chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following the administration of the vaccine pt passed out knocking his head on the ground. Upon opening his eyes pt stated that he felt dizzy and ringing in his ears. Jerk like movement noted in lower extremities. Pt moved to chair and vitals assessed. BP-96/62 / HR- 49/O2 sat 100%. Denied SOB or difficulty breathing. Mother notified and pt rested by 30 minutes. VS rechecked. BP-110/68/HR-65/R-20/O2 sat 100%.
patient woke up on 04/22/2021 with shortness of breath and weakness.  On exam, she was hypotensive, tachycardic and edematous
pt given Td vax on 2FEB93 & returned on 4FEB93, reddened area 5x5cm, warm to touch, t100.4; pt examined on 4FEB93 @ 330PM by MD;
DVT/PE diagnosed 10/19/2021 IV Heparin, oral Eliquis 5mg twice daily for 6 months
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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 was not reported. Concomitant medication(s) included: LEVOTHYROXINE, start date: 11Jul2022, stop date: 17Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) positive, notes: Positive Covid-19 test on 17Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment with Paxlovid in Jul2022. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
AFter vaccine was given IM, patient said felt nausea.  I asked her to sit down and instructed to go to bathroom if needed and to wait in store for 15 minutes.  3 minutes later, patients eyes rolled in back of head and she had seizure like symptoms.  Patient refused epi pen and was breathing.  Patient was laid on floor until paramedics arrived.
Felt Horrible; This case was reported by a nurse via call center representative and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The healthcare professional stated that she felt horrible for a week after the immunization. The healthcare professional submitted as much information as she provided in the email. The reporter did not consent to follow up.
Very sore at injection site Fever 100.6 Chills Fatigue  Tight chest Cough when taking a deep breath
Client was given 3 vaccines (Hep A, Varicella and Gardasil) and within 10 minutes of administration, the client began complaining of chest pain. Assisted to a supine position. BP was 78/20 and pulse was erratic and nurse not able to count.  EMS was called.  Client remained conscious. BP was 128/90, HR 100 when she left with EMS.
Hives and itching, 10:00 p.m., lasting about 30 minutes. Applied Aloe-Vera gel to upper arms, abdomen and thighs.
Pt c/o feeling flushed 15 mins after receiving 1st dose of the vaccine. She denied allergies or any past med hx. She was assessed and monitored by NP, EMT and paramedic. BP - 135/70, HR - 60, resp - 14, O2 sat 98% on RA, skin was warm, dry.
Significant body aches and pain all over body, fatigue, headache, injection site pain the night after getting the vaccine
So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a 82 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced atrial fibrillation, so tired and no energy, very weak.  Patient's medical history included atrial fibrillation. Relevant concomitant medications included prednisone and benadryl.   On 28 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On the same day, patient experienced atrial fibrillation.  On 29 JAN 2021, she was so tired and had no energy and was very weak which lasted for 6 days. She thought that this was due to prednisone and Benadryl prophylactically. On the same day, her sinus rhythm was found to be back to normal. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events atrial fibrillation was considered resolved on 29 JAN 2021 and the events so tired and no energy, very weak were considered resolved on 04 FEB 2021.; Reporter's Comments: This case concerns an 82 year old female patient, with medical history of paroxysmal atrial fibrillation (2016), who experienced a serious unexpected event of atrial fibrillation, among other non-serious events, after receiving first dose mRNA- 1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Pain and swelling around left jaw and parotid gland. Resolved quickly with augmentin and prednisone.
This spontaneous report was received from a medical assistant via physician regarding a multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB injection lot # M001813 with expiration date 14-OCT-2018 and lot # M046134 with expiration date 27-SEP-2019 (dose and route were not reported), for prophylaxis. The storage temperature was 32 F to 35 F and time frame was 1 hour (incorrect product storage). The patients has no previous temperature excursion. The patients used data logger. No adverse effects were reported. Additional information has been requested.
After thawing the vial she forgot to let it sit at room temp for 15 min; A spontaneous report was received from a pharmacist concerning an unidentifiable patient who was administered  mRNA-1273  for prophylaxis of COVID-19 infection. The pharmacist.forgot to let vaccine sit at room temp for 15 min before administration (PT: Wrong technique in product usage process).    The patient's medical history was not provided.  No concomitant product use was provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. After administering the vaccine, the pharmacist stated that they forgot to let the vaccine sit at room temperature for 15 min before administration.   Action taken with mRNA-1273 in response to the events was not provided.  The event forgot to let vaccine sit at room temp for 15 min before administration was considered resolved.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, lot # unknown.  with no associated AEs.
Patient reported SEVERE back pain about probably about 10 minutes after receiving vaccine. No lightheadedness, no trouble breathing, no nausea. Just VERY SEVERE back pain to point where patient cannot move. Called ambulance and patient was taken to emergency room.
Lung cancer discovered 5 months after the injection. Treatment included radiation and medications up till present. Symptoms included general weakness, shortness of breath, significant weight loss, plural effusion and drainage for 3 times. Condition is not yet under control (up till this time).
side effect after first COVID vaccine; A spontaneous report was received from a Consumer concerning a 2021- Years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, side effect after first covid vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the events, side effect after first covid vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events, side effect after first covid vaccine was not reported.   On an unknown date the outcome of events include, side effect after first covid vaccine was not reported.
ON DAY 11 AFTER VACCINATION DEVELOPED TENDER LUMP IN IPSILATERAL AXILLA
HAS RASH TO RT ARMPIT, NECK, CHEST AND LT WRIST. DENIES ANY DIFFICULTY BREATHING OR SWALLOWING.  ADVISED TO USE COOL PACK AND BENADRYL FOR COMFORT AND CALL PCP TO SEE IF CORTISONE SHOT OR OTHER TX NEEDED. GO TO ER IF SX WORSEN/JAW
Suspected vaccination failure; had permanent neurological damage to her legs and had to learn to walk again; GOT shingles; had to learn to walk again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), nerve damage (serious criteria disability), shingles and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, nerve damage, shingles and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, nerve damage, shingles and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles.  The reporter stated that, the patient had permanent neurological damage to her legs and had to learn to walk again.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with case US2021AMR156165, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156165:same reporter
Short term memory loss. Began 10-15 minutes after injection. Duration of symptoms: 2 to 2 1/2 hours.
After vaccine given, pt complained of tingling along anterior medial aspect L upper arm.  Hurt to move arm.  Also complained of "tingling" going down L anterior lower arm + fingers.  Fingers cool.  Gave pt acetaminophen 325mg 2tabs.  Was to return for re check in 1 hour but pt left; Seen 5/18- States symptoms resolved after approximately 24 hrs. By the next day better 5/15
received expired Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of Engerix B adult, which led to expired vaccine used. This case was linked with case US2021243036, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021243036:Same reporter
I am submitting this report per patient's primary care physician's request. Patient was hospitalized and was given Pneumovax prior to discharge on 3/16/09.  She had local reaction at injection site (L Deltoid) and was seen at the ER on 3/20 and 3/22 - prescribed Cephalexin and Septra for cellulitis. Seen by her primary care physician 3/23/09 for diffuse arthritis type symptoms; especially swelling and redness in both hands. Labs show positive ANA (profile and titer pending). MD now has her on course of Prednisone.  Primary care physician feels this is an adverse reaction to Pneumovax.  Patient has received this before and did not have any side effects.  She states she did not remember that she had received the vaccine previously.  Do not know manufacturer or lot # as this was not administered here at the clinic.
Blotchy, red-macular rash to left thigh. Warm to touch, swollen.
Upper left arm warm , stiff and really sore near injection site that continues for 20 days following Pfizer shot
mild problems with cough he had voice problems. NO IMPROVEMENT. In April he couldn't breathe also slurred speech. Ultrasound came back negative. Hard to swallow , cant lay down and breathe.
pt recvd flu vax SC instead of IM & pt devel redness & induration @ the inject site;
Pt was given flu shot on 10-15-14. He notified us the week of Oct. 27th stating he "had soreness left arm since flu shot". He was seen in our clinic 10/28/14.
(L) arm Pt had redness, soreness, swelling approx 3-4hrs later. Also jaw/cheek pain, dull headache, felt fatigue and dizzy in evening. Told pt to see provider-given Cephalexin 500 3x/day x 7d. SMZ-TMP DS 800/60 2x/day-7d.
Abnormal Pap result during pregnancy after Gardasil (hpv) vaccine. After having baby. Had a colposcopy, result was moderate to severe dysplasia. Leading my obgyn to do a LEEP procedure.
Two days after vaccines given pt had itchy eyes. Next AM upper and lower eyelids swollen and hives on face. This continued for 3 days. Pt seen in office 7/25/07 with angioedema of face. No trouble breathing. No relief with Loratadine or Benadryl. Trial Atarax.
Pt. mom reports had vomiting throughout night after vaccine. Vomiting ceased by AM but did stay home from school due to ill all night and headache.
A spontaneous report has been received from health professional concerning 7 years old, male patient. Patient relevant history, concurrent diseased and concomitant drugs were not provided. Patient received nasal FLUMIST Quadrivalent on 15-NOV-2014. The report stated that patient experienced flu like symptoms on 16-NOV-2014. Nurse did not know what exact symptoms the patient had. The outcome of the event was unknown. The reporter assessed the event of flu like symptoms as non serious.
Not recently, but want to report now. 3 Influenza vac, with identical reactions each time of visual change (marked) & headache. Recovered all 3 times within 6-8 hours.
Woke up delirious; Very unsteady, and she had to hold onto the wall to keep upright; She stated that she did some weird things; Had no appetite; Weak; 101.6 degrees fever; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm.  Treatment details included Patient took 3 Tylenols.  Action taken with mRNA-1273 in response to the events was not provided.   On 19 Feb 2021 the outcome of event events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described the pt as being very dramatic. It was further reported that the pt reported seeing genital warts to the nurse practitioner, however, the nurse did not feel these were related to the vaccine. Additional information has been requested. 7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma.  1/4/10 Lack of concentration, hearing loss, blurred vision-ringing in ears. All of these we are aware of.
Received second shot on 4/2/2021. Symptoms include extreme exhaustion, digestive issues, headache, joint pain, body aches, chills. Symptoms were debilitating for the first 2 days, but continue to limit my ability to work as of today 4/7
This spontaneous report as received from a other health professional refers to a 17 years old female patient with acne, dysmenorrhea and elevated TSH. The patient was vaccinated with lot # (670048/0963AA) dose 3 GARDASIL, IM, left deltoid on 29-DEC-2011 at 16:10. No other co-suspects were reported. Concomitant medications included: FLUMIST. It was reported that the patient received immunization that was stored at a temp out of range <32 degrees F. No adverse reactions occurred. This is one of several reports from the same source. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; METOPROLOL; LOSARTAN; VITAMIN D [COLECALCIFEROL]; BABY ASPIRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive, notes: Rebound case after testing negative several days in a row and feeling almost completely better - then symptoms returned and tested positive 3 days after last testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had small left supra clavicular adenopathy without erythema following the administration of rabies vaccine.
Fever 2-3 hrs p/inject; persisted into next day-then chill; generalized seizure occurred about 27 hr p/shot;
High Fever, 103.8 -16 hours, chills, headache, dizziness, high heart rate (above 120)
Pfizer-BioNTech COVID-19 Vaccine EUA.  Headache, chills, fever and nausea.