chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WORST SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned multiple patients.  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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced worst side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worst side effects was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2022 at 10:45 as dose number unknown, single (Lot number: G149693) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible. No further information is expected.
While administering Immunizations, used finger instead of table to put safety guard on the needle. Needle stuck left pointer finger. Unsure of  which vaccination was given during incident. I listed them both.; This report was identified from a line listing obtained on request by the Company from the Food And Drug Administration (FDA) under the Act.  This spontaneous report was received from a health professional referring to a 17-year-old female patient. It was unknown if she had previous allergies to medications, food, and it was not reported if she had other Illnesses at the time of vaccination or if she had chronic or longstanding health conditions. Her concomitant medications included drospirenone, ethinyl estradiol (YAZ) as birth control, diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL), poliovirus vaccine inactivated (vero) (IPOL), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX).         On 23-MAY-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number R021633, expiration date not reported, but upon internal validation established as 08-MAY-2021) and second dose hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number R007212, expiration date not reported, but upon internal validation established as 04-NOV-2020) both by intramuscular route in the right arm as prophylaxis (concentrations were not reported)  On 23-MAY-2019, while administered Immunizations, used the finger instead of table to put safety guard on the needle. Needle stuck left pointer finger. It was unknown  which vaccination was given during incident (injury associated with device). The patient had a blood drawn, however the results were not provided.  At the time of this report, the outcome of injury associated with device was reported as recovered.    The causality assessment between the suspect therapies and the aforementioned event was not reported.  As of 21-AUG-2020, an inbound call was received from a nurse, who stated that she was unable to identify the patient and therefor was unable to answer the questions on the form.
Severe nerve pain in sole of right foot out of the blue with no injury or other warning or prior pain or injury. Nerve pain spread up right leg to thigh.  Unable to walk or put any weight on foot/leg..  X-ray was unremarkable.
she passed away less than 24 hrs; This is a spontaneous report from a contactable consumer (patient parent). A 28-year-old female patient (daughter) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Oct2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer reported that her 28 year old daughter received her 2nd pfizer vaccine dose on 15Oct2021 and she passed away less than 24 hrs. The medical examiner was conducting a thorough review. The patient died on 16Oct2021. An autopsy was performed and results were not available.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away less than 24 hrs
This initial non-serious spontaneous case, was received on 13-Oct-2017, from a pharmacist, concerning a 28-year-old adult male patient. The patient had no medical history and took no concomitant medications. On 04-Oct-2017, the patient was administered with the FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: left deltoid, batch number: 195227, expiry date: May-2018). It was reported that the patient was administered with a dose less than 0.5 ml, as some dose came out through the lock attached. The pharmacist wore gloves and hence, was not exposed to the vaccine. The patient was administered with a second dose of vaccine. No adverse events had occurred. It was reported that the defect was discovered during the use. Hence, full dose of vaccine was not administered. The location of the leak was from the bottom where the lure lock attaches. There were no signs of damage on the syringe. The model of the needle used was BD/25 gauge/1 inch. The needle appeared tightly attached. As per PTC (product technical complaint) (PTC number: 1025258) investigation, it was concluded that FLUCELVAX Batch 195227 was manufactured in compliance with approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for leaking syringes. The most likely root cause could be attributed to no internal root cause could be confirmed and no external/user root cause could be determined. Significant case correction received with IRD 13-Oct-2017: Event 'drug administration error' was removed from the event field. PTC (PTC reference number: 1025258) report received on 13-Oct-2017: It was reported that the defect was discovered during use. Hence, full dose of vaccine was not administered. The location of the leak was from the bottom where the lure lock attaches. There were no signs of damage on the syringe. The model of the needle used was BD/25 gauge/1 inch. The needle appeared tightly attached. The narrative was amended accordingly. Significant case correction received with IRD 13-Oct-2017: Event 'drug administration error' was removed from the event field. Follow up received on 01-Dec-2017: The PTC investigation results were updated. The event "no adverse event" was deleted from the screen. The narrative was amended accordingly.
Patient states she began with pain and numbness in the injection site a few minutes after administration. Around 5:00pm she began with stomache pain and nausea which lead to various vomits.
Left arm is red, raised, and warm at injection sites.  One site has 2 small blisters at injection site.
This spontaneous report was received from a pharmacist referring to a 66 year old male patient. The patient's medical history and concurrent conditions were not reported. On 12-OCT-2017, the patient was vaccinated with one dose of PNEUMOVAX 23, (lot # N022703, expiry date 27-FEB-2019) intramuscular for prevention of pneumonia. A couple of weeks ago the patient received a dose of influenza virus vaccine and a dose of PREVNAR 13. On 12-OCT-2017, approximately 10 minutes after vaccination, the patient felt shaky (tremor), and began experiencing pain all over his body. The staff had to assist the patient to sit down in the front of the store. No treatment was given to the patient at the time of reporting. The outcome of tremor and pain was reported as not recovered/not resolved. No causality assessment between the events and the PNEUMOVAX 23 therapy was provided by the reporter.
6PM pt began to get glazy eyed; & warm to touch @ 750PM t104.6 ax then was given APAP between 630-830; began to notice inc resp rate; legs & arms began to jerk like in spasm; incontinent; t102.6-103; restless noc;
Deltoid pain, prolonged without initial reaction, just musc pain present still 12/22/15, but improved Tx with po ibuprofen US and lab w/u (-).
small red rash; most of the upper-arm is now itchy; baseball size bump; arm is numb; tingly; rash; fever; small red bump; achy and it lasted few days; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy) and SWELLING (baseball size bump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH (rash) and PYREXIA (fever). On 28-Mar-2021, the patient experienced RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy), SWELLING (baseball size bump), HYPOAESTHESIA (arm is numb) and PARAESTHESIA (tingly). At the time of the report, INFLAMMATION (small red bump), PAIN (achy and it lasted few days), RASH ERYTHEMATOUS (small red rash), PRURITUS (most of the upper-arm is now itchy), SWELLING (baseball size bump), HYPOAESTHESIA (arm is numb), PARAESTHESIA (tingly), RASH (rash) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment includes ice pack
Information regarding a polio vaccine was received from an attorney regarding a male patient who received a dose in the early to mid 1960s. The patient has a past history of chemical poisoning. He was reportedly exposed to asbestos and asbestos-containing products. He has a past history of smoking for 20 years. Indication for the polio vaccine was immunization. Product was administered on an unspecified date in the early to mid 1960s. Concomitant medications were not reported. According to the legal complaint, the plaintiff was diagnosed with malignant Mesothelioma in June 2003 and metastasis in July 2003. His symptoms began gradually; however, the plaintiff believes that these symptoms began around October 2002. Reportedly the plaintiff received a polio vaccination in the early to mid 1960s...that was contaminated with SV 40 virus which was a substantial factor, and therefore a cause of the plaintiff's mesothelioma. The legal complaint states that the plaintiff's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. Medical records are on file.
Patient had an appointment 5/3/23at 4:30 pm to get her 2nd dose of HPV. Instead, clinic gave her Hep B vaccine for adults per the registry.  I asked for facility to give me something in writing and would like you to report this to the health department as medical negligence. Dr spoke with patient and I and said, " there last 5 patients had the Hep B vaccine and it was a simple mistake."  This is really unbelievable and needs to be reported to the state health department. Patient' s medical record and someone gave her the wrong vaccine. Now patient is supposed to go next Wednesday. We have a follow up visit 5/10/223 at 04:30 pm for pt to hopefully be given the correct vaccine HPV 2nd dose. I don't know why safety protocols aren't being followed at this doctor's office in giving kids the correct vaccine. I spoke to the office manager.
Developed rash on her arm at the site of vaccine administration 6 days after vaccination, has not had pain nor itching associated with the rash.
Rash on back and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2022SA015261. A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation; dupilumab (DUPIXENT), from 03Dec2021 (Batch/Lot number: unknown) to 03Dec2021 at 400 mg 1x/day. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 10Dec2021, outcome "unknown", described as "Rash on back and legs". The action taken for dupilumab was unknown. Additional information  Initial information received on 12Jan2022 regarding an unsolicited valid non-serious case. Pfizer BioNTech COVID-19 Vaccine, Suspect Generic Name: Tozinameran, with an unknown dosage regimen, route, strength, formulation and strength unknown. Dupixent, Substance Name: Dupilumab Suspect, Device constituent associated with drug Dupilumab pre-filled syringe, Formulation: Solution for injection, Strength: 200 mg, Combination product or not: Yes, Add constituent devices in case for assessment: No, Duration of administration: 1 day route and formulation for an unknown indication. The patients past medical history, medical history treatment(s), concomitant(s) and family history were not provided. The patient who had (rash on back and legs while being treated with Dupilumab (Dupixent) via unknown medical device and Tozinameran (Pfizer BioNTech COVID-19 Vaccine). On 10Dec2021 the patient developed a non-serious event rash on back and legs (rash) (latency: 7 days) following the first dose intake of Dupilumab and (latency: approximately 6 hours) following the first dose intake of Tozinameran. It was reported "received her first dose of 400mg of Dupixent on 03Dec. On 10Dec she got her first Covid shot and 5-6 hours later she developed a rash on her back and legs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed erythema, papular rash on face and bridge of nose 3 weeks post vax. Pt was treated with topical steroids. Rash has improved, but still present after 5 months. Pt now has papular, scaly, erythematous rash on elbows and knees. Elevated CPK (446) mildly elevated ANA 1.80
6/13/2022 mild sore throat and mild cough. Tested on 6/15 at home rapid antigen COVID 19 test, positive. Tele visit on 6/15, was prescribed PAXLOVID. Day 4 of PAXLOVID treatment, 6/19 symptoms cleared up, but returned after the course of PAXLOVID ended on 6/21. 7/3 tested negative.
Patient woke up approximately 15 hours later after vaccine was given with facial swelling and hives
Extreme shivering and feeling of freezing temp even in hot shower. legs and knees ached very painfully, headache, nausea, vomiting, diarrhea, sweating, fever at 100 degrees, full body aches and felt very restless. Not able to sleep well. Symptoms lasted until 2/7/2021 @ 1200pm. Worse than reaction to 1st dose.
Dizziness began 2nd day after booster at approx 3am-woke me up from sleep; difficulty returning to sleep Nausea began at the same, No vomiting, loss of appetite continues to the time of this report *Note: patient did not experience any sides effects, including those listed here, from previous 3 Covid Vaccine injections
PT has red irritating patches along both arms and across his shoulders. Pt states they are itchy and Benadryl hasn't helped.
30 mins after subcutaneous vaccine was administered into patient's right thigh area, mother returned to practice stating the site was red & swollen.  By the site of the Varivax injection there was a one inch red spot with heat and a lump within the swollen area.  Patient felt pain with slight touch.  A cold pack was given and applied to site.  Benadryl was given.  Called mother 3 hours later and mother stated that the redness had subsided.  At 24 and 48 hours after vaccine, patient's mother reported that patient had extreme fatigue and muscle weakness with fever.
5/12/15 (received vaccine)-lump/knot at injection site, 5/13/15-headache, mental disorientation/trouble remembering things 5/17/2015-small, red, itchy rash appears-quickly spreads to cover whole upper left arm. Very painful when touched 5/19/15-evaluated at PCP office, using triamcinolone cream per patient, rash, itchiness has resolved.
W/IN 24 hr PT EXP SX OF INFLUENZA; SEVER H/A;PHOTOPHOBIA;POLYMYALGIA;MALAISE;3 wk LATER EXP PULMONARY SX W/ DRY THEN PRODUCTIVE COUGH. SX PERSIST. EOSINOPHIL COUNT 21% @ NORMAL DIFFERENTIAL
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 17 years old adolescent patient and unkonwn gender. On 16-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
pt devel ache-low grade fever lasted about a week-rash broke out on buttocks;saw MD CBC showed white count 30K, 4 days later  60K;
Very sore arm, swollen lymph nodes, severe chills, muscle aches and pains in back and legs, slight headache.
Patient reported no adverse symptoms at this time.  We were processing the immunization to the insurance after the event and noticed the error.
Small papular bumps with itching on both arms at sites of MMR and Varicella vaccines, and across abdomen and back. Treated 6/15/15 with depomedrol injection and prednisone PO.
I called my insurance provider's RN hotline at the onset of dizziness, which was then followed by a bout of ear ringing and nausea. I was advised to seek immediate medical attention, so I had an RA at my university dorm walk with me across the street to M Health Fairview hospital. I was seen by an RN in their emergency room, but was ultimately never seen by a Doctor as I did not present a clear risk of anaphylaxis at the time. After waiting in the ER for four hours for medical care, I ultimately left because most of my symptoms subsided. My most lasting symptoms cleared up late yesterday (1/25) and they were extreme soreness/tenderness at injection site and fatigue.
No additional AEs were reported; 19 year old received a dose of PROQUAD; This spontaneous report was received from a physician referring to a 19-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and previous drug reactions or allergies was not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   On 02-AUG-2022, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
She fainted and has a seizure. Dr. was present and she had other Drs. support with all the office staff (Nurses). They help her to recover and provide Pedialyte and gummy bears. Sha was pale and took some time to recover. Due to the fall she hurt her right wrist.
Rash broke out on the upper left arm.    The rash was approximately 4 to 5 inches.  Very, very warm to the touch. Went to Med facility on 6/7/2021.  Was prescribed the following meds:  10 mg Loratadine, 500 Cephalexin, 20 mg Prednisone.  Apply warm compress.  Rash eventually went away by the time meds were done.
Moderate joint pain; muscle pain; tiredness; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0179 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 07May2021 as dose 1, single (at the age of 38-years-old) for COVID-19 immunization. Medical history included inflammation, obesity, pollen allergy and COVID-19 (prior to vaccination) from unknown date to unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications included paracetamol (Tylenol) and Zurtec. On 11May2021, patient had moderate joint pain, muscle pain and tiredness, included big toe, thumbs, underarm, neck and pelvic/leg area. Patient received no treatment for the events. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
pt recv vax; had varicella disease w/ hundreds of lesions; started 7 days p/ vax;
At first, my left arm was incredibly sore.  Then it became swollen, very red and hot.  This area expanded to almost below my elbow for five days, then, I had diarrhea for seven days.  It was extreme in that it was like having a colonoscopy prep every day.  I am not prone to diarrhea, normally.  This continued, even after multiple Immodium tablets each day.  My feces was bright yellow, loose and had I a lot of gas.  It is February 9th and I am still having some intestinal distress, but, it is not as bad.  I have not been eating much, as everything I eat seems to bring it on.  I have not sought treatment, as I don't have any money to do that.  I sort of self-treated.    I did not have a fever at any time.
Pt was in clinic with younger sister to obtain vaccines. Nurse obtained vaccines for the four old sister to be administered which included DTaP. Pt only needed HepA. Mother preferred that the four year old sister recieve HepA only. Pt was given DTaP instead of HepA.
Within 24 hours of I2s administered on 7/3/08, pt c/o pain in elbows when fully extended & fully flexed.  No local reaction, no fever; L arm improving moreso than R arm; will try ADVIL & if symptoms persist parent instructed to call back; no family members ill; pt. does not c/o arthralgias in other joints.