chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This healthy 50 year-old received her Pneumovax vaccination on 03 March 2005 at a Clinic where she was undergoing evaluation for chronic sinusitis.  While in the lab 20-30 minutes post vaccination, she began to feel a prickly sensation with itching to her shoulders, chest, face and wrists. She noticed blotching with hives and redness to these areas.  She complained of shortness of breath secondary to feeling a lump in her throat with tightness in her throat and chest. She denied any inability to breath, chest pain, nervousness or syncope. She states these symptoms were similar to reactions she had had in December 2004 with the influenza vaccine and reactions following use of Motrin, NSAIDs, Ultram and Imitrex in 2003.  She returned to Allergy and Immunology and was evaluated.  MD documented generalized erythema of small areas 4mm on the upper shoulders and arms. She began to complain of increasing tightness in her throat and Zyrtec, 0.3cc Epinephrine IM, 60 mg Prednisone PO and 25 mg Benadryl PO were administered.  She complained of palpitations following the epinephrine, but again denied any chest pain or palpitations prior to. She was observed for one hour with resolution of symptoms except for persistent mild pruritic redness to the right cheek and shoulder with complaints of a headache.  She was given 325 mg Tylenol PO for the headache. The HC was called to assist in a case review and VAERS write up.  MD has been evaluating this patient with referral to another MD for chronic sinusitis, constant maxillofacial pain right side with diminished hearing and teeth sensitivity.  She is currently undergoing full laboratory and diagnostic evaluation.
Extreme pain in arm where vaccine was administered. Painful to lift arm. Since I'm pregnant, I can only take TYLENOL and use ice.
Became lightheaded in pm after receiving flu vaccine in am.  Experienced light headedness and dizziness on Wednesday, Thursday, and Friday.  had B/P checked on friday: 116/82 sitting and 110/84 standing.
CLIENT WAS GIVEN 1 YEAR OLD SHOTS ABOUT 10:40AM.  ABOUT 11AM, MOTHER CAME IN WITH CHILD.  CHILD HAD A FINE RED RASH NOTED ON FACE AND BOTH ARMS.  NONE NOTED ON BACK, STOMACH OR LEGS.  CLIENT DID NOT APPEAR TO BE IN ANY RESPIRATORY DISTRESS.  BENADRYL LIQUID WAS GIVEN AND TOLD TO WAIT FOR AWHILE IN WAITING AREA BEFORE LEAVING.  AFTER ABOUT 20 MINUTES OR SO MOM STATED THAT SHE HAD TO LEAVE.  CLIENT STILL DID NOT APPEAR TO BE IN ANY DISTRESS.  RASH STILL NOTED ON FACE AND ARMS BUT NO OTHER PLACE.  TOLD MOM TO GIVE BENADRYL AS DIRECTED AND IF CLIENT DEVELOPED ANY RESPIRATORY PROBLEMS OR RASH SPREAD TO TAKE TO ER AND TO TAKE SHOT RECORD WITH HER.  GAVE MOM OUR PHONE# AND TOLD HER I WOULD CALL TO CHECK AND SEE HOW CLIENT WAS DOING NEXT DAY.  BENADRYL WAS DISPENSED TO CLIENT 4/27/2010.  8:45AM 4/28/10  CALLED TO CHECK ON CLIENT BUT ANSWERING MACHINE CAME ON.  I GUESS IT WAS THE FATHER.  HE STATED HE WAS AT WORK AND TO CALL BACK AT 3:30 WHEN HE GOT HOME.  4:20PM 4/28/10 LEFT MESSAGE.  WILL CALL AGAIN IN MORNING. 10AM 4/29  LEFT MESSAGE FOR 3RD TIME.  10:20  CLIENTS MOTHER CALLED AND SAID HE WAS DOING FINE.  RASH IS RESOLVING BUT NOT COMPLETELY GONE.  NO FEVER OR RESPIRATORY PROBLEMS.  CON'T TO GIVE BENADRYL AS PRESCRIBED.  DR. WAS NOTIFIED ON 4/28/10. RECOMMNEDATION:  RASH WITHOUT ANAPHYLAXIS IN NOT CONTRAINDICTATION TO FURTHER IMMUNIZE.  PREMEDICATION COULD BE CONSIDERED.
headache; chin/head itches; left side face nerve pain; hand tremors; on edge emotionally; something is off neurologically--minor but enough for me to call in sick; This is a spontaneous report received from a contactable consumer (reporting on herself). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EN 6208 and Expiration Date was not re-ported), via an unspecified route of administration in in Arm Left on 24Mar2021 16:15 as single dose for COVID-19 immunization. Medical history included restless legs syndrome from an un-known date and unknown if ongoing. Concomitant medication(s) included carbidopa, levodopa (SINEMET); levothyroxine sodium (LEVOTHYROXIN) both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 on 03Mar2021 15:30 for COVID-19 immunization and patient experience minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea/light headed/dizzy on day 2. On 26Mar2021 at 06:00 patient after second shot of BNT162B2 patient experienced left side of face nerve pain (more than shot one), headache, chin/head itches, hand tremors, on edge emotionally (was fine yesterday), something is off neurologically minor but enough for me to call in sick, hope it is not another shingles outbreak. And saying hopefully in a few days this shall pass. The outcome of the events was unknown.
The patient developed diffuse, erythematous, granular rash on his arm in a 4cm wide pattern radiating from injection site, consisting of very tiny vesicles, closedly packed and grainy to feel. These symptoms began 2 days post vax and lasted 4 days with a low grade fever and fatigue.
Case number PHEH2014US020968 is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to an adult female patient in her thirties. Her past medical history and concomitant medications were not reported. On 14 OCT 2014, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly at a dose of 0.5 ml. On the same day, after the vaccination, she developed a headache, generalized aches, sore muscles and felt unwell like she was coming down with something. The patient had no adverse reactions in the past year. The outcome of the events was not reported. The events were reported as non serious and the causality of the events was not reported.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored of PROQUAD (Merck) Lot# K013867, expiration date 05-MAR-2016; Lot# L004005, expiration date 05-AUG-2016; Lot# L002213, expiration date 21-JUL-2016; (route and anatomical location were not reported). There was no concomitant therapy reported. No adverse effect was reported. This is a linked case with 1505USA014199 from the same reporter. Additional information has been requested.
12/28 sore arm fatigue  for a couple of days.  01/05  nausea, headache, chills, last temp 99.5,  persistent dry  raspy cough
3 days after shots, had joint aches and muscle soreness.  Lasted 2 weeks.  Also, injection site L arm was hot, red and swollen. Went to MD on 6/24/09.  Received prednisone shot, symptoms mostly resolved.  Cleared by Dr. to receive Hep. B. #2 (07/22/09)
Case number PHEH2012US021674 is an initial spontaneous report received from a pharmacist on 24 Oct 2012. This report refers to a 65-years-old male patient. He was vaccinated with MENVEO (batch number: M11073) intramuscularly on 24 Oct 2012. No adverse reaction was reported.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age. The nurse reported that a provider's office (demographics unspecified) reported that unspecified number of doses of (Oka/Merck) VARIVAX (which captured in MARRS# 1404USA008265) and (Oka/Merck) PROQUAD were administered to patients after experiencing varied, and multiple excursions. PROQUAD, (lot# reported as j1131, expiration date: 13-MAR-2015) were exposed to 28F for 403.5 hours, and 295 hours at 4F. Next, (Oka/Merck) PROQUAD, (lot# j013858, expiration date: 01-MAY-2015) were exposed to 28F for 392.5 hours. PROQUAD, (lot# k000712, expiration date: 16-JUL-2015) were exposed to 216 hours 16F. No adverse effects reported. Lot number j1131 is an invalid lot number for PROQUAD (Oka/Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case after 5 vaccines  Moderna 3/9/21 Lot# 030A21A ; Moderna 4/6/21 Lot# 017B21A;  Moderna 10/29/21 Lot# 939906;  Moderna 4/12/22 Lot# 005M21A;  Moderna 9/23/22 Lot# AS7164B
Right eye swollen shut. Event started morning after vaccine and has lasted at least two days. Still ongoing. Symptoms are similar to chalazion
pt recv vax & devel clinical varicella;pt clinical varicella persisted @ the time of the report;
running a little fever; This is a spontaneous report from a contactable female consumer. This 86-Year-old female patient reported for herself.  An 86-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout on 21Jun2021 at 11:00 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported and concomitant medications included warfarin. On 22Jun2021, the patient was running a little fever. It was reported that "yesterday she got her vaccine, the Pfizer, and today she is running a little fever. Caller states she sees that's a little side effect, but they didn't say what to take. The fever is 100, it has decreased she believed a little bit. The patient was just concerned because she took the vaccine and saw that's one of the side effects. She wanted to know should she take Tylenol, it wasn't on the sheet they gave her. She doesn't see where they suggest any kind of medication and also reported that she is also on warfarin a blood thinner and she is allowed to take Tylenol but not ibuprofen. The patient underwent laboratory test included fever resulted 100 F. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Raised welt that grew from a quarter size to a 2" x 3" pink 1/2" size.
REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM); SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM; KNOT THE SIZE OF A ORANGE IN LEFT ARM; KNOT IS HOT TO TOUCH IN LEFT ARM; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM)), PAIN (SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM), MASS (KNOT THE SIZE OF A ORANGE IN LEFT ARM) and FEELING HOT (KNOT IS HOT TO TOUCH IN LEFT ARM) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ERYTHEMA (REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM)), PAIN (SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM), MASS (KNOT THE SIZE OF A ORANGE IN LEFT ARM) and FEELING HOT (KNOT IS HOT TO TOUCH IN LEFT ARM). At the time of the report, ERYTHEMA (REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM)), PAIN (SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM), MASS (KNOT THE SIZE OF A ORANGE IN LEFT ARM) and FEELING HOT (KNOT IS HOT TO TOUCH IN LEFT ARM) outcome was unknown. Not Provided          No treatment information was provided.  No concomitant information was provided.  Action taken with mRNA-123 is not applicable.
patient developed covid symptoms, fever, chills,  muscle aches, runny nose,  sore throat, cough, wheezing, SOB, chest pain, headache, fatigue, diarrhea,  and difficulty breathing. Was hospitalized on 1/13/22 for 2 days
Three hours after vaccines, client experienced headache, upset stomach, diarrhea, and left arm pain lasting for about 3 days. Client missed work 10/24, 10/25, and 10/28/2019
anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (penicillin, aminoglycosides, sulfonamides, ) and drug allergy (dextromethorphan, codeine, morphine).   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Tdap Vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The patient had an anaphylactic reaction to an unknown Tdap vaccine in the past. The reporter did not gave consent to follow-up.
Very bad headache, aches and pains,  very thirsty.  Could not get out of bed. Stared early morning did not get out of bed til 5:30 pm to get something to eat
1/21-22 ARM WAS SORE AND SWOLLEN 1/23 BECAME VERY NAUSEOUS AND HEAD BECAME UNBEARABLY ITCHY 1/29 NOTICABLE BALD SPOTS ON THE CROWN OF MY HEAD AND NOTICABLE HAIR LOSS AND STILL NAUSEOUS 1/29 ALSO HAD A CT LUNG SCAN(SET UP PREVIOUS TO SHOT) AND WAS TOLD THERE WAS AN ISSUE WITH MY KIDNEY(LEFT) SCHEDULED A ULTRA SOUND FOR 2/23 2/18 SECOND SHOT 2/19 VERY NAUSEOUS AND CONTINUED HAIR LOSS(CLUMPS) 2/23 ULTRASOUND DONE AND FOUND THAT LEFT KIDNEY HAD FAILED.
Janssen COVID-19 Vaccine EUA On 4/13/2021, I work up and noticed a rash on both of my hands and wrists consisting of little small red docs about the size of a pencil eraser.  That night, my knees where very itchy and I noticed the rash was on my knees, thighs and hips.  On 4/14/2021, I woke up and the rash was all over my body from the neck down.  My left arm was very red with my right arm not having as much redness.  My knees very extremely red with little normal skin color showing.  The rash was slightly itchy.
Anaphylaxis. Used epiPen, taken to ER. Given solumedrol 125 mg, bendadryl, 25 mg IV monitored 4hours. Sent home with solumedrol dose packet and new epipen
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Starting day after first dose: severe nausea, vomiting (three times), joint pain, malaise starting day of third dose: chills with muscle spasm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 69 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ESTRADIOL VALERATE; PROGESTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (24Jun2022) Positive, notes: Recurrence of Covid symptoms 8 days after completion of Paxlovid treatment, including positive self-test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid treatment from 12Jun2022 to 16Jun2022 for Covid-19. other medication with two weeks of vaccination was Estradiol Valerate and Progesterone.  No follow-up attempts possible. No further information expected.
C/o abdo cramping 2 hrs post vax. Examined at UCLA. Dx with vaccine related abdo cramps and nonvaccine related viral gastroenteritis.
Within 15-minutes of vaccination, the patient reported feeling short of breath and lightheaded. Patient stated this was a regular occurrence and that it happens multiple times a week. Patient also attributed it to her anxiety. Patient was hypertensive (180/88), A&Ox4 with GCS15. Patient sat down to catch her breath and stated improvement. Patient refused transport.
Eyes started itching about 12 minutes after injection. Started getting very dry mouth  and throat 15  minutes after shot. Felt lump in throat and throat tight about 17 minutes  afterwards
Nurse inadvertently administered frozen Havrix, flulaval to patient.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient was administered with frozen vaccine Havrix and FluLaval Quadrivalent season 2020- 2021, which was kept on temperature ranging from negative 8.2 to negative 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same nurse.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100521:same reporter
26 hours after the vaccine he developed angioedema of the lips. I started him on oral prednisone. He denies any other medication changes, travel, exposures, etc.
Slight fever (99.0 D) at night of shot. Chills, muscle ache, fatigue, headache.
This spontaneous report as received from a nurse refers to an unknown number of patients. On an unknown date the patient was vaccinated with GARDASIL (lot# was not reported). The nurse reported that the patients might have received improperly stored GARDASIL. No adverse event reported. Additional information is not expected.
C/o left upper arm pain with redness and warmth. Pt received PNEUMOVAX 23 vaccine 8/17/16. Pt states symptoms started shortly afterwards. He states symptoms have improved over last 24 hours. He denies respiratory distress, chest pain, and all other constitutional symptoms.
After the second dose, spotting was continual but light and not overly worrisome; After a couple a couple months of this spotting I had a period of about eight hours with large clots and very heavy bleeding.; probably hormones; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant (including at the time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the public health clinic/veterans administration facility.  Medical history included amenorrhoea. Concomitant medications were not reported.  The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE  on 08Apr2021 01:45 PM (lot # ER8730) at the age of 33-year-old as 0.3 mL for COVID-19 immunization. She had menstrual spotting  after first dose that repeatedly came and went in 2021. Then, had the 2nd dose in 2021. After the second dose, spotting was continual but light and not overly worrisome. After a couple of months of this spotting, she had a period of about eight hours with large clots and very heavy bleeding. After this episode clots became more persistent and went to have doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. They said it was probably hormones and put the patient on birth control to make it stop. However, she now have hives due to the birth control pills which she have stopped taking and back to daily bleeding and clotting. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. The events were considered as serious (disabling) and not yet recovered from the events.  Information about lot/batch number has been requested.
This case was reported by a consumer and described the occurrence of queasy in a female patient who received FLUARIX. Co-suspect products included ADVAIR Diskus inhalation powder for chronic obstructive pulmonary disease. On an unknown date, the patient received FLUARIX at an unknown dose. In August 2002, the patient started ADVAIR Diskus at an unknown dose and frequency. On an unknown date, an unknown time after receiving FLUARIX and ADVAIR Diskus, the patient experienced queasy. On an unknown date, the outcome of the queasy was unknown. It was unknown if the reporter considered the queasy to be related to FLUARIX and ADVAIR Diskus. Additional information received: The patient said she had a lung infection and then said no she just felt a little queasy from the flu shot, which she got a few days ago. She stated she is fine, and did not want to answer any other questions.