmacy or Drug store.  No follow-up attempts are possible. No further information is expected.
Swollen Lymph node (Left side of the neck) Muscular fatigue (arms and legs0
After receiving the shot he experienced light cold, tiredness; After receiving the shot he experienced light cold, tiredness; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever; his head is a little down, heart and lungs feels like there's something in it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 04Apr2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient reported he got his first dose on 04Apr2021 and he experienced light cold, tiredness, but the second day those adverse event got away, however in the beginning of the second week after he got the shot adverse events started to happen again, his head is a little down, heart and lungs feels like there's something in it, difficulty breathing, felt drowsy muscle felt uncomfortable and had low fever. He wanted to know if that was normal or okay. The outcome of all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested.
immediately after receiving injection ,  became unresponsive with  severe drop in BP.  - quickly regained consciousness   given IV fluids and transferred to ED. EKG and chemistry normal. - No further intervention in ED. Observed for 3 hrs and d/c home
5 X 5 cm wheal at site of either PENTACEL or MMR.
Since end of June also noticing similar weakess/pain in both upper arms; severe muscle weakness; moderate pain at hip/thigh (NOT joint or arthritic pain); moderate pain at hip/thigh (NOT joint or arthritic pain);; Affects ability to walk (assistance or cane to help); This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6198), intramuscular, administered in Arm Left on 02Mar2021 11:45 (at the age of 67-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergies to tea tree oil and fragrances used in cosmetics/cleaning products, thyroiditis, non-specified atopic dermatitis. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3247), intramuscular, administered in Arm Left in Feb2021 12:00 as dose 1, single for covid-19 immunisation and experienced prolonged arrhythmia episodes starting after 1st dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021, (10 days after second shot) patient experienced severe muscle weakness and moderate pain at hip/thigh (NOT joint or arthritic pain), started in right side. After a couple of days, occurred in left side. Some overlap in both R/L and then resolved in right followed by the left. Duration was about 1 week. After a couple of weeks from resolution, occurred again, (both sides) eventually resolving. This AE was ongoing. Intervals of occurrence vary. Affects ability to walk (assistance or cane to help). Since end of June, patient also noticed similar weakness/pain in both upper arms. Serious criteria were reported as no. Treatment was not provided for adverse events. The outcome of events was not recovered.