chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered to the patient.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient.) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not  provided.  Nurse have 5 patients that were vaccinated with Moderna Covid-19 vaccine that expired on 11AUG2021.  The vaccine had been placed in the refrigerator from the Freezer on 12JUL2021. There were a total of 5 ten dose vials. that had expired past the beyond use date of 11AUG2021 in the refrigerator.  The vaccine under went no temperature excursions. The vials were taken from the refrigerator for administration and exposed to room temperature fro 5 minutes. One dose was given 24AUG2021, second expired dose given 26AUG2021, and the last 3 doses were given on 27AUG2021. The remaining doses of the Moderna Covid-19 vaccine that were not given were wasted and disposed of today 30AUG2021.
Dizziness, tingling/numbness of bilateral hands, pale. Vitals wnl. Water given.
Nasal congestion; Runny nose; COVID; Headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Nasal congestion), RHINORRHOEA (Runny nose), COVID-19 (COVID), HEADACHE (Headache) and MYALGIA (Myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medication were reported by the reporter. Hot water bath improved his symptoms.   This case was linked to MOD-2021-255442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up TCR received and event added COVID-19 from previous version
March 4, went very well.  I received my first PCV13 vaccine at that appointment.  The nurse did a wonderful job of administering the vaccine-it did not hurt!  Unfortunately, starting that evening I did start experiencing all the classic side effects of a reaction-sore arm, body aches, low grade temperature....general yuk.  All those symptoms continued thru Saturday.   Also, starting on Thursday, my arm became very sore, red, swollen and very warm to the touch.  Took Tylenol and applied ice pack occasionally.  The redness, swelling and itching seemed to grow and be traveling down my arm towards my elbow and to the underside of my arm.   Starting Sunday my temperature returned to normal and the redness and swelling has lightened but I can still feel the itchy feeling in my arm.  It is definitely getting better.
Severe nausea & dizziness the night after the vaccine was administered and throughout the following day. Subsided within 72 hrs.
Headache, body aches and pains for two days.  Fever(99.9) 2nd day
sore throat, but different; white bumps in her throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat, but different) and SENSATION OF FOREIGN BODY (white bumps in her throat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 081A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Diabetes mellitus.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat, but different) and SENSATION OF FOREIGN BODY (white bumps in her throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat, but different) and SENSATION OF FOREIGN BODY (white bumps in her throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pharyngitis streptococcal: negative Negative. On an unknown date, SARS-CoV-1 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
NauseaVomiting, Palpitations, see net section Narrative: Prior to vaccine, emp consulted with PCP, who recommended PO Benadryl prior to vaccine, due to prior vac rxn; employee took benadryl prior to vaccine. Dose#1, Day #2 BILAT shoulder pain, didn't feel like self, nausea/voiting with skaking chills, trouble breather; coworker got stretcher, gave O2, took to ED, received IV with solumedrol, benadryl, decadron, po ativan and zofran; discharged home, slept, woke up on Day#3, systemic symptoms resolved, local LEFT arm site pain. experienced heart rate increasing and then normal, after returned home, still experiencing this, not daily.
Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and headache. Patient denied difficulty breathing or swallowing. Denied chest pain or palpitations. Patient reports dizziness began 3 weeks ago. Glucose was 167.
Within 12 - 18 hours developed 102.9 fever, extreme fatigue and headache (Day 1).  Fever slowly reduced to normal over next 4 days. Day 2 fever 101.8 fatigue and headache.  Day 3 fever 100.2 fatigue and mild headache.  Day 4 Normal temp - fatigue continued thru day 7 and still present.   Treatment:  Tylenol and complete bed rest days 1 thru 4.
Severe weakness, collapse to floor, unable to get up. Incontinence.Headache, fever, sweating, chills. Mental confusion. Some taste changes.
Site pain for both doses for less than 48 hours.; Tinnitus beginning 2 days after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 08:30 (Lot number: Ew0167) as dose 2, single for covid-19 immunisation; multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) (Batch/Lot number: unknown). Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "chronic UTI" (unspecified if ongoing); "Lumbar Radiculopathy" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: Bnt162b2 (Dose number=1, lot number=Ew0158,, administration time=08:30 AM,, vaccine location=Left arm), administration date: 11Apr2021, when the patient was 49 years old, for Covid-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "Site pain for both doses for less than 48 hours."; TINNITUS (non-serious) with onset 04May2021, outcome "not recovered", described as "Tinnitus beginning 2 days after second dose". Therapeutic measures were not taken as a result of vaccination site pain, tinnitus.  Additional information: Other medications in two weeks: other daily prescriptions. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination nor tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient is a very pleasant 66 YO man who was admitted to hospital for acute respiratory failure 2/2 COVID.  Was vaccinated J+J vaccine- no booster.  While admitted was given Remdesivir and treated with steroids.  Was also given antibody infusion.  He was weaned down from 2L to no oxygen requirement prior to discharge.
The day after receiving the vaccine, Saturday, February 27, 2021. I woke up with a sever headache that felt like tension or a wire across the middle of my forehead.  I took Tylenol Extra Strength Rapid Release gels.  About 2 hours after I woke up, I threw up once.  I stayed in bed the rest of the day, drinking mainly water.  I did not eat breakfast.  Around 2:30 - 3 pm I felt well enough to eat so I had a little bit of soup and crackers. Watching TV made the headache worsen so I went back to bed.  Took a shower and went to CVS around 4 just to get some fresh air and get some TUMS as I was also having heartburn. Finally went to sleep.   Sunday morning I woke up with very faint headache, but I felt off. Like I had a fast pulse, but I didn't. I checked my blood pressure around 9:30 am and it was 147/82m pulse at 85.  I drank water, went out driving to get some air.  Felt better and when I checked my blood pressure and pulse at 11:15 am it was 104/74 with pulse of 79.  Monday and Tuesday, slight headaches and a bit of morning nausea.
Soreness in left jaw with popping while chewing or opening/closing mouth.  Same side as TDaP vaccine given 12/15/10 on left arm. Got progressively worse 12/16/10-12/17/10 and improved 12/18/10-12/19/10.  Limited ability to eat solid food 12/16/10 and 12/17/10. No treatment sought.
suspected vaccination failure; shingles outbreak; itching; rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and rash. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received his 2nd Shingrix dose about 3 months prior to this report. The patient experienced itching and what he believed to be a mild case of Shingles along the axillary area and along his trunk. The patient had a rash that was about 1 cm in diameter. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation were unknown at the time of reporting.
MOTHER BROUGHT CHILD INTO OFFICE O9/12/03 TO HAVE IZ. SITE ASSESSED. IZ.GIVEN IM. ON LD. CHILD C/O HEADACHE,ANOREXIA, ARM RED, VERY SWOLLEN AND HOT.  tHIS WAS 4TH DOSE OF DTaP. MOM GAVE CHILD TYLENOL & STATED ARM IS LOOKING MUCH LESS SWOLLEN AND CHILD FEELING BETTER,JUST WANTED TO BE SURE IT IS OKAY.
Entire upper arm very sore, fever, nausea, muscle aches,frequent bowel movements, overall ill feeling lasting approximately 36 hours.
Ear ache; Fluid in the ear; Vaccine administered at inappropriate site (Left leg); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 31Mar2021 10:30 (Lot number: ER8734) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: Left leg; Administration time: 13:30.), administration date: 03Mar2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "vaccine location: Left leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31Mar2021 10:30, outcome "unknown", described as "Vaccine administered at inappropriate site (Left leg)"; EAR PAIN (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Ear ache"; MIDDLE EAR EFFUSION (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Fluid in the ear". The events "ear ache" and "fluid in the ear" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of ear pain. Therapeutic measures were taken as a result of middle ear effusion.  Additional information: 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 did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food, or other products. Patient experienced ear ache, fluid in the ear and drainage on the left side of head. Two weeks and still not cleared up. Therapeutic measures were taken for the event fluid in the ear and included drainage on the left side of the head. The patient reported that treatment included decongestant but was not taken.  No follow-up attempts are possible. No further information is expected.
Herpes zoster diagnosis in herpes zoster vaccine recipient. Diagnosed by Dr. at Health Center. Acyclovir x 7 days. Duration was less than 4 weeks. Also visited an ophthalmologist. Unilateral, 1 dermatome.
Tingling and numbness in arms from elbows down through fingers and toes on right foot. Lasted for 2 weeks
Information has been received from a physician, concerning a 16 year old female patient, who on 12-FEB-2007 was vaccinated with the first dose of Gardasil, and reported no symptoms or concerns. On 09-APR-2007, the patient was vaccinated with the second dose, 0.5ml, IM, of Gardasil (Lot #657617/0384U). Concomitant therapy included Augmentin. On 12-APR-2007, three days after the second vaccination was administered, the patient experienced urticaria all over her body, especially on her extremities and face. Treatment included Benadryl. At the time of this report, the physician confirmed the patient was recovering from the urticaria. Additional information has been requested.
This patient received the DTAP vaccination the day of discharge from the postpartum unit at the clinic on 23 Aug '12. She reports the injection was given high near the right shoulder. She reports that the next day her right arm was sore and 'hurt to move it in any direction'. She denied flu -like or other associated symptoms. 3-4 days after vaccination the pain worsened which necessitated using the left arm for most activities. Systemic symptoms: Currently the pain is constant and severe, partially controlled by ibuprofen 800mg tid which she had been taking for 2 weeks. She states she is unable to lift the arm above the shoulder, is tender to palpation and feels weak. The pain awakens her out of sleep, and she is unable to put pressure on the arm to push self up. Sometimes the pain shoots down the arm to the fingertips and there is pain when she moves the right wrist. She reports there is no visible swelling or redness, no axillary tenderness, no chest wall pain. Diagnosed with adhesive capsulitis by orthopedics. No steroid injection given due to breastfeeding newborn. Undergoing Physical Therapy.
Patient flushed, shivering and slow to respond to questions. Patient had decreased strength in upper extremities. Upon exam patient's symptoms suggestive of stoke. Patient transferred to ER where a CT was dine which showed intracranial hemorrhage.
pt recv vax & approx 10hr p/vax pt exp a rash @ the site of inj, itching, red welts on lt upper arm;upon exam 6AUG97 pt had an approx 1.5cm area of induration & erythema w/local heat around the puncture wound @ inj site;
Allergic reaction; no energy; no appetite; he is not feeling good at all; has been in bed all day; fever; splitting headache; Pfizer COVID-19 vaccine made him sick as hell; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot: Number: EN5318, Expiration Date: May2021, NDC: Unknown) via an unspecified route of administration from 04Feb2021 14:24 at single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Historical vaccine included unspecified flu vaccine 2-3 months ago and patient received made him sick as hell, zero energy and losing weight. The reporter stated that Pfizer COVID-19 vaccine made him sick as hell: Consumer says he got his first dose of the COVID-19 vaccine yesterday at 02:24 PM and had an allergic reaction to it, he is not feeling good at all and he has never been allergic to anything before. COVID-19 vaccine NDC: Unknown, this was not provided on his handwritten vaccine card. Caller says he also had the flu vaccine 2-3 months ago and the flu vaccine also made him sick as hell, the same thing happened. unspecified flu vaccine NDC/LOT/EXP: Unknown. Caller says that his allergic reaction is that he has no energy and no appetite. He says after the flu vaccine he had zero energy and ended up losing weight. He says he has felt like this again since getting COVID-19 vaccine yesterday and has been in bed all day. He says he had a fever this morning and a splitting headache. He says his fever temperature was unknown, he had done no treatment for that, he laid in bed all day, and he has done no treatment for the headache either, though he is thinking about taking some Tylenol in a minute. He says he wants to get better and he might need to call his doctor for information about what to do to get better, he just wanted to see if Pfizer could provide any solutions for him. The clinical outcome of the events was reported as unknown.
Patient fainted about 3 minutes after receiving her 3rd dose of Gardasil. She did not lose consciousness. She had not eaten at all that day. Was given juice. VS were stable.
within 2 min of sitting for observation period, pt reports heart was "fluttering".  Lasted about 2 min.  Notified staff.  BP was taken.  150/90.  Fluttering had already resolved at that time. FYI-pt states she completed her Z-pack on 1/26/21-sinus infection. PCP aware of above; recommends 2nd dose be given  in hospital setting.
Mild headache over the next couple of hours; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 11:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included mepyramine maleate, pamabrom, paracetamol (PAMPRIN) and ibuprofen (ADVIL); both from unknown dates for unspecified indications. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, the patient experienced mild headache over the next couple of hours. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event mild headache over the next couple of hours was recovered on 03Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
12:00 AM - fever started Day following vaccine,  fever (100.0) & heartrate jumping between 94-200 Within an hour, it settled at 119 and stayed around 119 for a few hours By that evening, it was down to 74 and went up to 130 with any activity (for example, walking slowly up the stairs) She also had a sore throat, runny nose, headache and cough on this day and presently.   (she tested negative for Covid) Her fever& fatigue lasted off and on for 2 days. As of 8/22, she is still has a cough, sore throat and headache - no fever,   Her pulse only jumps up to 120-135 a few times a day.   She feels dizzy, weak and her head feels "heavy."
Information has been received from a 60 year old female registered nurse, with no pertinent medical history and no known drug reactions or allergies, who on 07-JUN-2010, was vaccinated subcutaneously with a "single dose" of ZOSTAVAX (Merck) (Lot number 663333/1555X) (Expiration date 28-APR-2010). There was no concomitant medication. On 07-JUN-2010, the patient experienced soreness at the injection site, black and blue area at the injection site and swollen area at the injection site. The patient did not seek medical attention. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. Follow up information has been received from a physician. It was reported that in the morning of 07-JUN-2010 the 60 year old (also reported as 59 year old) nurse was vaccinated in the right deltoid with a first dose of ZOSTAVAX (Merck) (Lot number 663893/0128Y) (previously reported as lot number 663333/1555X). There was no illness at the time of vaccination. The physician reported that the patient's right deltoid got black and blue. On 20-JUN-2010 the patient recovered from right deltoid black and blue. No further information is expected.
5 days after vaccine administration, patient suffered a full 24 hours of violent vomiting and diarrhea. No other illnesses suffered in household. After 24 hours, N/V resolved, however patient reported having white stools after this event.
It started around March. I felt like my toes were sore. They were sensitive, if I wore shoes for a long length of time they felt weird. I thought they were blisters but I didn't see anything. It was the very tips of my toes. A few weeks went by and the tops were now red and sometimes purple. At night they would bother me and they were painful. I felt is anything touched them they were very painful. I went to an urgent care and the person diagnosed me with Athlete's foot without much information. She gave me an over the counter medication for 21 days and my feet got worse. I went back to the same urgent care and saw a different doctor and I was referred to a podiatrist and she didn't think it was athletes. It took a while to see the podiatrist and he diagnosed me with Raynaud's disease. He has given two other medications and I am to return in two weeks to see if his diagnosis is correct.