chrisvoncsefalvay/vaers-outcomes huggingface dataset:
paralyzed; This is a spontaneous report from a contactable consumer reporting for a patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter interviewed a woman who said she was paralyzed on an unspecified date after receiving the second dose of the Pfizer vaccine. The reporter mentioned they understood this is incredibly rare, and this has not been confirmed to have a connection to the vaccine, but would like to include a statement from Pfizer on these claims. The event outcome was unknown.  Information on the lot/batch number has been requested.
Patient complained of tingling in lower arm 2 hours after Td was administered. No edema or redness at site. Neurologicaly intact.
At 4 months shots PEDIARIX, PCV13, HIB, rotavirus she developed a follicular rash on both thighs. It lasted a few days. No fevers, acted well. This week at 6 months shots, noted below identical rash both thighs, extending up to belly. No fever, decreased appetite, but exam otherwise well.
Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient mother was calling on behalf of her daughter who was 16 and was scheduled to get vaccinated today but she has a sore throat and they don't know if she can get the vaccine today or if they will have to reschedule it. Agent said the caller was reporting that her daughter had test for COVID-19 yesterday that was negative, and she got first dose of the Pfizer COVID-19 vaccine on the 8Apr. Dates for sore throat was unspecified. Reporter seriousness for COVID-19 vaccination was unspecified. She says she just wants to know, can her daughter take the shot if her throat is hurt or do they need to reschedule.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is 16 years old, but received the booster dose of 0.2mL, instead of 0.3mL that she should have
DTaP given in (L) arm, pt very anxious & agitated - 6-27-12. Raised red 2 1/2" x 3" to (L) - arm swollen site. Seen in office 6-28-12 with above noted.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), on 23Nov2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diet control DM" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: metal" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: statins, reaction(s): "Known allergies: Statins". The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 20May2023 to 24May2023.  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 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 comirnaty cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300208928 same patient, different drug, different event;
after vax pt exp on lt leg raised red area, hard area, hot to touch, c/o itching,  on 5/6 m.d. said it was an allergic react. health nurse saw 5/12 circular raised area, skin dark, c/o itching.
Initial unsolicited misuse report received from a physician on 23 May 2016. This case involves a six-year-old male patient who was vaccinated with a fifth dose of DAPTACEL (batch number: C4709AA, expiration date 24 February 2017) by intramuscular route in the left deltoid and a fifth dose of IPOL (batch number: L1130-1, expiration date 11 April 2017) by intramuscular in the right deltoid on 19 May 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 21 May 2016, two days following the vaccination, the patient experienced local reaction going from left deltoid injection site down to the elbow which was red, tender, hot, and itchy and also had trouble in lifting his left arm. It was also a case of wrong route of administration, product use issue and needle issue as the reporter thought that it (vaccine) might not have been given intramuscularly and had given subcutaneously with a shorter needle. On an unspecified date, patient required ER or doctor visit. Lab data and corrective treatment were not reported. Outcome of the events was reported as not recovered. List of documents held by sender: none.
Pfizer dose #1 administered at 1030 AM, Pt was given 10 ml Zyrtec prior to her injection today due to her reports of allergies and sensitivities to some medications and history of allergic reaction to Humira and local reaction of swelling at inj site with Prevnar 13 and Tdap in past. Says she had a reaction to flu vaccine years ago and unsure of what caused the reaction.  Depart: 1045 pt began to complain of "not being able to take a deep breath" and lightheadedness and weakness in legs. Pt has history of asthma, said she did not feel like her breathing felt like asthma, lungs sounded clear to ausculation.  Vital Signs: BP 120/80 O2 sat 99 Pulse 99 Resp 16 Epi given 0.3 mL IM L Deltoid and pt was transported to ER via wheelchair by ER RN.
Within 10 minutes, the patient developed one hive with itching on left lower leg. Within 2 minutes, he developed pruritus on arms. No other associated symptoms.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fever-Mild
Patient broke out in shingles-like rash on the arm that she received the vaccine in. Patient also reported experiencing nerve pain in that arm.
w/in 24 hrs devel pain, 8cm erythema & swelling lt arm shoulder-elbow, also devel lt axillary adenitis; tx symptomatically;
At the end of the post-vaccination waiting period, the patient reports red spots in the right anterior forearm area (in the right deltoid). Pt itching on the red dots and on the head. Patient is medicated with BENADRYL P/O according to medical order of Medical Director. Patient reports symptom solution within 20 minutes of being medicated, and the red spots disappear.
Within in 48 hours sharp pain in left shoulder with limited range of motion. the pin has not subsided byt has seemed to shift location moving down my arm No swelling but sharp pain and  soreness  Dailey activities are difficult and extreme trouble sleeping
No additional AE information reported; ROTATEQ was administered after a supported temperature excursion; This spontaneous report was received from an other health care professional referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion with 49 Celsius degrees for 72 hours. There was no previous temperature excursion. On 24-FEB-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742462, expiration date 19-SEP-2022; strength and dose were not reported) orally for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA000194:
Right lower extremity deep venous thrombosis in popliteal and femoral veins, swollen discolored leg
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8731), on 04May2021 as dose 2, single (Lot number: EW0167) and on 11Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 80 years for Covid-19 immunisation. The patient's relevant medical history included: "Back problems has had for years" (ongoing), notes: Caller states she has issues with her back, has had them for years; "Fibromyalgia" (ongoing), notes: Fibromyalgia has had for years. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "tested positive"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "symptoms were worse"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: she tested and tested positive. Therapeutic measures were taken as a result of sars-cov-2 test positive.
Itchy all over; Developed a rash on his posterior neck area, top of both shoulders, all over his back, and torso; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy all over) and RASH (Developed a rash on his posterior neck area, top of both shoulders, all over his back, and torso) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced PRURITUS (Itchy all over) and RASH (Developed a rash on his posterior neck area, top of both shoulders, all over his back, and torso). At the time of the report, PRURITUS (Itchy all over) and RASH (Developed a rash on his posterior neck area, top of both shoulders, all over his back, and torso) outcome was unknown.            No concomitant medications are provided .  The patient had been doing fine for the past 2 months or so.  No treatment medications are provided .
Completely healthy menstrual cycle for 37 years. Received small pox vaccine and prolactin shot up rendering me infertile, with no menstrual cycle the same month.
Right arm redness and soreness. Pt given APAP and Ibuprofen to alternate. Advised pt to ice her arm today to bring down the swelling. Suggested CLARITIN or BENADRYL at bedtime as well.
My son was complaining of dizziness and also had a fever of 102.3 , x5 days after 2nd vaccine, the dizziness lasted about 7 days,
Serious headache, Body ache and Fever. Symptoms worsened through the night and through the next day. Motrin, Tylenol were not helpful. This shot should come with a warning.
AFTER 5 MINUTES PATIENT RECEIVED THE VACCINE ,PATIENT FAINTED AND SUSTAINED SOME INJURIES AROUND HIS RIGHT EYEBROW  WHILE HE IS IN THE WAITING AREA. PARAMESICS ARRIVED AT THE SCENE AND PATIENT REFUSED FURTHER TREATMENT. HE WAITED ABOUT 20 MINUTES AT THE WAITING AREA AND LEFT THE STORE.
My son has psoriasis - Finger tips peels were the first notice, very badly that following cold season, and spots on legs of psoriasis that have now turned up this year 2019. I started to have psoriasis in the same manner after my middle school shots as his mother. Itching causes more of a flare up and worsens in the winter.
Severe foot pain from ankle to sole of the foot. At first I couldn't stand up. Tired, I had to lie down. Continuous same on second day. Drowsy.
Pt had TDaP administered on 8/29/06, pt called my office the morning of 9/1/06 reporting concerns about a vaccine reaction. Administered in left deltoid area and pt only had mild soreness in the arm then the next day had. Soreness, redness and swelling at site of administration.
iIches the rash, it is so uncomfortable; Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (iIches the rash, it is so uncomfortable) and RASH (Rash on arm ) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Kidney function abnormal.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced RASH PRURITIC (iIches the rash, it is so uncomfortable) and RASH (Rash on arm ). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (iIches the rash, it is so uncomfortable) and RASH (Rash on arm ) outcome was unknown.            Patient taking lot of medications for blood pressure.   This case was linked to MOD-2021-397536 (Patient Link).
started with itching on back of neck.  moved to show hives and then throat itching.  Given benadryl 25 Im, pepcid 20 mg po.  Initially improved, but itching started coming back.  progressed to throat itching again. Given another 25 mg IM benadryl.  2-3 minutes after the benadryl, throat started feeling tight and she was coughing a little, so epi Im given and paramedics called.
VISUAL LOSS LEFT EYE ONSET 3-4 DAYS AFTER FLU VACCINE.
Information has been received from a physician concerning a 2-month-old patient who was vaccinated PO with first 2.0 mL dose of rotavirus vaccine.  The physician reported that the patient subsequently became irritable with symptoms of diarrhea.  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Received shingrix 12/4/2020. Developed exercise intolerance, palpitations, dyspnea afterwards. Exercised w/o problems until 12/4/20. Symptoms got progressively worse. EKG on 12/21 /20  showed SVT vs a fib at 172 bpm. Sent to the ER. Spent  2 nights in the hospital. Echo showed severe MR. New onset a fib. Echo in 09/2020 showed mild - mod MR. Symptom onset coincided with vaccine administrtaion
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/17/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 5/17/2022 CARDIOGENIC SHOCK
Client's mother reports that the client developed the symptoms of memory loss, severe headache, and seizures twelve hours following the vaccine administration. Client's mother reports that these symptoms are persisting now, one week after they began. The client has been evaluated at two emergency rooms and in the PCP's office with no identifiable cause of the symptoms.
after reconstitution was stored overnight/pt refused vx.; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) (batch number DH3SB, expiry date 20th May 2024) for prophylaxis.   On 12th January 2023, the patient did not receive Shingrix. On 12th January 2023, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt date: 13-JAN-2023 Reporter Comment: The pharmacist reports that a Shingrix vaccination reconstitution and stored overnight in a syringe under refrigeration. Vaccine was drawn up for patient and then patient refused vaccine. The reporter consented to follow up. Additional supportive information: After Shingrix vaccination reconstitution vaccine was stored overnight in a syringe under refrigeration and did not receive by the patient which led to intercepted product storage error.
Patient complained the injection was painful and after removing the syringe there appeared to some swelling. We applied cold pack and she went home - no dizziness, hives or itching.
pain between my finger joints in wrist and in pads of fingers, predominately in right hand after first shot left hamstring and glut muscles after second shot
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 25-SEP-2015, the patient was vaccinated with an improperly stored dose of PROUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
4MAY95 mom states pt rt leg swollen, painful to touch & has been crying since left WIC 1130AM; told to take pt to MD today;
Mother of client states client has numbness to left arm, headaches, and fast pulse. Advised mother to take client to doctor if had concerns.
Severe, uncontrollable shivering. Temp: 100.5. Duration: 50 minutes. Rx; TYLENOL.
Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and nausea.
On May 16th after the shot I got a slight headache then 3 days later was feeling very tired and went to bed,  woke up a few hours later with numb legs and feeling very faint with numb lips..became unresponsive and Fire Rescue responded and took me o the hospital where they said all test were ok.
Given Shots On Wednesday, July 16, 2008.  Early Friday, July 18, 2008, 3:00am woke up with a very rapid, racing heart. 9:00am woke up with difficulty breathing.  Saturday, July 19, 2008, went to work.  Almost passed out three times, guessing about a fever of 102F, profusely sweating.  Called CDC, told to call doctor immediately.  Called on call doctor - said to, "Ride it out."  Sunday, July 20, 2008 called into work.  Fever of 102F, painful aching in feet and legs.  Monday, July 21, 2008 called into work.  Fever of 102F, painful aching in feet and legs and joints - particularly left hip joint and right knee, skin very sensitive to touch and can only stand very light touch.  Massaged area, took salt bath, took aspirin.  Tuesday, July 22, 2008 went to work, took aspirin, profuse sweating, difficulty breathing, difficulty concentrating, extreme muscle fatigue, particularly in back.  Asked co-worker for massage, skin and muscles very tender to the touch.  Feels like I need to stretch but cannot seem to get any muscle relief.  Wednesday, July 23, 2008 - called into work because of 102F fever and no sleep.  Had chills all night, pain in ribs, dry cough, 103F fever at night.  Thursday, July 24, 2008 - Had chills all night, pain in ribs, dry cough, 103F fever at night, hallucinations.  Left message at doctor's office for them to call me back.  Friday, July 25, 2008 - Extreme muscle fatigue, bone pain, mostly in back and ribs, pain in eyes - particularly when moving, stiffness in neck. Left message at doctor's office for them to call me back.  Saturday, July 26, 2008 - called into work.  Called doctor that was on duty took three hours for them to return page.  Nurse relayed information to Dr., advised that I should visit ER.  Same symptoms as before with continued pain in eyes.  Black Diarrhea all days.
High fever (102-103F), weakness, confusion, dizziness, full body aches, painful sensitivity to light and touch, nausea, extreme fatigue, brain fog, short term memory loss, difficulty finding the right words for things, struggling with simple tasks/planning/decision-making.  The fever, nausea, and the intensity of the aches and light/touch sensitivities resolved after 72hrs, but the other symptoms: weakness, confusion, dizziness, extreme fatigue, brain fog, short term memory loss, difficulty finding the right words for things, struggling with simple tasks/planning/decision-making persisted for about 7-8months
Pharmacy prepares all Covid-19 vaccines in syringes.   Pharmacy performs an inventory count at the beginning and the end of clinic to reconcile the number of doses dispensed/administered and the # of unopened vials that remain.  At the end of clinic on 3/31/21 when pharmacy was reconciling the vials remaining it was noted that there was an extra vial of Pfizer Covid Vaccine that did not reconcile with the # of doses dispensed and administered.  After investigating it was discovered that a Pfizer vaccine vial was used/reconstituted twice.  Therefore it was determined that of 98 patients, 6 patients received normal saline instead of Pfizer Covid Vaccine. This included 90 second doses and 8 first doses. It is not possible to know which of the 98 individuals received the vaccine or normal saline.  After consultation with the Department of Health and the CDC's Vaccine task force, it was determined that the best course of action is to offer all 98 vaccinee's the option to repeat the vaccine dose.   We will be offering vaccinee's an additional dose of Pfizer or J&J/Janssen at an interval of 21 and 28 days, respectively.  This is being done by direct notification of the patients via phone call describing the error and the optional recommendation for repeating the dose. Providers of the patients have been notified. All vaccinees will be informed of the potential of  experiencing more pronounced side effects with an additional dose. For patients who decide to receive the extra dose, the previous dose will be removed from the Registry.   The root cause analysis of this event revealed that the incident was related to a pharmacist not discarding a used vaccine vial as soon as it was used.  Pharmacy implemented corrective action plan, which included reeducation to all preparing vaccine and new measure to assure pairing of one vaccine vial with one normal saline vial for each set of 6 doses prepared and discarding used vials as soon as the preparation and checking process is complete.
Vaccinated for Covid with Pfizer vaccines x 2 in August 2021.  Symptoms started 12/19 - fever, sore throat, cough, headache, myalgia, nasal congestion.
Patient had fever of 100.3 F and nausea on the day after the vaccine.  Patient able to return to work the following day without issue
4 hours after shot - heaviness below the waist and odd feeling in legs Day after - sharp back pain and trouble walking, soreness in legs 3 weeks post 1st dose - extreme twitching in legs and hands Month 1-3 - Very painful pins and needles, poor circulation, hurt to stand for more than a few minutes without it feeling like blood flow was pooling in feet, systemic flushing, inflammation in legs, torso, hands, arms, very blue and bulging veins, twitching continues now spasms and huge jerks in body Month 3 - hair started falling out at rapid rate, broken blood vessels start appearing on legs along with cherry angiomas, twitching continues, poor circulation and inflammation still present Month  6 - Hair stops falling out, poor circulation still present but has lessened substantially, twitching and spasms still very strong Month  9 - start getting extreme chest pain and rapid heart beat coming out of chest, twitching and spasms are still throughout body but mostly concentrated on left side of face now