chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse regarding an unspecified number of patients of unspecified age and gender with no pertinent medical history reported. The reporter stated that GARDASIL, RECOMBIVAX HB and VAQTA that underwent an unsupported temperature excursion were administered to an unspecified number of patients on unspecified dates (lot numbers and expiration dates not reported) (dose, frequency, and route were not reported). No patient contact details were available. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUD (lot# M011661, expiration date: 18-SEP-2017) (dose, route of administration and frequency were unspecified), which were exposed to a temperature of 8.8 Fahrenheit degrees for a time frame of 40 minutes due to a digital data logger, then the vaccines were put back in range. No adverse effects were reported. This is one of several reports from the same reporter (linked case: 1608USA008915). Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative refers to a 72 year old male patient (husband). Approximately on an unknown date in March 2011 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date in December 2012, the patient experienced shingles rash on his right flank along with post-herpetic neuralgia. The symptoms resolved with treatments of ZOVIRAX ointment and VALTREX. The outcome of the events shingles rash on his right flank and post-herpetic neuralgia was reported as recovered/resolved. Causality was not reported. Additional information has been requested.
Anxiety Body aches Heart palpitations  Shivers Fever Fatigue Joint pain Muscle pain
COVID-19 positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: covid-19 positive (Positive) COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
I am a pharmacist and I receive a season flu vaccine at the Pharmacy on Oct. 1, 2019 by one of my colleagues.  I had some soreness, at the site and thought it would go away after a few days, but on Saturday Oct. 5 I continued to have soreness, some weakness and it became painful to take off and put on t-shirts. I massaged the area and realized there was tenderness in my shoulder joint area.  It was then I realized the vaccine needle must have been inserted too high.  I have been able to effectively self treat the pain by taking some otc naproxen sodium 220mg twice daily and limiting my movement to avoid pain.
Hospitalization: 9/23/2022 - 9/27/2022.  Presentation to the ED: AMS, COUGH, NAUSEA, VOMITING, DIARRHEA.  COVID-19 + date: 9/23/22. Treatment: NO TREATMENT GIVEN SPECIFICALLY FOR COVID INFECTION. Discharge to: Home or Self Care.
Overall systemic aches, pain in back of neck near spine, rn injected through vessel causing bleeding. Arm 24 hours post is swollen at injection site and very sore under arm. Left arm is weak
Initial report was received from a consumer, who was also the patient, on 04 October 2012. A 66-year-old female patient received an intramuscular injection dose of FLUZONE HIGH-DOSE, sanofi pasteur Inc., (lot number not reported) on 25 September 2012. On the same day, 25 September 2012, the patient developed chest pains, shortness of breath, throat swelling, difficulty swallowing and hypotension with blood pressure (BP) 84/50. The patient was taken to the emergency department (ED) and treated with Prednisone and BENADRYL. The patient claims she went into shock and was hospitalized for two days and released from the hospital. The patient stated her electrocardiogram "(EKG) was ok", on date not specified. The patient denied allergies and claimed to be in good health. She denied any illness at time of vaccination and denied any other vaccinations within prior four weeks of vaccination. The patient's outcome was reported as recovered on unspecified date. (and also reported as unknown). Documents held by sender: None.
Muscle ache at injection site, fever, chills. Similar side effects for both first and second in series of immunizations.
Following vaccine administration, patient experienced episode of syncope without loss of consciousness; patient monitored in clinic 20 min following episode until able to ambulate and drink water without difficulty. Vital signs checked to ensure stability, remained stable throughout event.
Fever and chills for about 12 hours starting 9 pm on the day of the vaccination (Tuesday 4/9/2019). Edema of the left arm pit (vaccination arm) starting Thursday morning (4/11/2019) and lasting for 3 days.
Immediately felt tingling at left side of base of the skull, which then traveled down left side of upper body. Within hours developed tingling/numbness in left side of face (especially jaw) left arm and left leg, and stiffness in left side of mid-back. All symptoms began to improve the next day, except the facial numbness, which peaked around day three. Facial numbness improved very gradually over the course of weeks, but some minor facial numbness persists. Pain in left arm (especially wrist) and left leg (especially foot) returns occasionally.
Client has skin discoloration and one sided lump under skin on left deltoid since receiving Td vaccine. 5/24/04 client denies pain.
No adverse event; I believe a single dose of Moderna bivalent vaccine was administered after expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I believe a single dose of Moderna bivalent vaccine was administered after expiration date.) and NO ADVERSE EVENT (No adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (I believe a single dose of Moderna bivalent vaccine was administered after expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I believe a single dose of Moderna bivalent vaccine was administered after expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (I believe a single dose of Moderna bivalent vaccine was administered after expiration date.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
No side effects reported.; HCP calling to report GARDASIL 9 was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided.         ?    Names of vaccines involved (including lot/exp): GARD; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUL-2023, HCP called to report GARDASIL 9 was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided. Expiration occured for 1 hour 40 minutes in 50 F. Additional AEs filed, refer to cases 02437481, 02437482, 02437484, 02437485, 02437486, 02437488, and 02437489. No PQC.
Patient noticed a rash on the upper abdomen, both arm pits, and down the spine. A little itchy. (morning of 01/09/2021) Rash is red and not raised.
Leading up to my adverse event, I had been feeling more and more tired. I did not have any problems breathing, I just felt tired. I ability to walk had decreased. I noticed it had been going on for some time. I noticed it, but I didn't get concerned because it could have been related to the muscles from my eye condition. I started to feel a decrease in energy all around. The day, 05/30/2021, my husband was not home. I was home alone. I had a zoom call, with some of my friends, and as we were hanging up on the call, I started to feel as if I were going to faint. I did not have any other symptoms besides fainting. My mind felt clear. I had my cell phone next to me, and I texted my friends and told them how I was feeling. I ran to my bathroom because I had to use the restroom. I sat there and felt like I was fighting fainting. My friends called me and I was having problems speaking. I told them I was fainting and I needed their help. They called an ambulance for me, but they are out of state, so there were problems. I contacted someone closer to me to make a call for an ambulance. I was only able to text by dictation, I couldn't type anything. My friend who I called, came over to my house right away. I had to get myself out of the restroom and make it to my front door to let her in. It was difficult. She called 9-1-1 when she got to my house. The paramedics gave me a baby aspirin right away. I felt that I could talk better after taking it. They gave me nitroglycerin as well. They put me in the ambulance and I stayed awake and alert the whole ride. They took me to The Hospital and took me right in for surgery. I was experiencing a heart attack. I had a couple of stints put in and they did it through the groin area. I was alert through this surgery. I felt sensations, but I did not feel any pain. I am now taking a baby aspirin, carvedilol (coreg) 3.125 mg (2 in the AM, 1 at PM), Plavix 5mg (1 per day) and Rosuvastatin 20mg (1 per day). Since I have had the surgery, I noticed that I have had some blood in my urine. I am following up with a Urologist to see what is going on. She wants to put a scope up my urethra to see if she can find anything.  As of today, I feel so much better than I did. I can walk better and move more quickly now. I'm very thankful for the doctors at the hospital and how they handled me.
I contracted COVID from my 2 year old son after long term exposure caring from him. My symptoms are very minimal and mild. I tested negative for 4 days but on day 5 of caring for him I contracted it.; I contracted COVID from my 2 year old son after long term exposure caring from him. My symptoms are very minimal and mild. I tested negative for 4 days but on day 5 of caring for him I contracted it.; pregnant at the time of the vaccination; This is a spontaneous report from a contactable other healthcare professional (hcp). A 34 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 12Feb2021 (Lot Number: EL9266, expiry date not reported) as first dose single (at the age of 33 years old); then via an unspecified route of administration, administered in right arm on Feb2021 (Lot Number: EN6199, expiry date not reported) as second dose, single; for covid-19 immunisation. Medical history included hypothyroid, PCOS and known allergies to bananas. The patient had no covid prior vaccination. Concomitant medications included levothyroxine and metoclopramide (REGLAN), both taken for an unspecified indication. The patient had no other vaccine in four weeks. Patient was pregnant at the time of the vaccination and event at 15 weeks gestation, with last menstrual date as 30Oct2020 and delivery date on 13Aug2021. Patient had contracted COVID from her 2 year old son after long term exposure caring from him. Her symptoms were very minimal and mild. On 02May2021, he was tested negative for 4 days but on day 5 (05May2021) of caring for him she contracted it (positive). No treatment received in response to the events reported. The outcome of the event contracted COVID from her 2 year old son after long term exposure caring from him was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and Vaccination failure.  There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.
numbness in lower legs, dizziness, nausea, tired, chills, hot flashes. couldnt sleep that night, really felt like i had the flu and a headcold at the same time
The pt experienced fever of 106.3. The fever started the evening of the vaccines. Children's Motrin was given and the temp decreased to 104. The baby was taken to the ER.
nausea and diarrhea, rash at injection site, rash under the skin, blotches on face
Inflamed left lymph node; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure, and pituitary adenoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim (SEPTRA) and experienced drug allergy. On 01Apr2021, the patient experienced inflamed left lymph node and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events inflamed left lymph node and arm pain was resolved on an unknown date in Apr2021. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Injection site soreness and pain shooting down the injected arm, starting the day of injection and continuing for 3-4 weeks following the injection. The day following the injection I started breaking out with an itchy eczema type rash around my lips that progressed to the point that my lips were red, swollen and cracking at the corners. The rash worsened over the first week after the injection then slowly improved. It was a full 4 weeks before the rash began to heal and stop hurting badly. I also had the usual fatigue and body ache so that come with getting the vaccine but the lasted 2-3 weeks, which is longer than usual for me.
12/25/22 presents to ED for "nausea, vomiting, diarrhea". PMHx of "DM Insulin dependant, CKD, HTN, HLD, sarcoidosis"
Significant pain in R hip approx. 4-5 hours after vaccine. Lasted until next morning.
After about a month of my 3rd dose I started noticed I had hand tremors, my body was anxious, my head was bobbing-like. That is when I first noticed it had gotten so bad. Some days it is worse than others. I cannot control the shakes in my hands. I went to Dr. last week -I had to cancel my December 15th appointment because my doctor was out. I follow-up with Dr. January 13th  He actually increased my Xanax. He asked if me if I wanted to see a Neurologists.  I wanted to wait and see and give it some more time but now feeling like I want to see a Neurologist.  I am also having painful jaw like lock-jaw as long as I am using my night guard and chewing gum, I am fine but if not the pain starts back. It is worse at times than others too. I have seen a dentist for a new mouth guard.   The week after the holidays I felt bad and had Covid and Flu test. I felt like I had the flu. Dizziness, stomach and body aches.  My husband went the next day and tested positive for Flu.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender unspecified). On an unknown date the patient was vaccinated with ZOSTAVAX. Dose and route were unspecified. Pharmacist mentioned that the patient received ZOSTAVAX and then got shingles. The outcome of shingles was unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to a unspecified patient of unknown age and gender. On 21-AUG-2014 the patient received a dose of improperly stored PROQUAD (Merck) (lot# not reported, dose 0.5 ml, subcutaneously), exposed to 38F for 24 hours. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 22-MAY-2014, patients were vaccinated with LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided) lot # J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338, 1405USA013916, 1405USA013915, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA4901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Patient began to look pale and feel unwell after vaccination. He was breathing deeply. He never lost consciousness or fell.  Patient was given water and when patient stated he had not eaten, patient was given crackers. Patient stated he had trouble swallowing the cracker. Patient sat on ground and still felt unwell. EMS was immediately called. Patient lay on the floor when EMS arrived. Patient stated he never had a previous reaction like this to a vaccine. EMS checked out patient.  Patient walked out of pharmacy unaided
PATIENT FELT DIZZY 5 MINS AFTER GETTING THE VACCINE HE STATED IT TYPICALLY HAPPENS TO HIM EVERY TIME HE GETS A VACCINE
TEMP EXCURSION- ROOM TEMP (68*) FOR >12 HOURS. PT REPORTS NO SIDE EFFECTS
sick for about 3 days; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 (Lot number: ER8731) at the age of 49 years as dose 2, 0.3ml single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: diagnosed 8 or 9 years ago; "chronic pain" (ongoing), notes: she has chronic pain. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EP7534, NDC: Unknown, Expiry Date: Unknown, Dosage text: Injection, right arm, 0.3 ML, She felt like she had the flu), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 Immunization, reaction(s): "She felt like she had the flu". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick for about 3 days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient takes a number of medications, she has chronic pain, she has fibromyalgia that they are treating,she went to the doctor and they of course gave her a Covid test which was negative, they just said she would have to ride it out, in Mar2021. She has had Covid tests ongoing on and off throughout the pandemic and they all have  been negative.   No follow-up attempts are possible. No further information is expected.
Clinician ordered for patient to be given DTaP, MMR, Varicella and PREVNAR 13. Patient was given Act Hib, MMR, Varicella and PREVNAR 13. Family notified to come back for DTaP.
Pharmacist double-checked date of birth but overlooked the child is >12 years old. Gave the orange top vaccine in error. Pharmacist noted in her file to receive the purple top dose the next time.
This spontaneous prospective pregnancy report as received from a Nurse Practitioner for VARIVAX (Merck), a Pregnancy Registry product, refers to a 15 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with VARIVAX (Merck) (lot # not reported) on 17-AUG-2012. It was reported that the patient may be pregnancy. The Nurse Practitioner did not know the date  of the patient's first dose of VARIVAX (Merck). The Nurse Practitioner provided a urine pregnancy test for the patient which was positive for pregnancy. The test was repeated and was found to be positive for pregnancy. No adverse experience has been reported or observed. No other co-suspects were reported. There were no concomitant medications were reported. The patient with an LMP of July 2012 ("late July") and EED of approximately 07-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought unspecified medical attention. Follow up information has been received on 11-NOV-2014. A phone call was placed to the reporting nurse who was no longer at facility. The facility was unable to share the patient information without a signed consent form. Reporter information has been updated. Additional information is not expected.