chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no appetite; blurry vision; nasty weakness; purple area around the injection site; vomit intensely; intense headache/like their head was going to explode/headache was really strong; felt like they were getting covid-19; could barely sleep; Chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep), DECREASED APPETITE (no appetite) and VISION BLURRED (blurry vision) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 11-Jul-2021, the patient experienced SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep) and CHILLS (Chills). On 14-Jul-2021, the patient experienced DECREASED APPETITE (no appetite), VISION BLURRED (blurry vision), ASTHENIA (nasty weakness), VACCINATION SITE DISCOLOURATION (purple area around the injection site), VOMITING (vomit intensely) and HEADACHE (intense headache/like their head was going to explode/headache was really strong). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 600 mg. On 13-Jul-2021, SUSPECTED COVID-19 (felt like they were getting covid-19), INSOMNIA (could barely sleep) and CHILLS (Chills) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (no appetite), VISION BLURRED (blurry vision), ASTHENIA (nasty weakness), VACCINATION SITE DISCOLOURATION (purple area around the injection site), VOMITING (vomit intensely) and HEADACHE (intense headache/like their head was going to explode/headache was really strong) had not resolved.            Concomitants medication patient was on prenatal vitamins since last pregnancy. Patient states they have had very strong covid-19, that left the patient with asthma, that they did not have before. No lab data has been provided by the reporter.
Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Within 15 minutes of receiving the 2nd dose of Pfizer, the patient fainted. One of our pharmacy technicians described it as looking like a seizure episode. Pt was seen right away by the pharmacist and nurse practitioner. Patient came to and became alert and oriented. BP was measured to be 82/55. Pt was monitored and after resting, BP came back up to around 130/90. Pt was monitored until they felt normal and were comfortable to leave.
I had chest pain right between my sternum, burning sensation with tightness. It started about 5 PM and lasted about 48 hours until I went to the ED.
102.7 fever last night; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 27th April 2022, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingrix vaccine on Tuesday and had all side effects including 102.7 (unspecified unit) fever on last night before the reporting. The patient asked when side effects would stop. Additional Supportive Information: The follow-up would not possible as no contact details were available.
aches, pains; nausea; lymph node swelling; This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patients. This is 1st of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 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's medical history and concomitant medications were not reported. The reporter stated that after the second dose, the patient (reporter's mother) described aches, pains, nausea and lymph node swelling on an unspecified date. On 15Mar2021, the reporter stated that her mother mentioned this to him/her (the reporter) on behalf of herself and his/her father. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276527 Same reporter/product/event, different patient
Pt became cool, clammy and diaphoretic, BP 110/60, 120/70. O2 given accur 89, EM scaled, taken to ER for further eval. MD tx: arrhythemia, anxiety
Felt achy after 1st dose; 1st dose a year ago, hasnt got the 2nd; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The reporter was the patient and mentioned that she felt achy when she received her first Shingrix vaccine in an unknown arm about 1 year prior to the reporting date.  She was hesitant to get the second Shingrix vaccine because she did not want to confuse the achy feeling with Covid-19. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Ringing in left ear after 2nd dose on 4-14-2021  No issue after 1st dose given on 3-17-2021
within 24 hours developed rash/hives. 48 hours developed numbness of lip with swelling which has persisted although decreased over time and is still present at week 3
I was exposed to COVID-19 04/17/22 and became ill on 04/20/2022 with symptoms of chest congestion, chills, runny nose, slight to moderate fatigue, and the next day developed slight nausea, coughing up congestion of yellowish discharge. O2 and BP remained in normal range. Ran a low-grade temp of 99.5 on day 2 only. I still have congestion and am experiencing some COVID-19 symptoms.
Extreme pain in entire L UE, nausea, fatigue, chills, hot flashes, headache, dizziness, brief and mild SOB, itchy rash over entire torso worse on L side. Pain in UE gone in ~30 hours from injection, headache from 12 hours to 36 hours, rash 30 hours to 54 hours.
Pt developed fever of 100.5at 2:30am, temp of 102.5 at 8:30am, pt arrived to hospital via ambulance at 12:22pm after reported 3-4 minute febrile seizure. Hospital is the one who informed our office of adverse event.
This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011908, 1407USA011909, 1407USA11910, 1407USA011911). Additional information has been requested.
Soreness in her left arm; Some slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her left arm) and NAUSEA (Some slight nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness in her left arm). In 2021, the patient experienced NAUSEA (Some slight nausea). At the time of the report, PAIN IN EXTREMITY (Soreness in her left arm) and NAUSEA (Some slight nausea) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided.   This case was linked to MOD-2022-576700, MOD-2022-576759, MOD-2022-576600 (Patient Link).
Case received from a Healthcare Professional on 12 October 2010 under the reference number 10-0706. A 32-year-old female patient, with no relevant medical history and no illness at the time of vaccination, had received an intramuscular dose of ADACEL (batch number C3491AA) in the left deltoid on 08 October 2010. The patient had received an intramuscular dose of FLUVIRIN (other manufacturer, batch number not reported) in the left deltoid on 23 September 2010. She had received concomitantly prenatals vitamins. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. She did not experience adverse event following prior vaccination. On 09 October 2010, the left deltoid was sore. Two days post-vaccination, the patient noticed two open blister like areas on the left deltoid posterior to the injection site. "By sunday", blisters were oozing and bloody. The patient was seen by a physician who recommended hydrocortisone cream. The patient had not recovered at the time of reporting, symptoms improving slowly. Documents held by sender: none.
1 - 1 1/2 hr after vaccines - developed generalized rash. Treated with antihistamines in ER.
Initial information received from a non-healthcare professional who is the patient on 12 September 2013 via another manufacturer. This reporter also reported another adverse event which is captured in case number 2013-09547. The reporter is the patient's mother. The reporter received an unspecified TDAP vaccine on an unreported date. The batch, dose and route were not reported. The patient experienced an unspecified severe allergic reaction after receiving TDAP vaccine. The patient received the vaccine into her shoulder, side not specified, which according to the reporter may be "other than indicated". Following administration at an unreported time, the patient "blew out her shoulder" and was hospitalized at an unspecified hospital for an unspecified amount of time. The patient and her son have a history of severe allergy to nickel. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/29/2022,  1/4/2023,  2/23/2023,  1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Initial case was received from a non-health care professional on 27 September 2013. This 4-year-old female patient, whose medical history and concomitant medications were not reported, had received INFLUENZA QUADRIVAL A-B VACCINE 0.5 ml shot (route was not reported) during a family clinic in her upper arm on 25 September 2013. Her injection site was red, swollen, warm to touch, and tender. The area is approx 2.5" x 2.5". The patient said it hurt immediately following the shot and continued to say that hurts, until morning. The next morning, approx. 36 hours after injection, her arm was still red, swollen & warm. Not laboratory tests were reported. The corrective treatment was not reported. List of documents held by sender: none.
Patient was given vaccine twice in the same arm at the same appointment.  The patient was counseled on possible increased side effects.  THere is no follow up.
Delayed menses by 5 days. I am always +/-1 day and have been since the start of my menses 18 years ago. I was vaccinated two days after ovulating at my menstrual cycle started 5 days later than expected. All PMS symptoms were delayed.
This spontaneous report as received from a registered nurse, refers to a 12 month old patient of unknown gender. The nurse reported that a patient received both PROQUAD (Merck) (lot number was not reported) 0.5 ml, subcutaneous, and VARIVAX (Merck) (lot number was not reported) 0.5 nl, subcutaneous, on 09-JUL-2013. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Redness and swelling in the arm. Patient described as a rash. Informed to take TYLENOL and apply ice.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment drug was not reported.  This case was for the 117th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
received a dose / already expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old male patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 31st January 2022, unknown after receiving Engerix B pediatric 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 a dose of Engerix B pediatric that was already expired on 24th January 2022, which led to expired vaccine used. The vaccine administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Large DVT left leg stretching from mid-thigh to mid-calf Many multiple pulmonary emboli Small non-symptomatic saddle block  Hospitalized, treated with lovence and subsequently discharged on Xarelto.  Expect to be taking Xarelto for at least 3-4 months.  Supplemental O2 4lpm 24/7
pt recvd MMR 6NOV92; On 14NOV92 pt broke out in facial rash, moving to trunk & extremities w/fever (amt not documented), cough, runny nose, conjunctivitis; macules began about 3 mm in size, became coalescent;
Slight nausea/headache starting 3 hours after shot.  After 10 hours: moderate fatigue. After 12 hours: severe flu-like body aches (8/10 scale) then severe chills (9/10 scale) lasting about 4 hours.  Moderate body aces (3/10 scale) and headache 20 hours after shots. Had Moderna vaccinations in April/ May 2021
Under observation for 30 minutes after vaccine due to history of anaphylaxis after a previous vaccine. No problems until about an hour after injection experienced swelling and itching in throat, tongue and jaw. Seen at ED and given steroids. Following week still having intermittent tongue and throat swelling/itching, as well a diarrhea and chest tightness. Referred to PCP for further evaluation and guidance regarding receiving second dose.
Severe pain at site, general malaise, which developed later in the night to chills, nausea, epigastric pain. Headaches, arthalgias, myalgis especially hip, shoulder and knee pain with pain and tenderness of gluteal, thigh and calf muscle, profound fatigue, difficulty going up stairs due to pain and walking, even driving painful on legs, fever of 100.2 - 100.6, chills, very scary. At present pain at site decreased but arthralgias/myalgis and tiredness still present and the headache and GI upset.
Death Narrative: Patient passed away on 3-2-21, patient received the vaccine on 2-24-21. Patient was obese and had several co-morbid conditions.
Patient fainted approximately 15 minutes postvaccination.  Felt better after drinking some water and was released to home.
Shortly after he received the vaccine (an hour or two afterwards), his left deltoid became very swollen and red.  It was warm to the touch and very painful.  The swelling persisted that night.  It did not start going down until the following day.  As of 2/18/19, his arm is no longer swollen but it is still very painful and he describes it as feeling like a deep bruise.
ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Information has been received from a health professional concerning a 9 year old male with hypersensitivity to amoxicillin and no pertinent medical history who on 25-MAY-1999 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). There was no concomitant medication. There was no illness at the time of vaccination. On 25-OCT-2007, the patient developed a rash on his face and torso for "one day". The patient was afebrile. On an undisclosed date the patient also developed itchy vesicles and was reportedly asymptomatic. The patient recovered from the rash on his face and torso in one day, and the itchy vesicles on an undisclosed date. Additional information was received from a nurse who reports that the rash was originally thought to be chickenpox on 25 OCT 2007, but when the child was seen on 30 OCT 2007 for an unrelated condition, the rash on the face and torso was diagnosed as poison ivy. No further information is expected.
My legs felt like I had shingles (I had shingles before).  I was in much pain.  Next day I was unable to do anything, I stayed in bed all day.  The next 2 days after that I was weak.  The pain in my legs slowly ease up.
Complained of tightness in throat and chest, heart racing, anxiety after vaccine.  Went to  Urgent care and was seen by  PA-C.  Patient was given a Benadryl shot  with a weird panic attack noted before she received it.  Legs shaking and couldn't stand.    Felt better after she received the shot/
Mom reported on 3/14/01 to nurse, while in office with second child, that this pt presented with a hard lump at injection site of Prevnar. Said it was swollen and red, approx. size of a ping-pong ball. Thought it was normal reaction so did not call us. On 3/14/01, he still had hard lump at site. Child was not with mother when reported.
Arthralgias in multiple finger joints. Also, pain in knees. Pain began as soreness/sensitivity and slight redness of the 4th proximal interphalangeal joint of the left hand. Onset was about 1 month after the injection. Other finger joints have become sore over the next several weeks. Knees and elbows are unusually sensitive to pressure or positional changes. The symptoms have not subsided. Pain in the left 4th interphalangeal joint has not improved. It does not keep me awake at night but is painful, when I type or move that finger joint. It feels like pins and needles are in the joint. I have a milder but similar sensitivity in other joints. I'd never had arthritis pain pain in my hands. I do have a history of patella-formoral syndrome, which resolved a couple of decades ago with exercises that I still perform.
Miserable with fever on Sunday. Skin lesions started on Tuesday, which are mostly red a few are papular.
Symptoms began Monday 21st- headache, body aches, injection site sore; couldn't taste or smell -went  Emergency Room - Medical Center; was given Tylenol and ibuprofen and was given Covid Test - test result positive.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm), erythema (red arm), chills, headache (woke up in night with massive headache) and pyrexia (felt feverish but did not have fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025C21A and 040B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history provided. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 8, 2021, patient experienced vaccination site pain (tenderness at vaccination site). On May 6, 2021, patient experienced peripheral swelling (swollen arm), erythema (red arm), chills, headache (woke up in night with massive headache), pyrexia (felt feverish but did not have fever) and myalgia (arm very sore for 2 and half days). On May 7, 2021, patient experienced fatigue (on next day extremely exhausted). At the time of the report, peripheral swelling (swollen arm), erythema (red arm), headache (woke up in night with massive headache) and myalgia (arm very sore for 2 and half days): resolving; chills, fatigue (on next day extremely exhausted) and vaccination site pain (tenderness at vaccination site): not resolved; and pyrexia (felt feverish but did not have fever) resolved. Patient took Advil to treat the symptoms. No concomitant medication provided.