chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and High cholesterol.    On 10-Apr-2022 at 8:45 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Apr-2022 at 8:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    No concomitant medication was reported. It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown. It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events. No treatment information was provided.
Client reported chest pressure from her neck to her chest to the EMT's at 4:47 PM. The client was alert and oriented to person, place, time, and event. The client stated her current symptoms were less intense than her initial reaction. Vitals obtained at 4:49 PM were as follows: BP 126/78, HR 64, and O2 98%. The client denied any other s/s of anaphylaxis. At 4:52 PM the client stated the chest pressure was still present but mild. The client reported less chest pressure at 4:54PM. At 4:58 PM the client reported mild neck pain and chest pressure. At 4:59PM activated EMS. The client denied feeling cold or clammy. Vitals obtained at 5:03PM were as follows: BP 130/70, HR 64, and O2 96%. Felt similar chest pressure after she received the four doses of vaccines at her medical provider in the beginning of July but did not report the chest pressure to her mother.  Fire Dept assumed care at 5:09PM. Client and mother refused medical transport at 5:16PM. At 5:20PM the client denied any chest tightness or pain in her neck. The client ambulated unassisted with a steady gait out of the observation area at 5:23PM.
Patient got light headed and fainted.  Was eased to the ground by RN. Elevated legs.  She regained consciousness in 1 mins and remained laying down with legs elevated for 10mins.  BP 138/68 at 14:20.  Given water and candy.  BP 118/68 at 14:26.  Observed for 15 more mins and feeling well to leave with husband who was had no adverse reactions.
Subjective throat swelling, total body pruritus and tingling starting 7 hours s/p. Resolved with benadryl. Pt presented to the UC for eval the following afternoon. No anaphylaxis at that time.
Vaccines administered at 9:00AM. Pt awoke from nap at 11:30 a.m. with runny nose, cough, poor appetite and fussy. Mother gave TYLENOL every 4-6 hrs during the day as well as Hyland Cough Syrup and Hyland Teething Tablets. Baby was choking on mucous at 8:30pm and quit breathing with color change. Went to ER at 9:00pm. Fever 99.8 -> 100.5.
Information has been received from a physician concerning a 67 year old male patient who on 18-FEB-2011 was inadvertently vaccinated SQ with a 0.5ml dose of VARIVAX (Merck) (lot number not provided), when he was intended to receive ZOSTAVAX (Merck). No adverse symptoms were reported. Additional information has been requested.
Pfizer vaccine was administered - reported by patient. I21.4 ACUTE NON ST ELEVATION MI 5/3/2022 ACUTE NON ST ELEVATION MI I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/2/2022 ACUTE NON ST ELEVATION MI R09.02 HYPOXEMIA 5/3/2022 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 5/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 5/2/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXEMIA 5/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
Pt in clinic for vaccine admin. Received Hep B & MMR. Approx. 1 min after MMR, pt. felt lightheaded, dizzy, blacked out, then vomited w/diaphoriesis, weakness & shaking. Code called. VSS, taken to ED for further evaluation.
Extreme itchy hands and feet. Living on BENADRYL. Sorry neck. Non stop headache.
9/14/21-started vomiting/unable to hold anything down 9/16/21-brought to ER by EMS. Found in yard by neighbors naked. Has contusions to head .Not able to form a  conversation. He was tacycardic and hypertensive. Altered mental status. HR-121, BP 191/127. 9/18/21 at 1406 pt. was extubated. 9/19/21: Pt. Still unable to recall events of what  happened and why we are found in his yard.
Patient described her adverse event as causing her shoulder to have a limited range of motion.  She explained how her shoulder has continued to be sore and that lifting and moving her arm (especially when it involves the shoulder) is difficult.  She did say that just here lately it has slowly started to improve.
In the evening of the day he received the immunizations, child had fever which led to a febrile seizure and ER visit.
First shot One manufacturer - second shot different manufacturer; no issues reported by patient; no adverse issues at time of shot
Illness the following 2 days. Fever, chills, fatigue, headache, clouded thoughts, brain fog.
foot and lower leg on leg with torn miniscus in knee, swelled up next day after 2nd dose of moderna. today ,almost month later they are still swelled up
Headache States experienced headache that has not gone away after several days Narrative:  Employee presented to Employee Health Office on 1/14/21. He was advised to contact his PCP the same day for further direction on management of this issue.
Information has been received from a nurse practitioner concerning a 25 year old female with irritable bowel syndrome as concurrent condition and no known drug allergies who on 30-SEP-2008 was vaccinated intramuscularly in her left arm with 0.5 mL of the first dose of GARDASIL (Lot # 660387-1967U).  Concomitant therapy included hormonal contraceptives (unspecified) and CLARITIN.  On an unspecified date the patient developed a lump at the site of injection.  The patient sought medical attention via telephone.  At the time of the report the patient had not recovered.  Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received improperly stored dose of ROTATEQ (lot # L029615, expiration date: 15-MAY-2017) orally (dose was not reported). The administered dose of vaccine was exposed to a temperature of 33.3 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. The reporter provided, that data logger was used. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
approx 1hr p/vax presented @ hosp ER w/cont crying, shaking & turning blue;t99.3, pulse 100, resp 28;given epi & DPH & Solumedrol;pt improved;
This is a spontaneous report from a contactable consumer, from a contactable physician and from a contactable nurse. A 69-year-old female patient received first dose of PREVNAR 13 (lot/batch number M51193, expiry date 01May2017) intramuscularly on the right deltoid at 0.5 ml, single on 17Feb2016 at 10:36. Medical history included ongoing  hypothyroidism, hyperlipidaemia, ongoing allergies and she was sensitive to vaccines (she got sick, details unknown). Concomitant medications included SYNTHROID at 50mcg daily ongoing, PROZAC at 10 mg, daily ongoing, FLONASE nasal, 1 inhalation both noses daily ongoing, PROAIR at 10 mg, 1x/day, PROZEN 10mg daily and VIVELLE-DOT 0.1 mg transdermal patch 2x week. The patient mentioned that after being vaccinated on 17Feb2016, she was ok for 4-5 days, then could not work for 2 and a half weeks. All symptoms slowly improved starting from administration of antibiotic, given 1 and a half weeks after shot. It took around 5 weeks to feel okay. Clinical course was as followed: On 17Feb2016 the patient experienced upper respiratory infection (URI), and was treated with antibiotic from 10Mar2016; on an unspecified date in Feb2016, the patient experienced sick/got really sick, the arm site was painful for about three days and she could not lay on it, immediately had pain at the injection site. Four-five days after vaccination, on an unspecified date in Feb2016, the patient experienced severe chest pain, severe cough, she was very weak, had joint pain, muscle pain, headache, nausea, fever, chills, sweating/clammy. On an unknown date she experienced extreme dizziness. The events did not require emergency room or physician visit. The patient underwent unspecified laboratory test and Flu test on unknown date and resulted negative. The doctor prescribed clarithromycin for sickness and antibiotic for nausea; she took TYLENOL for pain at the injection site. No treatment was given for arm site was painful, chest pain, cough, she was very weak, had joint pain, muscle pain and headache. She did not recover from the events joint pain, while she recovered from the other events in 2016. Dizziness lasted 2 and a half weeks and clammy until antibiotic was started. The nurse considered there was not a reasonable possibility that URI is related to PREVNAR 13. Follow-up attempts completed. No further information expected. Follow-up (21Mar2016): New information reported from a contactable physician includes: details of suspect vaccine, medical history, concomitant medications, laboratory test (unspecified), confirmation that the patient provided information to the physician regarding the reported adverse events with the use of the vaccine. Follow-up (20Jun2016): New information reported from a contactable consumer included: new event Dizziness; con meds data; events outcome; lab test; course of the events. Follow-up (11Jul2016): New information received from a contactable nurse includes: new event (URI added), causality, medical history, concomitants and event details updated. Follow-up (22SEP2016): Follow-up attempts are completed. No further information is expected.
Information has been received via another manufacturer and from a 60 year old female with multiple sclerosis (diagnosed in September 1998). This patient initiated secondary suspect interferon beta-1a (REBIF) therapy for multiple sclerosis on 01-JUL-2002 and administered 44 mcg three times a week by subcutaneous injection. On 03-NOV-2006, the patient was vaccinated into the right arm with Pneumovax 23 and influenza virus vaccine (unspecified). Concomitant therapy included tolterodine tartrate (DETROL LA). On 04-NOV-2006, the patient had an infection at the injection site of the Pneumovax 23 vaccination on her right arm. The patient had fallen because she was so weak and was hospitalized on 04-NOV-2006. The patient was treated with SOLU-MEDROL and unspecified antibiotics. The patient was discharged on 05-NOV_2006. As of 19-JAN-2006, the patient's injection site infection from a Pneumovax 23 shot was resolved and it was unknown if the patient recovered from the fall and weakness. Additional information is not expected.
sick; couldn't move for 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased and sickness. On an unknown date, the outcome of the mobility decreased was recovered/resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the mobility decreased and sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot of Shingles vaccine and got so sick and could not move for 4 days. The follow-up could not be possible as no contact details were available.
Left arm numbness and tingling from fingertips to upper rib cage after 12 hours for about 6 hours, then visible swelling in the left axillary area with tenderness to touch and minor discomfort with movement for 48-60 hours after vaccination.
pt recvd vax on 8DEC92 & on the evening of the vax pt devel redness @ inject site; 9DEC92 devel swelling of arm & palpable axillary lymph nodes; & exp soreness of the arm & generalized aching; 12DEC92 devel non-pruritic rash on legs;
Admission Date: 7/7/2022 Discharge Date: Jul 13, 2022  PRESENTING PROBLEM: Hyponatremia [E87.1] COVID-19 [U07.1]   HOSPITAL COURSE: Pt. is a 78 year old male with PMH of hyponatremia secondary to SIADH, HTN, AAA, HLD, CHF, A-fib. Pt. presented to the ED with generalized weakness. He was found to have a sodium level of 119 and admitted to the hospital. COVID was found to be positive, but patient sating well on room air. Due to the patients complicated history of hyponatremia nephrology was consulted.  Picture consistent with SIADH possibly secondary to COVID 19. Patient was placed on fluid restriction and sodium trended up slowly.  Ultimately Lasix 20 mg daily was added with improvement in his sodium up to 129.  Patient was otherwise asymptomatic with his COVID-19 and did not require any further medical treatment for this.  He remained on room air throughout his hospital stay.  Patient's amlodipine was held based on blood pressure trend with starting Lasix.  Recommend for patient to have repeat BMP in 3-5 days to monitor sodium level.  PT/OT recommended discharging home with home health care and home PT and OT which was set up by care management.  Discharge instructions reviewed with patient and wife at bedside, all questions answered, voiced understanding.  Recommend patient follow-up with PCP in 1 week.  Patient discharged home in stable condition.
Developed COVID symptoms for a "few" days. Called his physician who referred him to the  local hospital for suspected COVID. Tested positive for COVID at the hospital and blood clots in the  lungs were discovered by CT scan. Patient was admitted to ICU for treatment. Details reported  to VAERS by hospital and the Health District
Patient was already in hospital for severe COPD.  While there, he was given J&J Covid-19 vaccination.  Approximately 11 days after vaccination, patient developed vomiting that could not be controlled.  He later developed abdominal pain that worsened and also could not be controlled.  Intravenous pain killers eventually hastened his passing.
A nurse reports post vaccine, within 12 hrs pt developed fever of 104F measured rectally.
h/a, temp 99.5, stuffy nose, severe muscle aches & pains all over body, broke out in hives, face/lt thigh ;
Ten minutes after administration patient became sweaty, nausea, light headed. I had patient elevate his legs. i got cold compresses for his face and some water to drink. He then said he felt like he had to vomit, which he did into our wastebasket. He sat back and his eyes rolled back. I felt he was going to pass out. I had a pharmacy technician call 911 and stayed with the patient until EMS arrived. Patient was checked out and released to go home. I spoke to patient today and he said he was fine after a few hours.
A fever started 12 hours post Hep A, penumococcal and Flu vaccine accompanied by shaking and chills.  Presented to the ED on the morning of 10/14 and was admitted.  His chest x-ray revealed a new LLL consolidation.  He also noticed tenderness at right arm injection site.  He was started on Piperacillin/Tazobactam and Levaquin on 10/14.  Vancomycin was started on 10/16.  Piperacillin/Tazobatam and Levaquin were D/C on 10/17.  His right arm had increased redness and swelling though discharge on 10/20 when he was sent home on Levaquin 750 mg daily. 11/28/06 Received medical records from hospital which reveal patient had advanced liver disease caused by biopsy confirmed hep C virus infection & pulmonary fibrosis caused by biopsy confirmed interstitial pneumonitis.  He was seen in hospital to w/u for liver/lung transplant & vax with Hep A, pneumo & flu was given 10/12/06 in preparation for transplantation.  Patient developed fever & chills, SOB, cough, malaise & diaphoresis following day with local reaction at injection site.  Dx in ER was LLL pneumonia & cellulitis & patient admitted for IV antibiotics. DX: LLL pneumonia; right arm cellulitis; pulmonary fibrosis secondary to interstitial pneumonitis; advanced liver disease caused by hep C.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 26-FEB-2015 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J014568, expiration date 18-FEB-2015, (dose, frequency and route were not reported). No adverse effects were reported. Additional information has been requested.
In about 1.5 h after the shot crawling sensation appeared on the site of vaccine. That sensation moved up left side of neck, felt in head, lowered on the right side of neck and felt throughout the whole body.  911 was called, didn't find any stroke signs and left. Next day - vomiting (once) and diarrhea. The day after extreme headache that wouldn?t respond to double dose of Zomig 5mg, took 2 Tylenols and it subsided. Headache lasted for 5 hours. The day after ringing started in left ear with echoing of the sounds. Took 2 Tylenols and it subsided. Numbness in the left side of the head and left ear are persistent. Also experiencing extremely heavy period.
After both doses of the moderna vaccine, my menstrual cycle has become erratic. My menstrual cycle is becoming extremely short. My menstrual cycle previously has always been very regular. Typically my menstrual cycle would be 28 days apart with heavy bleeding that tapers at the end of my cycle. I am now experiencing menstrual cycles that last only 20 days and little to no bleeding. I am only ?spotting? while on my period now.  Something is wrong and other women I know  who have taken the moderna vaccine are having this issue just exactly the same as myself.  It?s like my body cannot have a proper menstrual cycle. To add, I have confirmed that I absolutely am NOT pregnant.
Patient observed for 30 minutes post vaccine, when patient verbalized dizziness. She also stated stated she had the same feeling with the first dose. She had vitals, enhanced observation and hydration with no improvement so she was escorted to employee heath services with a Nurse.
Syringe was injected into patient, but the syringe contained no vaccination. Site lead was contacted. On call provider was notified. Patient was authorized to receive repeat dose. Patient was educated on possible side effects.
flu like symptoms with increased bruising all over body; flu like symptoms with increased bruising all over body; This is a spontaneous report from a contactable nurse, patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24May2021 at 14:30(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypothyroidism, and hypertension. Patient had several unspecified allergies. The patient received unspecified other medications within two weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26May2021 at 02:00, the patient experienced flu like symptoms with increased bruising all over body. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event flu like symptoms with increased bruising all over body was recovered with sequelae on an unknown date in 2021, at the time of this report.   Information about lot/batch number has been requested.
In April I woke up and could not move my whole right side was heavy and I could not move it. I tried to get out of bed and fell on the floor. Once I got up and tried to walk it would throw me off balance. Sometimes I would fall sometimes I would just lean over and wait until I would regain my strength. I went to see my doctor four days later. He put me on PLAVIX, my right side extremities are still a little bigger than the left side. I am awaiting on an appointment to see a Neurologist.
Broke out in hives. Took BENADRYL and the hives slowly went away. The patient just let us know about this.
Patient reported via phone on 7/29/16 that he is experiencing severe pain to his right arm which has caused him to reduce the use of it. Provider FNP attempted to follow up with patient via phone. Received no answer and left voice mail message x2. Patient has not returned calls.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Additional information: Caller is a 77 years old, male patient, positive to Covid; he reached with a question regarding Paxlovid. Caller stated that his risk factors included Age and medical conditions that makes him immunocompromised. Caller mentioned to have COVID even though he had his 3 doses of Pfizer Covid Vaccine. Caller reported to had been in contact with pharmacies and that nobody seemed to know if Paxlovid was available. Caller asked for the availability of Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
my 14 year old daughter started vomiting the night of her Gardasil vaccine and was vomiting all through the night and the next morning. She is still vomiting now.