chrisvoncsefalvay/vaers-outcomes huggingface dataset:
symptoms began within 30 minutes; eye burning; itchy throat; chest tightness; dizziness; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (symptoms began within 30 minutes), EYE IRRITATION (eye burning), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest tightness) and DIZZINESS (dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Hashimoto's disease and Hyperlipidemia.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms began within 30 minutes), EYE IRRITATION (eye burning), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest tightness) and DIZZINESS (dizziness). The patient was treated with EPINEPHRINE (intravenous) at a dose of 0.03 milligram; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and FAMOTIDINE at an unspecified dose and frequency.    At the time of the report, VACCINATION COMPLICATION (symptoms began within 30 minutes), EYE IRRITATION (eye burning), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest tightness) and DIZZINESS (dizziness) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD21-026901, MOD21-026902, MOD21-026903 (E2B Linked Report). This case was linked to MOD-2021-029012, MOD-2021-028961, MOD-2021-055838, MOD-2021-055838 (Patient Link).; Sender's Comments:  MOD21-026901: MOD21-026902: MOD21-026903:
"gen rash onset 3MAY97, fever onset 1MAY97 of 105, 5-6 days duration;conjunctivitis;cough;photophobia;"
submental abscess H. Influenza type b cultured from wound; HIB DISEASE, This 5-year-old male received a doses of HIB-Titer; the first dose was administered at a 2 months of age, the last dose was administered at 15 months of age, the last dose was administered at 15months of age. On 10-Jul-98, he was hospitalized with a submental abcess. Culture was positive for H. influenza type b. The child recovered. The vaccine provider submitted this report directly to VARES. Follow-up information received from the vaccine provider on 19-SEP-2000 Indicated that HIB titers on 13-JUL-1998 measured 0.2 ug/ml. On 07-AUG-1998, the child was reimmunized with ACTHIB (Aventis Pasteur) vaccine. Subsequent titers on 09-SEP-1998 measured> 8.0 ug/ml; on 23-Feb-1999 measured 4.2 ug/ml and on 01-SEP-2000 measured 1.3 ug/mL. The physician stated that >1.0 is positive.
pt rxn was a swollen lt axillary node;require some tx;MD spoke w/parent over phone for f/u;pt on ATB
Acid reflux reaction; like something is coming out it is like something is blocking her throat; Acid reflux reaction; like something is coming out it is like something is blocking her throat; This is a spontaneous report from a contactable consumer (reporter's wife) from a Pfizer sponsored program.  A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10May2021 (Lot Number: ER8735) (at the age of 30-year-old) as single dose for COVID-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation.  The patient experienced "acid reflux reaction; like something is coming out it is like something is blocking her throat" on an unspecified date with outcome of unknown.   No follow-up attempts are needed. No further information is expected.
Says has neck pain and throbbing. Was not specific on just how soon this began. No treatment at this time per Dr.
Patient belong to age group that is not indicated for Janssen.  He should be receiving Pfizer instead.
Pt's mother states that the patient developed a fever and redness around the area after the vaccinations, and noticed a knot on his right thigh where the Pediarix was administered about a week ago.
pt admit to hospital with COVID pna 1/18/22 s/p 1 dose of J&J on 4/10/21. No immunocompromising conditions or medications.
SOB, BODY ACHES, FEVER, COUGH, CONGESTION, CHEST PAINT WITH COUGH
diagnosed with central retinal vein occlusion (CRVO); This is a literature report.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypercoagulable workup" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RETINAL VEIN OCCLUSION (medically significant), outcome "recovering", described as "diagnosed with central retinal vein occlusion (CRVO)". The patient underwent the following laboratory tests and procedures: blood test: did not reveal any primary risk factors, notes: did not reveal any primary risk factors that could have explained her disease process; diagnostic procedure: her symptoms deteriorated, notes: significantly and worsening peripapillary hemorrhage; optical coherence tomography: unknown result; visual acuity tests: unknown result; visual field tests: unknown result. Therapeutic measures were taken as a result of retinal vein occlusion.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Retinal vein occlusion  and the suspect drug BNT162B2 cannot be excluded. 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
Left upper arm red, swollen. Mother giving Motrin. Noticed by mother 9/12/07.
Half an hour after shot I started feeling nauseous, there was a golf ball size lump at injection site, my arm had a shooting radiating pain like fire down to my wirst and injection arm feels weak with throbbing pain. Fever set in a few hours later with unconrollable shivering and shaking. The injection site progressively over a few days got more red, swollen and extremely hot to touch. My entire left upper arm by day three is swollen, painful, hot to touch, still weak and red. Within 18 hours I was vomiting and shaking unable to keep any fulids down. Physically I have been on and off with a fever, cold chills and shivering then sweating. Muscle pains, lethargic, foggy headed and have had an on going headache.
TINGLING IN LIPS, RECEIVED 25MG BENADRYL X 2 DOSES WITH RELIEF. ADVISED TO CALL911 IF LIP OR TONGUE SWELLING OR DIFFICULTY BREATHING.
Severe tiredness and fatigue, a bit lightheaded. Was not able to get out of bed for the most of yesterday.  Left arm was very swollen, simply moving it was painful.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient called on 10/3 informing that she has allergy allover her body after getting the flu shot on 9/30. no doctor is needed, she is improving.
This spontaneous report as received from a representatives refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # K009809, EXP date 16-MAY-2015)(dose, frequency was unknown) in the left arm. The patient experienced strong pain on her left arm and was not able to raise it. The patient had search medical attention. The action taken and outcome of the event was unknown. The causality was not reported. Additional information has been requested.
SEVERE VESTIBULAR VERTIGO; VIRAL ATTACK ON THE VESTIBULAR NERVE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced severe vestibular vertigo. On MAY-2021, the patient experienced viral attack on the vestibular nerve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vestibular vertigo, and the outcome of viral attack on the vestibular nerve was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946701.
Fainted in the car, went to urgent care with chest pains, shortness of breath, trouble breathing (needed oxygen)  elevated and rapid heart rate, ringing in ears, numbness in left hand, arm and feet, blotches on arms and legs.
Suspected Guillain Barre (GBS) per PCP. Wed 8/15  -Morning:  headache / drop in energy / APAP -6PM:  skipped dinner / went to bed -Blazing fever (no APAP).  Groin/Testicle pain/ major aches. -Long/bizarre night.  Thu 8/16 -Morning: Felt AWFUL.  Tough to shower. Groin pain/Testicle pain.  Difficult to walk. Lethargic.  Began feeling grip weakness (brief case carry into work).  Shuffling feet.  Sweating.  Took APAP. -Left work ~1130AM.  Went home and went to bed.  Fever -3PM  drove to another town. -Went out to dinner.  Hard time holding spoon.  Feeling better w/ APAP/Advil.  Fri 8/17 -Stayed on couch all day.  IBU every 4 hours ATC. -Groin pain/testicle pain resolving.  Walking improving. -Both hands progressively weak/numb.  Could not write name.  Hands feel cold.   Sat 8/18 -Morning:  Hands incredibly weak/clumsy.  Could not tie shoes/buttons.  Walking better. -Flex arm/bicep = rippling + can't hold contraction.  All muscles (- face) sore.  Especially midline of forearm. -9AM  went to Emergency Department. -Labs showed elevated CPK (750).  Unable to determine cause.  Checked for Rhabdo/urine. Concluded must be viral.  Received 2L of NS.  MD stated it may take a few days to clear. Left feeling horrible.  Hands immobile (swollen).  Sun 8/19 -Felling a bit better. Still problems with hands  a little more coord (minus swollen)  Mon 8/20 -Back to work.  Could not type/write.  Hands feel cold.  Tue 8/21 - Hand weakness tingling, but less.  Right hand improving over left hand.  -through 8/31, significant hand weakness.  Zapping ulnar nerve (mostly left hand).  Yesterday (9/5) / Today (9/6) -Feeling tingly in 1st/2nd digits  especially left hand.  Can fully type and write name.  Hands feel cold and tingly.  Slight clumsiness in hands.
Initial dose received June 5, 2018. Flu like symptoms, headache, body aches began the next day and lasted 2 days. Second dose received January 3, 2019. Due to shortage had to wait for the supply to come in. Same symptoms as first time, except much worse. More severe headache, nausea, no appetite, severe body aches and fever. Most lasted 2 days, nausea lasted 3 days, ending with diarrhea.
Patient's arm shaking, feels like "he's worked out for a long time." Reports blurry vision and trouble seeing. Turned pale and began to pass out. Father and I moved patient to clinic table where upon laying down, patient's head turned to right, eyes rolled back and he had a small, light seizure/convulsions for approx 10 seconds with pupils dilated. O2 98%, heart rate 65, blood pressure 108/76. After rest, was able to drink some water and sit up with complaint of eye and arm pain, Incident began approx 5 minutes after receiving vaccine. Able to walk out of store with parents with no medical assistance needed around 25 minutes later. Followed up with Father around 2pm, patient resting with no new problems to report and no further complaints.
lives in constant pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lives in constant pain) and HEADACHE (slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Back injury and Knee pain (Patient had been in need of a total knee replacement since before starting the series but had not been able to have the surgery due to the Covid-19 pandemic.). Concomitant products included LEVOTHYROXINE, MELOXICAM, ROPINIROLE, METFORMIN, SIMVASTATIN, GABAPENTIN, OXYBUTYNIN, LOSARTAN and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN (lives in constant pain) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK dosage form. In 2021, HEADACHE (slight headache) had resolved. At the time of the report, PAIN (lives in constant pain) outcome was unknown.            The patient reported that the concomitant medication losartan was a replacement for previous enalapril therapy. The patient mentioned having previous weird side effects to the referenced past enalapril therapy. The exact date of the enalapril therapy's discontinuation and specific weird side effects experienced were not provided.   This case was linked to MOD-2021-162122 (dose 1 case) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Telephone Contact Report (TCR) received on 30-06-2021 was caller did not give email. Patient was provided number to report further details
Information has been received from a nurse concerning a 23 year old female who in May 2009, was vaccinated with the first dose of GARDASIL (0.5ml, IM). On 13-JUL-2009 the patient received the second dose of GARDASIL (0.5ml, IM, lot# 661953/1130X, site: deltoid). There was no concomitant medication. On 13-JUL-2009 the patient fainted in the office after receiving her second dose. The patient woke up right away and she was fine afterward. On 13-JUL-2009 the patient recovered. Follow-up information has been received from a registered nurse concerning a 23 year old female with no known drug allergies who on 13-JUL-2009 at 10:50, was vaccinated with the second dose of GARDASIL (0.5ml, IM, lot#662518/2287Y, previously reported as lot# 661953/1130X) in her right deltoid. On 13-JUL-2009 at 10:50, the patient fainted "stubbed toe". The patient revived immediately. The patient had blood pressure checks for 1/2 hour. The patient drove home. On 13-JUL-2009 the patient recovered. No further information is available.
A couple days after I received my second vaccination shot I started to experience heart palpitations, chest pains, shortness of breath as well as trouble sleeping.
I had a bad cough more than anything. I didn't have a fever at all. I went to the doctor, and I was diagnosed with Acute Bronchitis and a Sinus Infection. They prescribed prednisone, doxycycline hyclate, and benzonatate. I am feeling better, but I am still dealing with a cough. It isn't as bad as it was, I am able to sleep now.
Pfizer-BioNTech COVID-19 Vaccine EUA: six months after vaccination patient presented to ED cough, chest congestion, and chest tightness but afebrile and not hypoxic or ill-appearing. Diagnosed with pulmonary embolism and COVID-19 positive.  Prescribed anticoagulation and discharged medically stable. On follow-up clinic visits patient recovered and continuing chemotherapy.
Redness, swollen, area around injection site 4.5cm diameter, LT upper thigh hives.
Longstanding chest pain and related issues including dizziness, memory issues, back pain.  Fluid around heart.
Second dose scheduled 22 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 22 days after first dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 22 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 22 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Woke up and both legs were inflamated. Walked with difficulty. A day after at the time to sleep, couldn?t sleep because have difficulty breathing. Continually have leg inflammation and pain when walking and affects my waist. Venous inflammation in legs are visible since then.  Negative thoughts after the adverse events.
This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, dose and route not provided). Other suspect therapies included on an unknown date, influenza virus vaccine(manufacturer unknown). On an unknown date, after receiving PNEUMOVAX 23 with influenza virus vaccine (manufacturer unknown) the patient developed swelling of the arm. At the time of the report, the swelling of the arm was unknown. This is one of two reports received from the same source. Additional information has been requested.
Upset; Left arm hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurts so bad) and FEELING ABNORMAL (Upset) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurts so bad). On an unknown date, the patient experienced FEELING ABNORMAL (Upset). At the time of the report, PAIN IN EXTREMITY (Left arm hurts so bad) and FEELING ABNORMAL (Upset) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Bell's Palsy; Soreness in arm; Cries all the time; Can't eat or drink right; Doesn't want to go out in public; Swelling; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm), CRYING (Cries all the time), FEEDING DISORDER (Can't eat or drink right), SOCIAL AVOIDANT BEHAVIOUR (Doesn't want to go out in public), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). The patient was hospitalized on 14-May-2021 due to BELL'S PALSY. At the time of the report, BELL'S PALSY (Bell's Palsy), PAIN IN EXTREMITY (Soreness in arm), CRYING (Cries all the time), FEEDING DISORDER (Can't eat or drink right), SOCIAL AVOIDANT BEHAVIOUR (Doesn't want to go out in public), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: Diagnosed with Bell's palsy.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included steroids, eye drops, and eye ointment which was given at the emergency room  It was reported that the patient was not taking any prior concomitant medications.  The pharmacy where she received her first dose told her she should not get the second dose.  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.; 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.
I am an ER RN.  I received the vaccine at work, only hours before leaving for a 4 week visit to my home out of town.  On my way home I stopped at the grocery store and was overcome by such a wave of weakness I could barely walk back to the car.  I then stopped at the post office, had to lean on the wall to gather strength to walk in, and as I came through the door, the postal worker saw me and asked "ma'am, are you okay?  Do you need help?"  I assumed I was having a reaction to the flu shot and told her I'd be fine.  Although we were supposed to leave when I got home, I told my boyfriend that I felt too bad and had to nap.  As I lay on the bed, I felt pain begin in the injection site and radiate about 4 inches in all directions.  At the same time all of my joints, especially in my hips, began to burn, and all of my muscles, especially in my arms and legs seemed to get even weaker.  I noticed that when I talked, I could barely talk, I could move my jaw, but my upper lip hung limply.  If I had not just had my flu shot, I would have gone to the ER, thinking that I was having a stroke, but I knew the onset was so soon after the shot and so dramatic that the 2 events must be related and I thought I was having a bad but normal reaction.  I slept for about an hour then forced myself to get up and into the car.  My boyfriend drove while I sat, too weak and limp to even put my hands in my lap, my arms just hung at my sides.  About 50 miles away he stopped to get food but I told him I was too weak to eat but wanted a drink.  When he got a soda for me, I found that it was too heavy and I couldn't lift it to drink. By 8 pm when we stopped for supper, the worst of the symptoms had subsided;  I still felt weak, but was able to ambulate and eat.  I felt normal by the next morning.  On Nov. 9th, I took ACLS and one of the nurses mentioned that she felt bad after her flu shot.  When I described my reaction, a 3rd nurse told me of the similarity to Guillain-Barre, and after looking it up, I thought I should report it.
Skin rash and irritation, itching on forearms.  Fatigue/malaise lasting three days