chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a female subject of unspecified age who was vaccinated with influenza vaccine quadrivalent (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine Quadrivalent (unknown route and injection site; lot number not provided). Within 20 minutes after vaccination with Influenza vaccine Quadrivalent, the subject experienced extensive swelling of vaccinated limb, the injection site was red, hot and painful. At the time of reporting the injection site had a swelling of approximately 11 x 6 cm in size and it was still warm and pink. At the time of reporting the events were unresolved.
Information has been received from an unidentified source at a physician's office concerning a patient who was vaccinated with Varivax (Oak/Merck). Three years after vaccination with Varivax (Oak/Merck) the patient experienced breakthrough chicken pox. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Narrative:  Patient had fever and sent to ER. Patient tested positive previously for COVID and became unresponsive. Admitted 8/23/21 for acute hypoxic respiratory failure and started treated of dexamethasone, enoxaparin, and baricitinib. Regained consciousness 8/23/21. Developed secondary bacterial pneumonia and treated with antibiotics. Patient deceased 9/10/21 from cardiopulmonary arrest secondary to COVID-pneumonia.
Employee received flu vaccination 9/26/11 about 16:30PM. Employee states "woke up next morning with severe pain in my left arm; pain began to move into neck and shoulder over next few days and then began to have back pain and chest pain. Requested she take anti-inflammatory. Sent to worker's compensation physician 10/10/11 who ruled out work related injury status post flu shot.
It has been rec'd that a pt with an insignificant medical history and no allergies who on 1/18/02 was vaccinated IM in the L arm with hepatitis B vaccine recombinant. Concomitant vaccinations included a rabies vaccine which was received on 1/18/02 and 1/25/02 in the L deltoid (lot#T0880). On 1/26/02 the pt experienced flu like illness ( chills and questionable fever), and muscle soreness which was mainly at the injection site. The pt's lymph node under her L arm swelled significantly and a lymph node on the L side of her neck became hard, swollen, and tender. The pt also experienced L sided neck tenderness. It was reported that all of the symptoms resolved in 3 days. At the time of this report, the pt also experienced pain in the upper part of her back when she turned left. At the time of this report, the pt had little residual pain with definite improvement. Unspecified medical attention was sought. Follow up and conflicting information has been rec'd from a RN who reported that on 1/18/02, the pt was vaccinated with the 1st dose of hepatitis B vaccine recombinant in the R deltoid (lot#641072-1164L exp:06/04/04). On 1/18/02 and on 1/25/02 the pt was vaccinated with the first and second doses of rabies vaccine (INOVAX RABIES VACCINE) in the L deltoid (lot#T0880). There were no other concomitant medications and no illness at time of vaccination. It was reported that on 1/26/02, the pt experienced flu like symptoms, chills, felt hot and cold, swollen and tender lymph nodes under the L arm and L side of neck times 3 days and the L side of her neck hurt. On 1/28/02 the pt's upper back by the top of her spine hurt. The nurse reported that the pt did not seek medical attention. The pt subsequently recovered from the flu like symptoms, chills, hot and cold feeling, swollen and tender lymph nodes under the L arm and L side of neck, L neck pain and back pain. It was also reported that there was no subsequent reaction on additional vaccinations with hepatitis B vaccine recombinant (details pertaining to the subsequent vaccination were not provided). No further info is expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt reported feeling faint 2 minutes after vaccination, pt became dizzy, lightheaded, and fainted.  pt did not fall or injur themselves, technician observer and pharmacist were in view of the patient during the event.  we layed the patient down on the floor and put her feet up and checked her blood pressure (100/70, low per pt hx).  pt recovered after 3-4 minutes, but layed on the floor for an additional 15.  pt then sat in a chair and fully recovered and sat for 15 minutes.  no injuries reported
Information has been received from a Registered Pharmacist (R.Rh.), concerning a 72 year old female patient. The patient had no known drug allergies. On 17-SEP-2012, the patient was vaccinated subcutaneously in the left arm with a 0.65 ml dose of ZOSTAVAX (lot #: 0565AE; expiration date 23-SEP-2013) There were no concomitant medications. On 19-SEP-2012, the patient experienced a mild fever, swelling, warm to touch, and redness at the injection site. Patient sought medical attention by calling the pharmacy and on 20-SEP-2012, patient went to the pharmacy and the swelling of left arm had gotten bigger and was still red, but the fever had subsided. Pharmacist stated it was normal for the patient to react like that after getting a vaccination. At the time of the report, the patient had not recovered from swelling at the injection site, warm to touch and redness at the injection site and was recovering from mild fever. The relatedness for mild fever, the swelling at the injection site, redness at the injection site and warm to touch at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Pt. did not report the reaction right away or sooner. Stated "started" as blister on the top of the injection site. He pinched it to drain the fluid. No signs of injection but left a black scar. Felt little feverish. 10-11-11 pt informed of reaction to the nurse.
3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms.  3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain  4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.
Pt vax; devel red, tender, indurated inject site.  7cm in diameter.
Was told she would get a rash 10 days after shot. Fever started on 08/29/14 finally broke 09/01/14. Rash all over body 08/30/14 until... still has.
Moderna on 2/5 and 3/8. Positive on 9/11
11 days post vax the pts arm was reddened and warm to the touch with a noticeable nodule under the skin. Two days later the pt developed three pin head vesicles at the injection site and two small blisters on her back. Reportedly 3-4 days later the vesicles ruptured and the skin began to slough off on arm. It was reported that the vesicles were much smaller than expected from chickenpox. The area appeared reddened and swollen for 16 days. It was reported that the pts varicella IgG was positive. Follow up information indicated that the pt experienced what was probably chickenpox and may have been a result of the varicella virus vaccine live.
Report blister filled lesions in clusters right side of face and forehead that is painful to touch. Treatment: None Outcome: Recommend EE be seen by PCP to rule out shingles. Does not interfere with ADLs.
Pt was given Pfizer vaccine when she was 11 years old.  No adverse events reported.  Pt has since turned 12 and received another Pfizer vaccine.
Patient experienced redness and inflammation at the injection site that gradually worsened and spread to wider area over three day period. She received her Prevenar and SHINGRIX injection at the same time on 9/25/21. She was told by the injecting pharmacist that SHINGRIX will given administered in her left arm and Prevenar in her left arm. The reaction is on her left arm, but not on her right arm. She has been taking Ibuprofen once daily and Benadryl 1 tablet once daily with no improvement. She came to pharmacy for advice. She is advised to take ibuprofen 1 tablet every 6-8 hours with food and Benadryl 1 tablet every 4-6 yours. She is to seek medical help symptoms do not improve or worsen within the next 24 hour period.
Product beyond use date was 11/9/2022 and this product was used on 12/8/2022.  Writer contacted Pfizer and CDC for further guidance.  No adverse reactions expected, advised to repeat dose ASAP.
Migranes every single day some so painful I can't function on some days. Can't concentrate or remember alot of things, no energy, I'm so tired. My chest always feels tight and heart rate is very high.
hepatocellular pattern of liver injury; This is a literature report for the following literature source(s): "Liver injury following SARS-CoV-2 vaccination: A multicenter case series".  A 73-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "chronic liver disease" (unspecified if ongoing); "autoimmune hepatitis" (unspecified if ongoing), notes: in treated remission. The patient's concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". Timing of presentation (days) Pattern of injury in relation to first dose of vaccine is 6 days. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 813 IU/l; blood alkaline phosphatase: 114 IU/l; blood bilirubin: 0.7 mg/dl; international normalised ratio: unknown results; laboratory test: no abnormal labs, notes: for a minimum of 6 months. Therapeutic measures were taken as a result of liver injury with Oral prednisone. The patient with autoimmune hepatitis (AIH) in treated remission (i.e., no medication changes or abnormal labs for a minimum of 6 months). The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient
3DEC92 Pt vax & w/in 2 hrs, pt presented to the ER w/generalized urticaria;
no adverse event; a 34 year old male was administered PROQUAD on 5/4/2022; This spontaneous report was received from a registered nurse, referring to a 34 years old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 04-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, quantity 1, lot # u029147, expiration date 16-MAR-2023; strength and route were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AEs) or product quality complaint (PQC) reported.
At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98,At 10:24 BP 164/102, At 10:27 BP 167/99; Unable to work after the 2nd dose; I wasn't able to go back to work because of severe weakness; Dizzy; my BP went down to 90/60, 80/56; This is a follow-up spontaneous report from a contactable Nurse in response to HCP letter sent in cross referenced case. A 49-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in deltoid right on 14Jan2021 at 09:00 (at age of 49 years old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 20Dec2020 as single dose for Covid-19 immunization. On 14Jan2021, the patient was placed on close monitoring after receiving the second dose for continuous pulse oximetry, O2 saturations ranged from 98%-100%. At 09:50 BP 157/98, HR 73, 99% O2 sat, then 09:51 BP 161/101, HR 100, SpO2 100%, at 08:58 am 167/80, HR 85, SpO2 94%. The PCP prescribed clonidine 0.1 mg as needed for SBP>160. The patient took 1 tab clonidine 0.1mg. At 10:13 BP 181/93, HR 63, SPO2 100%, at 10:22, BP 165/98, HR 59, 100% SPO2, at 10:24 BP 164/102, HR 77, 99% SPO2, at 10:27 BP 167/99 HR 74, 100% SPO2. Later the patient took 2nd dose of clonidine 0.1mg and at 10:36 BP 134/86, HR 65, SPO2 100%, at 10:47 BP 124/81, HR 65. The patient was released by employee health nurse. She was dizzy when she got home, her BP went down to 90/60, 80/56. The patient was unable to work after second dose because of severe weakness. The patient stayed in bed for 5 days. The patient went back to work on 19Jan2021. Treatment for the event blood pressure fluctuation was two dose of tab clonidine 0.1mg. The patient provided information regarding the reported adverse events with the use of the suspect product to the nurse and the nurse considered that the Pfizer product had a causal effect to the adverse event. The outcome of the events was unknown.  Information on the batch number has been requested.
Pain in the muscle. Later in the day, pain and slight swelling developed in the lymph node under left arm pit. Took 200mg Ibuprofen. The pain generally resided the next day.
I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 8 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
PATIENT REPORTED WARMNESS TO TOUCH AND A COUPLE BUMPS THAT APPEARED TO BE HIVES ABOUT 2 DAYS AFTER RECEIVING FLUZONE HD. PATIENT WENT TO URGENT CARE AND RECEIVED A STEROID INJECTION AND A STEROID PACK.
Client received Menactra on 8/8/05. On 8/9/05 upon awakening client experienced some nauseated and left sided numbness. Reported it to health dept who instructed to be seen by doctor. Dr sent to ER. 08/16/2005:  Telephone follow up with reporter who was informed by the patient's mother today that the numbness abated completely within 2 days and was noticeably less by the end of day one.  No further medical intervention was required.  The reporter state that the mention of GBS was based only on the mother's recounting of the comment dame by the ER doctor.
102 FEVER, CHILLS, SWELLING, SEVERE HEADACHE TREATED WITH TYLENOL ALTERNATING WITH IBUPROPHEN SYMPTOMS REDUCING AT 24 HRS SWELLING STILL PRESENT
6MAR98 pt devel vesicular rash w/low grade temp;approx 40 lesions noted;
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 28-JAN-2014 the patient was inoculated with ZOSTAVAX vaccine at a clinic for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 07-JUL-2015 the patient was treated at a clinic for onset of a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
This spontaneous report has been received from a medical assistant and an administrator refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M031807, expiration date 02-APR-2018; dose and frequency were not reported), orally, for prophylaxis. The vaccine data logger measure a temperature range from 32°F to 35°F (0°C to 1°C) for a total time frame of 1 hours (1 cycle) on 24-JAN-2017, 3 hours (3 cycles) on 25-JAN-2017 and 4 hours (4 cycles) on 26-JAN-2017 for a total of 8 hours (8 cycles). The medical assistant mentioned that the vaccine was exposed only for 1 hour and 30 minutes at a temperature as low as 33.1°F, the other cumulative hours were at 34°F. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001785: US-009507513-1704USA001786: US-009507513-1704USA001784:
I have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covide19 shot I got my period; headache; dizzy; nauseous feeling; arm pain; 2 days after the first dose of the covid-19 shot got her period; This is a spontaneous report from a non-contactable consumer (patient) .A 52-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Mar2021 (at the age of 52 years old) at a single dose for COVID-19 immunisation. The patient medical history included High Cholesterol and Statins allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient received historical vaccine Shingrix on 05Feb2021 in two weeks of vaccination. Concomitant medications included Celecoxib (CELEBREX), fish oil, Colecalciferol (VITAMINE D), Zinc, Probiotics. On 06Mar2021 the patient stated not some much as a reaction but have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covid-19 shot got her period. The shot did cause headache, dizzy, nauseous feeling, arm pain as well for about 2 days so far. No treatment was received. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pneumonia vaccine (yearly from 1996-2019); This spontaneous report was received from a 39-year-old female patient, concerning to herlself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified dates from 1996 to 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administration).  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2002USA001316:
Walk; Feeling sick; Nausea; chills; fever; little bit chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE, MALAISE, PYREXIA, CHILLS, and NAUSEA in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19. Concomitant products included ASPIRIN, ATORVASTATIN, and DICLOFENAC for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA and CHILLS. On 09-Apr-2021, the patient experienced GAIT DISTURBANCE, MALAISE, NAUSEA, and CHILLS. At the time of the report, GAIT DISTURBANCE, MALAISE, PYREXIA, CHILLS, NAUSEA, and CHILLS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC-MOD-2021-073717. Sender's Comments:  US-MODERNATX, INC-MOD-2021-073717: Second dose.