chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; fever; pain at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 30th September 2021) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced chills, fever, injection site pain and injection site swelling. On an unknown date, the outcome of the chills, fever and injection site pain were recovered/resolved and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the chills, fever, injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of Shingrix on the left arm and experienced chills, fever, pain at the injection site, swelling at the injection site to about one third size of an egg.  The patient reported that chills, fever and pain had resolved.
Fever to 103 degrees F about 12 hours after seasonal flu vaccine. Also, mild redness @ injection site. Responded to TYLENOL.
Heart palpitations, severe tremors, dysesthesia, dizziness, shortness of breath, squeezing and pounding chest pain, restless arms and legs, numbness, loss of coordination, swollen lymph nodes (softball sized starting in the under arm on the side of the shot, moved elsewhere in time)...diagnosed shortly after with heart damage from cardiac inflamation, PVC, PAC, mitral valve regurgitation, irregular T-waves. Amenorrhea (nearly no period) for ten months, followed by irregular periods with severe dysmenorrhea - not in peri or menopause, family history of children born late in life and menopause not until 50s. Onset of several autoimmune disorders in later months - MCAS skin rashes, severe arthritis, new food/chemical sensitivities.
A report was received from a health professional on 10/15/02, concerning a 34 year old male patient who experienced pinching chest pain and neck pain after receiving Fluvirin on 10/14/02. the patient had been in excellent health and has no known drug allergies. At 09:15 on 10/14/02, the patient experienced pinching chest pain and neck pain, after receiving the Fluvirin vaccine 15 minutes earlier. The patient complained of severe pinching  chest pain on the upper left chest and severe pain on the left side of the neck. The patient had a weak pulse and was admitted to the ER. At the time of the ambulance arriving the patient's heart rate was 146/100. At the ER the patient was given four tablets of aspirin and one tablet of Nitroglycerin which relieved the chest discomfort. On the same day, the patient recovered and was discharged from the ER. The reporter has assessed the relationship of study medication to the event as possible.
Patient received vaccine at hosptal.   Presented to ER on 3/9 due to shortness of breath. Patient received vaccine the day prior (3/8). Patient states that shortness of breath started a few hours after COVID vaccine. Dx in ER: Acute on chronic CHF, Dyspnea, elevated BNP level, acute resp failure with hypoxia. H&P states that patient felt fever, chills, N/V, joint pain and shortness of breath. CXR had bilateral opacities/pleural effusion- likely pulmonary edema.   Patient is still currently admitted- appears more related to fluid overload/CHF.
At time of the second shot, immediately after receiving it, I felt what I can only describe as a sizzling feeling through the top of my head and my heart clenching.  I got dizzy and just leaned back and started breathing slowly. I assumed it was nerves and worked through it.
Recurrence of melanoma- cancer found in R axillary lymph node; treatment: surgery, immunotherapy; outcome: ongoing immunotherapy
first vaccine: a week after shot: intense pain at vaccine shot and red rash that lasted 5 days second vaccine: chills, 101 fever, 2 large  itchy   rashes on back:  (one with blisters)1 gone by next day,  blistered patch still raw red a week later. 3rd back rash with blister developed 5 days after vaccine
Erythema of area where vaccine administered, local reaction, Claritin prescribed w/ good effect.
Patient came in for a varicella vaccine, per system he didn't receive his 2nd varicella.  Per vaccine record patient had an MMRV on 02/27/15. No adverse reaction occurred, was given an extra varicella.
Initial report received on 03 December 2007 from a health care professional. An adult patient with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received a subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reporter for this case is the same as for cases 2007-04169, 2007-04171, 2007-04172, 2007-04173.
Information has been received through a pregnancy registry from a 32 year old female with a sulfa allergy with a history of 2 pregnancies; one birth and one miscarriage who on 10/7/04 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included ascorbic acid (+) beta carotene (+) calcium carbonate (+) carbonyl iron (+) cholecalciferol (+) copper (unspecified) (+) docusate sodium (+) folic acid (+) magnesium oxide (+) vitamin B complex (+) vitamin E acetate (+) zinc oxide. On 10/12/04 the patient discovered she was pregnant. A pregnancy test was done. Unspecified medical attention was sought. On 10/15/04 the patient had a miscarriage. Follow up information from the RN indicated that the pt had a complete spontaneous abortion on 20Oct04, 6 weeks from her LMP. No further information is expected. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
GARDASIL # 1 given 11/19/08. On 11/21, pruritus and papular red rash. Low grade fever. Have hx. of allergic reaction to PCN, Sulfa, Bee stings and pertussis vaccine.
Case number PHEH2013US012433, is an initial spontaneous report received from a consumer on 05 JUN 2013. This report refers to a 48-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with Men A component on 05 JUN 2013. He stated that, he saw the liquid and powder vials in the box and a statement that they needed to be mixed before administration, but the person who administrated did not mix the vaccine. No adverse reaction was reported following this administration error.
Previous dose of Covid19 vaccine was Pfizer on 1-14-21. Vaccine administered today was Moderna as that's what was available at today's clinic.
soreness of the left arm; headache; coughing; nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the left arm), HEADACHE (headache), COUGH (coughing) and RHINORRHOEA (nasal drip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced PAIN IN EXTREMITY (soreness of the left arm), HEADACHE (headache), COUGH (coughing) and RHINORRHOEA (nasal drip). At the time of the report, PAIN IN EXTREMITY (soreness of the left arm), HEADACHE (headache), COUGH (coughing) and RHINORRHOEA (nasal drip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitants were provided.
Intermittent coughing and fatigue. Pt c/o chest pain, pain to right arm. Pt was monitored for 1.5 hrs.
Local site swelling and pain, chest pain and shoulder pain. Pt had to go to ER
For days 1-7, post-vaccine:  Headache, fatigue, joint pain, severe.  For days 14-16 post-vaccine:  Fever, 101.1-101.4, severe joint pain, headache  For days 17-19 post-vaccine, severe joint pain  Day 20 post-vaccine, moderating joint pain, hopefully recovering, but uncertain whether or not symptoms will reappear.  Joint pain was most severe in fingers, elbows, shoulders.  It even affected my "good" knee.
Information has been received from a registered nurse concerning a 25 month old white female with no medical history or allergies who on 14-MAR-2006 was vaccinated SC on the right arm with 0.5 ml first dose of Proquad (Lot # 651815/0950R). At the time of vaccination the patient did not have any illness. There was no concomitant medication. On 17-APR-2007 the patient developed a rash. The patient was seen by the physician on 19-APR-2007 and rash was reported as "red based areas with questionable blisters, no crusting, no itching, no discomfort, no drainage noted". The patient had not experienced any fevers. The patient was referred to a dermatologist and was seen on 20-APR-2007 and rash was reported as "chicken pox". Number of lesions on arms and back were not noted by nurse. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that on 17-APR-2007 the patient developed rash on arms and back. The rash was non-pruritic which spread to face, legs, chest. The number of lesions were too numerous to count on arms and legs. There were fewer lesions on face, chest and back. The patient was afebrile but did not act ill. The lesions were described as red based papules blister with no crust. On 19-APR-2007 patient was seen by a physician and was referred to a dermatologist who confirmed varicella as the diagnosis and prescribed "Exoclin". No diagnostic laboratory tests were undertaken. On 24-APR-2007 the patient was recovered. The patient had no adverse events following prior vaccination. No further information is expected.
Headache, Myalgia & Fever Narrative: Per supervisor report: "received vaccine 4/6/21 c/o headache, fever, body aches"
COAGULOPATHY, UNSPECIFIED TYPE 12/15/2021 HYPOTENSION 11/14/2021 COAGULOPATHY, UNSPECIFIED TYPE 12/15/2021 HYPOTENSION 11/14/2021 COAGULOPATHY, UNSPECIFIED TYPE 12/15/2021 HYPOTENSION 11/14/2021 COAGULOPATHY, UNSPECIFIED TYPE 12/15/2021 HYPOTENSION 11/14/2021 COAGULOPATHY, UNSPECIFIED TYPE 12/15/2021 HYPOTENSION 11/14/2021
Pain on leg, numbness in crotch, face, mouth, arms, feet and rectum. Burning in feet, down inside of legs, testicles, sharp jabs of pain in chest, cold sweats, tired, light-headed, queasy sick, joint pain in all joints, headaches and numbness all over. All symptoms come and go from day to day. Symptoms have been less and milder since March 2000, but still have all the symptoms, to this day. (no treatment) 60 day follow up states patient experienced burning across shoulders, down arms, and hands. Patient has tingling in face and top of head and stomach pain.
I26.99 ACUTE PULMONARY EMBOLISM 7/19/2022 AV BLOCK, COMPLETE R09.02 HYPOXEMIA 6/18/2022 AV BLOCK, COMPLETE I26.99 ACUTE PULMONARY EMBOLISM 7/19/2022 AV BLOCK, COMPLETE R09.02 HYPOXEMIA 6/18/2022 AV BLOCK, COMPLETE I26.99 ACUTE PULMONARY EMBOLISM 7/19/2022 ANEMIA R09.02 HYPOXEMIA 6/18/2022 ANEMIA I26.99 ACUTE PULMONARY EMBOLISM 7/19/2022 COMPLETE SMALL BOWEL OBSTRUCTION R09.02 HYPOXEMIA 6/18/2022 COMPLETE SMALL BOWEL OBSTRUCTION I26.99 ACUTE PULMONARY EMBOLISM 7/19/2022 PARTIAL COLON OBSTRUCTION R09.02 HYPOXEMIA 6/18/2022 PARTIAL COLON OBSTRUCTION
Approximately 11 days after the vaccine, I started developing massive itchiness to my entire back.  I had no changes in diet, medication, or environmental contact.  I took a zyrtec that night slept fine and woke up the next morning with continued massive itching and hives throughout entire body with face swelling and minimally hard time breathing (felt as though I could not get a good breath in).  I was able to get an appointment with my dermatologist who recommended first line antihistamines prior to starting steroids.  After the visit, on that Wednesday morning, I took two claritins.  The massive itch continued throughout the day with rash and hives throughout entire body.  That night I took a benadryl, slept well again.  Woke up with continued extreme massive itching and hives throughout body.  At this time, my face was no longer swollen and breathing felt fine.  I was able to get an appointment with my allergist on Thursday afternoon.  From there, I have been started on prednisone and instructed to take two zyrtecs once in the morning and again at night.  Currently it is Friday, I took my first dose of 40mg prednisone yesterday.  I still am itchy but nothing as severe as before.  The hives have also decreased.
Sharp pain in ear that comes in goes morning after shot that lasted two days. Slightly swollen front inner part of right shoulder (NOT the arm that was injection) just outside bra strap, two days after shot up to present. Right arm also felt tingly. I took Ibuprofen once last week as well as yesterday and today to see if that would help with inflammation; so far it has not.
Fully vaccinated, not boosted. COVID-19 infection breakthrough with inpatient admit.
VACCINE BUD WAS 04/29/2022 BUT WAS MARKED INCORRECTLY AND GIVEN TO THE PATIENT ON 05/24/2022. THE VACCINE WAS KEPT AT THE CORRECT REFRIGERATED TEMPERATURE THROUGHOUT BUT WAS PAST BUD.
Patient was mistakenly given Fluad adjuvanted vaccine.  Pt had minor local reaction to the vaccine.  No other complication was reported.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 13Jun2023 to 18Jun2023.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for reported events , Drug ineffective and COVID 19, due to a plausible temporal association.
Having Stage 4 cancer and having Alzheimer's, the patient did not leave the house, except for appointments. He had an appointment with the oncologist on 07/22/2021. And on 07/29/2021 he had lab work at Lab Corp.  On 08/02/2021 he was complaining of headaches . The paramedics took him to the ER and he was given an MRI -nothing was abnormal. The ER doctors stated that everything looked good. On 08/04/2021, I called the paramedics again because at 02:00 AM, I heard disturbance and I went into his room and he was disoriented and distressed. The paramedics took him to the ER and he was admitted into the hospital, Hospital on 08/04/2021. On 08/04/2021, he had a fever of 103. On 08/06/2021 he was tested for COVID-19. And on 08/07/2021 I went to the hospital to visit him and they told me no visitors. I called the hospital later that day and they told me he tested positive for COVID-19 on 08/07/2021.   He was released from the hospital on 08/21/2021. I have no choice but to believe he contracted COVID-19 in the hospital because he did not leave the house.
he tested positive for SARS-CoV-2; he tested positive for SARS-CoV-2; This is a literature report for the following literature source(s):  A 64-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mantle cell lymphoma", start date: 2017 (ongoing); "autologous hematopoietic stem cell transplantation", start date: Aug2020 (unspecified if ongoing); "chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rituximab, start date: Dec2020, for mantle cell lymphoma. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset 05Jan2021, outcome "unknown" and all described as "he tested positive for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) 24.60 ug/ml, notes: detectable levels; Viral whole genome sequences: (unspecified date) five of the nine positive; Polymerase chain reaction: (05Jan2021) Positive, notes: for SARS-CoV-2. Therapeutic measures were taken as a result of drug ineffective, covid-19. The following death information was reported, despite no fatal outcome. The patient date of death was 2021. Reported cause of death: "multiple healthcare-associated pneumonias", "pneumothoracies", "bleeding from the ECMOsite". It was not reported if an autopsy was performed.; Sender's Comments: Based on the available information, the reported serious events Drug Ineffective and COVID-19 cannot be excluded for the suspect drug.; Reported Cause(s) of Death: multiple healthcare-associated pneumonias; pneumothoracies; bleeding from the ECMOsite
Client states since he rec'd Hep B on 3/24/14 he has experienced (1) beating in (R) ear and rt side of head and at (R) leg (2) RUE "feels out of place" "sharp pains", difficulty sleeping. Denied experienced prior to receiving Hep B and TYLENOL PRN had provided short relief.
no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
runny nose; coughing; mild diarrhea; This is a spontaneous report from from a contactable consumer (patient).   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, on unknown date as single dose for covid-19 immunisation. Medical history and the concomitant medications were not reported. The patient experienced a runny nose which might be associated with his sinus problem, coughing, and mild diarrhea on unspecified date. The outcome was unknown. The events were assessed as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe pain couldn't touch arm or move. Red, warm to touch,tired, swelling went from top of shoulder down to elbow and had a golf ball shaped swelling by the inside of arm close to elbow. Lasted 3 days. Took ibuprofen and ice.
day 42 without having gotten second dose; food allergies were aggravated; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (day 42 without having gotten second dose) and FOOD ALLERGY (food allergies were aggravated) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (day 42 without having gotten second dose) and FOOD ALLERGY (food allergies were aggravated). On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (day 42 without having gotten second dose) had resolved. At the time of the report, FOOD ALLERGY (food allergies were aggravated) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was reported.
Information has been received from a lawyer, the female patient and spouse of female patient regarding a case in litigation, concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the female patient was administered the ZOSTAVAX by a pharmacist in a pharmacy (lot number, dosage and route of administration not provided). In 2012, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her ZOSTAVAX use: Bell's Palsy. The patient claims damages as a result of injury to themselves, loss of consortium, and economic losses. The outcome of Bell's Palsy was unknown. Upon internal review, Bell's Palsy was determined to be a medically significant event. Additional information has been requested.
Subconjumctival hemmorrhages of Right Eye. EWhite area of eye very red
Employee was measles "non-immune" upon hire. Was given measles vaccine (monovalent) on 12/29/00. He stated on 1/8/01, had blurred vision. That week he developed joint pain. Questioning viral illness. On 3/26/01, follow-up with MD and reports related to vaccine.