chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient did not report any allergic reaction to any vaccine or medications when asked during consultation prior to administration. The pharmacist had administered the vaccine and patient was sent to the waiting area to wait the mandatory 15-20 minutes after receiving the shot. Patient was seated and after 5 minutes, patient disclosed with another patient in the waiting area that she was not feeling well. After a few min she lost consciousness for less than a minute, her eyes rolled back. Epinephrine was not administered. When she became conscious, she refused medical treatment. Patient was nauseous and vomited a few times.  A pharmacist checked vitals and all were within normal limits and a neuro check was also performed which was normal. Patient was given water, gingerale, raw ginger, and ginger tablets for the nausea. Patient was also given saltine crackers. Patient's aunt arrived at the scene. Patient reported feeling chills and weakness. Patient did not feel comfortable standing/leaving. Pharmacist stayed with the patient for 90 min until patient was stable and walked the patient to the aunts car. At the end of the event patient reported having vasovagal syncope and has a history of fainting at the site of blood, too much stress, and anxiety, but never after vaccines.She reported she did not eat anything in the morning and just drank coffee.
Moderna COVID-19 Vaccine EUA  Emesis starting the morning after receiving the vaccine.  Self limited (about 3-4 episodes in total).  Some aches and chills - also self limited.  Was not sure this even needed to be reported but was encouraged to do so.  Am OK now (post vaccine day 2).  thx.
pt started having a productive cough and worsening SOB on 12/25/21; took a home COVID test and it was positive; 1/1/22 to hospital with worsening SOB, O2 sats in 80s on RA; admitted; positive COVID test; respiratory status worsened; intubated; a few days later he was able to be extubated with high flow NC to 65% 60L; became hypoglycemic; UTI; given ABX; O2 requirements increased, on blended HFNC with NRB support; transferred to ICU and required intubation again; right pneumothorax; chest tube placed; tracheostomy done; 2/2/22 COVID test still positive; pulmonary status worsened with hypoxia; DNR; pt passed away in the hospital
Caller stated that vaccine leaked while injecting the patient with pre-filled 0.5mL syringe/No AE; Patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe; Initial information regarding an unsolicited valid non-serious case received from a consumer and transmitted to Sanofi on 25-Oct-2019.  This case involves an unknown age adult patient who experienced caller stated that vaccine leaked while injecting the patient with pre-filled 0.5ml syringe/no ae (syringe issue) and patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe (underdose), while received vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a single dose of suspect influenza quadrival a-b vaccine lot UJ212AB expiration date: 30-Jun-2020 via unknown route in the arm nos for prophylactic vaccination.  On an unknown date, it was reported that vaccine leaked while injecting the patient with pre-filled 0.5ml syringe/no ae (syringe issue) and patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe (underdose).  It was not reported if the patient received a corrective treatment.  Event outcome was not applicable for both events.
Patient received ZOSTAVAX 11-14-11. When she went to work 11/15/11 and sat down by her press (360 degrees) she developed flushing, lightheadedness and hives around her neck. By the time she arrived home, hives were fading. Advised TYLENOL & BENADRYL.
It was reported that a 2 month old male received a Tripedia, Hep-B, Hib and a Polio vaccination. Reportedly, sometime after the vaccinations, the pt developed a fever of 103F. Unable to determine source of fever, the pt was hospitalized for fever management. Further information requested.
LOW ANTIBODY TEST; ARM HURT FOR A COUPLE DAYS; ITCHY EAR(ONLY ONE); A LITTLE NASAL CONGESTION; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to soybean oil, and autoimmune, and other pre-existing medical conditions included: The patient did not have thyroid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced itchy ear (only one). On 06-MAR-2021, the patient experienced a little nasal congestion. On 06-MAR-2021, the patient experienced arm hurt for a couple days. Treatment medications included: guaifenesin/pseudoephedrine hydrochloride. On AUG-2021, the patient experienced low antibody test. Laboratory data included: COVID-19 antibody test (NR: not provided) Protein negative, proteins quantitative 151. The action taken with covid-19 vaccine  was not applicable. The patient recovered from itchy ear (only one), and a little nasal congestion on 06-MAR-2021, and arm hurt for a couple days on 08-MAR-2021, and the outcome of low antibody test was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000206625.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
her eyes had a hard time focusing and feel fatigue; her eyes had a hard time focusing and feel fatigue; she had a hard time getting her rings off, she has a hard time flossing her teeth; her full arm was swollen, it's still swollen, minor progress; pain on the inside of her arm; chills; a little bit of soreness at the injection site; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the inside of her arm), PERIPHERAL SWELLING (her full arm was swollen, it's still swollen, minor progress), PAIN IN EXTREMITY (she had a hard time getting her rings off, she has a hard time flossing her teeth), VISION BLURRED (her eyes had a hard time focusing and feel fatigue) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PRAVASTATIN SODIUM (PRAVASTINE) and DILTIAZEM for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (chills), VACCINATION SITE PAIN (a little bit of soreness at the injection site) and NAUSEA (nausea). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on the inside of her arm). On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (her full arm was swollen, it's still swollen, minor progress). On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (she had a hard time getting her rings off, she has a hard time flossing her teeth). On an unknown date, the patient experienced VISION BLURRED (her eyes had a hard time focusing and feel fatigue) and FATIGUE (her eyes had a hard time focusing and feel fatigue). At the time of the report, PAIN IN EXTREMITY (pain on the inside of her arm), PERIPHERAL SWELLING (her full arm was swollen, it's still swollen, minor progress), PAIN IN EXTREMITY (she had a hard time getting her rings off, she has a hard time flossing her teeth), VISION BLURRED (her eyes had a hard time focusing and feel fatigue), CHILLS (chills), FATIGUE (her eyes had a hard time focusing and feel fatigue), VACCINATION SITE PAIN (a little bit of soreness at the injection site) and NAUSEA (nausea) outcome was unknown.            Treatment included Advel, Ice. Eye drops
C/O tingling of left hand and ring finger approximately  30 minutes after receiving  Moderna Vaccine #1.
I got the 1st shot-I have fever, chills, and fatique for 2 days. The 3rd day I had chest pains and high blood pressure and went to the ER. They sent me home. I never felt good. My doctor did an ANA test and it was positive. I have weakness, pain and tingling in my legs, arms, feet and hands. I went to a rheumatologist and they did more testing. I am elevated for Inflammation and was sent to now a neurologist.   2nd dose- hours later I had shortness of breath, numbness in the left side of my chest going down into my left arm. My mom had to call 911 and they sent me to the hospital. I have now made an appt to see a cardiologist because my resting heart rate is low. I have never had issues to this prior.
On Saturday while getting your night medicines from the shelf, and started feeling dizzy, tried to reach the shelf and said to herself that "i can't do it, I just can't do it".  She staggered back and sat down on a towel hamper and apparently fell off of that onto the floor, lost kidney function.  Tried to get up and managed to get her phone out and called her husband (he's hard of hearing - was downstairs).  She said when he got there her head was towards the bathroom door and felt that he could not get in and could not get her up so she tried to get up.  She did not have any strength.  Finally she got up to get on her elbow and crawled into the vanity area and raised up and pulled herself up.  She did not enough strength to walk to the bed.   She got to the bed and then started with chills, turned on her electric blanket.  She felt better Sunday, 1/7/21, and is real shaky today.  She feels a little stronger but is not back to where she wants to be.  Yesterday evening she felt her arm itching a little bit, and looked at it and it was swollen and red, and had an area about the size of her hand.  Her husband felt of it and said that he felt she had fever in it.  The arm was sore to touch.  It is itching a little bit this morning.  She had a headache for a couple of days as well, took a Tylenol one night and her head felt real weird.  It was not real severe, and it hurt more times than it did others.  It would come and go.  Has not taken anything else for these symptoms.   Her husband checked her BP, Friday was 108/62, and last night 106/67.
Headache, Fever,  chills, fatigue Narrative: x1 day after #2 dose fever chills headache
Information ahs been received from a physician concerning a "few" month old female who was vaccinated with a dose of Rotateq (lot number not provided). It was reported that the patient had an allergic reaction. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Tiredness; muscle pain; chills; joint pain; Headache; Fever; injection site pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old 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 arm left on 03Apr2021 at 17:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), dextromethorphan hydrobromide and guaifenesin (ROBITUSSIN DM) and azithromycin (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 6:00, the patient experienced tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise were recovered on an unknown date in 2021.  No follow-up attempts are needed; information about the lot number cannot be obtained.
A couple hours after administration, patient experienced extreme pain in right arm and was taken to the ER that evening. She was hospitalized for 2 days.
White tongue with loss of taste, joint pain lasting 3 days, lethargy lasting 3 days
Noticed eye pain when I turned my head.  Went to Optometrist on 10/25 who performed examination and said everything looked fine and to discontinue contact wear for a few days.  Progressed to blurred vision and headaches.  Visited primary care on 10/31 who referred me to neurologist.  Visit neurologist on 11/01 who referred to ophthalmologist.  Visit ophthalmologist on 11/02 who diagnosed bilateral optic neuritis and referred for testing for Lyme disease, MS, etc.  Had MRI on 11/03, neurologist called to report MRI clear, referred to neuro-ophthalmologist.  In the meantime, progressed to total blindness in right eye.  Have had 3 course of IV steroids, overnight stay in hospital, and am continuing treatment due to condition now steroid dependent.
A lot of hard coughing that could be so hard that it would make me lightheaded and dizzy, chest congestion. I used a home COVID-19 test, it came back positive. I called my doctor, let him know that I was positive, we discussed my symptoms. He prescribed benzonatate, cough syrup with codeine, prednisone and PAXLOVID. I am testing negative just a lingering cough.
Cough; Tired; Pain in arms; Achy; Slow; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis and QUADRIVALENT INFLUENZA VACCINES (FLUAD QUADRIVALENT) for prophylaxis.   On 5th October 2020 17:00, the patient received Shingrix .5 ml, PREVNAR 13 .5 ml and FLUAD QUADRIVALENT .5 ml. On 5th October 2020, less than a day after receiving Shingrix, the patient experienced tiredness, pain in arm, pain and sluggishness. On 7th October 2020, the patient experienced cough. On an unknown date, the outcome of the tiredness, pain in arm, pain, sluggishness and cough were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain in arm, pain, sluggishness and cough to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received Shingrix, Prevnar13, and Fluad65+QIV PFS 2020-2021 on 5th October 2020 at around 5 pm. By nighttime the patient was slow, achy, tired and had pain in arms. On 7th October 2020, the patient developed a cough. The patient's symptoms were not resolved, but symptoms were getting better. This case has been linked with US2020202289 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202289:same reporter
SkinRash c/o itchiness of the lower back with redness noted on lower back and the forehead (between the eyebrows). Hx. seasonal and alcohol allergies that present with rash Narrative: c/o itchiness of the lower back. redness noted on the lower back and the forehead (between the eyebrows). No sob. states hx/seasonal and alcohol allergies that present with rashes. Benadryl given @ 1650: 156/86, 86, 95%O2sat. @ 1700: 163/89, 81, 97%O2sat; @1720: 163/89, 91, 98% O2sat. 1720 redness diminishing, redness to forehead almost gone. In good spirits and denies sob. D'c'd stable to home with friend to escort. Going home, husband home, per pt.
Pt recvd 3 Hep B vax given 1AUG89, 5SEP89, & 9FEB90 following these, titer=5; Pt was given a 4th dose of Engerix-B vax on 15AUG90; Pt seroconverted p/4th dose titer=161; 12AUG91 titer=20;
Started with body/muscle aches that were relatively mild.  By around 7pm, I started shivering which became uncontrollable.  I also became feverish.  The first temperature reading was 99.9 and rose to 101.9.   Called hotline and was told to take Tylenol.  The shivering subsided several hours later (around 2am) but I felt feverish for several hours more.  By around 8am the symptoms had mostly subsided and my temperature was back to normal.  Normally, I would not have been worried but with the COVID-19 pandemic I was concerned.   Ultimately, the episode resulted in nothing more than a lack of sleep for one night.
Pt came to the pharmacy and reported that she got a pain and about 1 and 3/4 inch diameter bruise at the site of injection. It started on the day of injection and the bruise has not gone yet. She said most of pain gone away.
"On the drive home from work after getting vaccinated I started feeling hot and swelling up, probably within 20 minutes of getting the vaccine.  I didn't need to use my EpiPen but the hives started later that day and continued to get worse over the next few days so I went to my provider and was started on prednisone on 5/5.  My symptoms have started improving (5/7).
severe pain in left side of rear head and shoulder. fatigue increase appetite. going on 10 days.
Sweaty; Fever, like 102.9; Nausea; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweaty), PYREXIA (Fever, like 102.9), NAUSEA (Nausea), MYALGIA (Body ache) and CHILLS (Chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) 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) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERHIDROSIS (Sweaty), PYREXIA (Fever, like 102.9), NAUSEA (Nausea), MYALGIA (Body ache) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweaty), PYREXIA (Fever, like 102.9), NAUSEA (Nausea), MYALGIA (Body ache) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 102.9 (High) 102.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up information received on 07 Apr 2021.Added reporter details, second dose details and updated outcome of events.; 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.
cough; flu like; stuffiness and runny nose; nasal congestion; itching; headache; feverish; Tired; Rash; This is a spontaneous report received from a contactable health care professional for a 45 year-old female consumer (patient)   A 45 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Aug2021 (Lot number: FP8448) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Antomical site of Injection: Left Arm, Route: Intramuscular, Batch/Lot number: FA7485), administration date: 10Aug2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Skin Rash", "Itching", "cough", "nasal congestion". The following information was reported: COUGH (non-serious), outcome "recovered", described as "cough"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like"; RHINORRHOEA (non-serious), outcome "recovered", described as "stuffiness and runny nose"; NASAL CONGESTION (non-serious), outcome "recovered", described as "nasal congestion"; PRURITUS (non-serious), outcome "recovered", described as "itching"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "feverish"; FATIGUE (non-serious), outcome "recovered", described as "Tired"; RASH (non-serious), outcome "recovered", described as "Rash". Therapeutic measures were taken as a result of cough, nasal congestion, rash.  Additional information: the patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient did not require medical intervention. Patient was not seen in the Emergency Department. The patient was not hospitalized. The patient was not admitted to an Intensive Care Unit.  Follow up attempts are completed. No further information is expected.
2 days after immunization, induration, erythema, warmth at site of injection 9cmx7cm. Increased pain with movement of upper right arm.
Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.