chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was in observation waiting his 15 minutes when he stated he started felling dizzy. He then went into a syncopal episode and started having seizure like movements. The nurses onsite assisted the patient to the floor to prevent any injuries. After about 5 minutes the patient came to. As EMT was being called the nurse assessed the patient blood pressure and other vitals which read as the flowing BP 176/86 , RR 19 , HR 83. The EMT team arrived on site around 2:15 and assessed the patient. The EMT's did a 12 lead  on the patient and noticed some elevation in his heart rhythm and told the patient that he recommends  he go to the hospital the patient refused and went home instead.
Flu vaccine given 11/23/2018-no reaction or adverse event Patient reported had mandatory flu vaccine 10/14/2019, contacted employee health nurse1/7/2020 that she continues to have left shoulder pain from flu shot in her arm/shoulder area. States left side arm/shoulder: tender, hurts, does not impact her work, does wake up at night with pain. Taking Naprosyn over the counter per MD recommendations 1/15/2020. Doing home exercises. There is not anything phusical to see where the injection was given.
Patient received PNEUMOVAX 23 (Lot # 0623Y exp 12/1/10) in right deltoid intramuscular on 7/13/10. He states that 30 minutes afterwards, pain and erythema began, which increased throughout following day. Injection given at approx. 5PM 7/13/10. Came to office 7/14/10 at 5PM with tenderness, erythema and induration of right upper arm above elbow but below shoulder joint. Temperature 100.8 arm and axilla area painful. Prescribed VICODIN for pain and KEFLEX. Seen again in office 7/15/10. Arm remains red, afebrile, has follow up for 7/19/10. Merck notified
c/o itching and pressure in her head. Narrative:  c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.
Hospitalized;  COVID-19 positive (9.5.21);  fully vaccinated Admission Date: 9/6/2021 Discharge Date: 09/08/2021 Patient's Discharge Disposition:  Home in stable condition. DISCHARGE DIAGNOSES:   1. Sepsis, UTI 2. Non-neutropenic fevers 3. Covid-19 positive 4. AKI 5. Metastatic neuroendocrine carcinoma of Retroperitoneal Mass with pelvic lymph mets 6. Metastatic invasive urothelial carcinoma  7. HTN 8. HLD 9. Insomnia Hospital course:   This is a 69 yo male with a history of neuroendocrine carcinoma of pelvis mass diagnosed 7/8/21 and on active treatment with VP16/cisplatin. He completed cycle 2 on 9/2/21. He also has a history of urothelial carcinoma s/p RURBT 3/22/19 and cystoprostatectomy 11/2020, CAD, OSA, HLD. He had presented to Metro ED on 9/5/21 with a fever, nausea and malaise. Work-up was started with blood cultures, IV antibiotics but the patient eventually left AMA due to bed shortage from Metro. Then on 9/6/21 he presented to SH BWH ED. He had  Leukocytosis and fevers. His COVID PCR from 9/5 was positive. The patient was admitted for sepsis, likely from COVID-19. UA appeared positive and urine culture is still pending. Patient was started on Zosyn. ID was consulted for evaluation. The patient did not meet criteria for monoclonal antibodies for Covid. His fevers improved and his blood cultures are negative at 48hrs. Per discussion with ID patient is okay to discharge home today, and with zosyn has been treated for UTI, although cultures will be followed-up outpatient. The patient had diarrhea but it improved prior to cdiff sample could be collected. He had a mild AKI on admission which has improve with IVF. The patient's WBC normalized and his vitals are stable. He is discharging home in stable condition. He will follow-up in the office on 9/16 with labs and Doctor. Nurse coordinator to f/u on urine culture after discharge.
Swollen Lymph Node under right armpit noticed 3 days after injection. Headache with dizziness and nausea beginning  7 days following injection. Lasting so far for 3 days.
Severe facial itching and swelling around the mouth. 12/22/06 Received medical records from hospital which reveal patient seen 11/20/06 with complaints of swollen itchy lips & painful chin day after flu vax 11/15/06.  Patient had taken Benadryl w/o relief.  Lips were noted to be reddened, had papules & were swollen.  No respiratory distress.   FInal DX: allergy to FluMist vaccine.
Case number PHEH2015US026913, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 21-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. No adverse reaction was experienced by the patient following the medication error. Reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day, and when she arrived the next day and the temperature was fine. It was a new refrigerator, and there have not been any problems since the temperature excursion. No further information provided. Follow up information was received from a nurse on 26 Jan 2016. Nurse comment added.
Immunization Nurse at Clinic calls FBVHC who presents to clinic on 15JULY11 with erythema & warmth "going all the way around her upper arm" at AVA #7 injection site. FBVHC NP speaks directly with patient who reports receiving AVA #7 in her LUE at 0715 on 13JUL11 at Aid Station. SM denies any fever, systemic malaise, HA or joint pain. She states that the area surrounding her AVA injection site on her left upper arm is red, warm to touch and itches." The area of redness is about the size of an orange and wraps around toward the front of her arm. SM states that this has never happened before with any prior doses of the AVA. She remembers the injection site becoming "a little hard" but never developed any redness, swelling, warmth or itching. She is not in any pain and the ROM of her left arm is not restricted or hindered. She denies any axillary LAD or left shoulder pain.
Red and pimple like bumps some itchy noticed today June 9, 2006. Treatment Acyclovir 800mg qid x 5 days.
COVID-19 Booster Dose; chills; muscle aches; headache; lymphadenopathy; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID-19 Booster Dose"; CHILLS (non-serious), outcome "unknown", described as "chills"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown", described as "headache"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymphadenopathy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I felt perfectly fine prior to getting this Johnson and Johnson injection. I wish I never got it. I have had a horrible nagging cough since having this shot. I got the shot on 3/14/21 ... it is now 1 month later and I still have it. I can be talking fine and then all of a sudden cough. I cough all day and all night. I never should have gotten this vaccine.  My cough will not go away. I am in the healthcare field which is why I got this injection and now I regret it. I also tested POSITIVE to COVID 1 week after getting the shot. I lost all sense of taste and smell and felt horrible. I got tested for COVID on 3/21 and found positive.
a little rash appeared on her upper right arm; burning sensation in the abdomen; gastritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for COVID-19 Immunization; Bnt162b2 (Dose: 3rd), for COVID-19 Immunization.  The following information was reported: GASTRITIS (non-serious) with onset Oct2022, outcome "recovering"; RASH (non-serious), outcome "unknown", described as "a little rash appeared on her upper right arm"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "burning sensation in the abdomen".  Additional information: Caller provided that she was diagnosed with gastritis in fall of Oct2022 and provided that the burning sensation she was feeling "seemed to have gone away." Caller provided that her gastritis has "somewhat resolved itself." Caller stated that she was "diagnosed with COVID this past Monday, however on Sunday (when she was not COVID positive), a little rash appeared on her upper right arm, in which she assumed it was shingles or a staph infection." Caller stated that she was taking Valacyclovir but she "took herself off of it upon starting Paxlovid yesterday morning." Caller provided that she is vaccinated with "2 Pfizer boosters and was on route to getting her bivalent" until she came down with the rash and exposure to COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received COVID vaccine at 10:00am. Patient presented with symptoms of lightheadness and sweating within the 15 minutes of monitoring. Patient given water and stayed about 15 minutes more (30minutes total). Pharmacist on duty offered to call 911 but patient said he was feeling better. At 6:00pm mother called pharmacy and said son went to ER due to difficulty swelling.
red raised area on face @ 2PM-alcohol placed on area & dec in size; 5PM red raised areas covering face, arms & legs; 530PM seen @ hosp t101 dx hives;
Pt developed an increase in oxygen needs  throughout hospital stay and was never able to wean from vent. Increase in difficulty oxygenating appears to begin  most around 11/17/21. Pt also battled MDR infections/sepsis during stay.
First dose of vaccine was administered on 2/2/21 Pfizer LOT#EL3302 2nd Dose administer was Moderna listed above  For first dose patient filled in for a cancellation, Local facility has not been allocated any extra single doses.  Patient wished to get 2nd dose of Moderna due to another cancellation.  Patient did not wait for uncertain amount of time for 2nd dose of Pfizer.
Flu like symptoms, body aches, fever, loss of appetite, severe stomach & back pains, chills with extreme sweats,  period 3 times since first dose this is most concerning
Immediately after the injection, I tasted a strange taste near the back of my throat near the sinuses.  I don?t know but I want to say maybe a little metallic.  My nose/sinuses seemed to drain immediately.  Later on in the day I was very tired and slept.  The second day after the injection, I developed sharp shooting pain in my arm pits both left and right arm pits.  Felt tender.  This lasted for two days and then seemed to go away.
I have sarcoidosis and the vaccine has kicked me into a bad flare-up.  I have a large granuloma growing under the skin on my right arm near the wrist.  I started noticing it last week because my skin is very tight around it.  I did not have this before.  I have, however, had a granuloma removed from that wrist about 10 years ago.  This is above where that was though, not the same spot.  The granuloma is hot to the touch.  I have felt horrible since I got the shot and I am  extremely fatigued.   I  have had to miss work because I slept past the alarms.   My body hurts all over still.  I'm most concerned about the immune response and the thing growing on my arm.
She called this am 9/13, said she got real nauseated last night, vomiting. could not eat anything. She sais she thought it was form the vaccines. She said she was probably going to urgent care if did not feel better in a few hours. I told her it was possible one of the vaccines had made her sick. said her arm was a little sore. I told her I would follow back up with her in a little while, and for her to let me know what MD says if she ends up going to the clinic.
Jittery and involuntary muscle movements. Chills.  Dizziness when I would try to lay down. Nausea followed by abdominal pain. Dry heaving. Later in the day I developed a headache. Resolved at 11pm that night.
Narrative:  Covid +, pneumonia, SOB, Received Moderna 3/1/21 and 3/30/21. remdesivir, Decadron. discharged to home
pt recv vax MAR97 & on 20FEB98 pt devel chickenpox;pt recovered;
Patient tested Covid positive, cough, low oxygen levels, COVID Pneumonia, patient is now deceased
Started feeling hot, dizzy, achy. Temp was 99.3 at 6pm. Took Advil, 1 tab. at 7:30 pm temp was 100.1
Pt recvd HIBTITER/OPV & w/in minutes exp red blotchiness on both legs & stomach which lasted 15 min & then disappeared; not urticaria;
Sick for 2-3 days with headache and fever; Sick for 2-3 days with headache and fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Sick for 2-3 days with headache and fever) and HEADACHE (Sick for 2-3 days with headache and fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Immunosuppression (Arthritis). Concomitant products included ETANERCEPT (ENBREL) for Immunosuppression. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Sick for 2-3 days with headache and fever) and HEADACHE (Sick for 2-3 days with headache and fever). At the time of the report, PYREXIA (Sick for 2-3 days with headache and fever) and HEADACHE (Sick for 2-3 days with headache and fever) had resolved.    Patient stated that there were no side effects with 1st dose. No treatment medication was provided. This case was linked to MOD-2022-669885 (Patient Link). Reporter did not allow further contact
Following injection of DTP/HIB. Pt began running inc T of 104 & higher & starting wheezing
Local arm pain, achey, feverish, insomnia, HA, gum pain, aches all over. Pt was advised these symptoms can happen with SHINGRIX. 09-07-18 per patient she is feeling so much better today.
pt recvd vax;dad checked pt 24sep at 1am,blood in mouth & nose; pt blue & not breathing;to er & pronounced dead at 2am;er report,death certificate & autopsy report to follow;
Cellulitis, swelling of the left arm and whole left side of legs. Pain, Fever, tachycardia. body ache reported by Mom.
Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, her son experienced toxic neurological effects of mercury poisoning. Outcome is unknown. Toxic neurological effects and mercury poisoning were considered other important medical events (OMIC). No additional information was provided. This report was received from the manufacturer's legal department on 12/13/04.
papules and vesicles in various stages at evaluation. RX: Benadryl, aveeno baths, and topical neosporin.
Information has been received from a physician concerning a 12 week old female with a history of being born prematurely at 36 weeks who on 29-MAR-2007 was vaccinated with Rotateq PO first dose. On 25-APR-2007 the patient developed fever, abdominal cramping, jelly like stools, 27 days after receiving her first dose of Rotateq. The patient was evaluated in the emergency room an it was determined that the gastroenteritis was not due to rotavirus. Hospitalization was not required. The symptoms subsided after one to tow days, on approximately 27-APR-2007 and the patient is now fully recovered. Additional information is expected.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 9947M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This product has been exposed to temperature outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This customer purchased one 10 pack of this product therefore it was administered to 10 patients. the ages and genders of the patients are unknown at this time. This case is one of the 9 cases reported by the same reporter for the same vaccine.
This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar event for five patients. This is the truth of five reports. A patient (of 2, 3 or 4 years of age and gender unknown) received a dose of PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a skin reaction and skin swelling. The pediatrician reported that one of their practices was seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds with the vaccine. The skin reactions were greater than 25 inches in diameter and they were seeing approximately 5 children a week with this type of swelling. The outcome of the events were unknown.
blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs  headache
DIFFICULTY BREATHING; SORE THROAT; SWELLING OF THE  THROAT; FEVER; SORE ARM; This spontaneous report received from a parent concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the subject experienced difficulty breathing. On 22-MAR-2021, the subject experienced sore throat. On 22-MAR-2021, the subject experienced swelling of the throat. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, swelling of the throat, fever, and sore arm, and the outcome of difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
reddish bumps and rash on stomach. chest. back and right arm. no rash or swelling at site of injection.
Wrong Route of Administration; Injection site knot; Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 1st February 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site lump and injection site pain. On an unknown date, the outcome of the injection site lump and injection site pain were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site lump and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine on her left arm underneath the skin as a subcutaneous injection, which led to intramuscular formulation administered by other route. The patient developed a knot and pain at the injection site on left arm which lasted for 4 days. The reporter consented to follow up. No further details were provided.
Pt got a Moderna booster IMZ on 11-24-21 by pharmacy technician. The pt called the pharmacy on 11-26-21 and said that the arm where she got the IMZ in was red, hot and hard. She said that the redness started to develop about 4 hours after she received the IMZ. When she called today she said that redness has increased in size. I asked her if she had taken anything and she had taken ibuprofen for the pain. I had asked if she had a fever and she said she did not. I had recommended she get it looked at by medical professional but she declined that recomendation.  I had recomended in the mean time to use cold compress every 10 to 15 minutes and to take ibuprofen. I told her if it got more severe or she had a fever to seek medical attention.
Administered on 10/15/13, but still has large area of redness at injection site. Initially was itchy but not anymore.
5 minutes after receiving the vaccine, during the 15 minutes observation time, patient had a syncopal episode that lasted for less than 1 minute. Patient did not loss consciousness, he was alert and oriented to person, place, time and event but he  was diaphoretic and pale, BP: 100/70, HR: 58, O2 sat: 98, RR: 18.  Patient was then observed for another 30 minutes in the clinic, at which time HR: 88, O2 Sat: 98, BP: 110/76, he was no longer diaphoretic or pale. Patient was discharged home and advised to follow up with his PCP.
expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 7th of 8 patient.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed.  Information about Lot/Batch number is requested.; Sender's Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose
pt recvd vax & devel macular erythema w/ multi bullae to rt temple; mid-sternum; rt lat thigh red edematous circular at inject site;