chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash in her left arm; red bumps and itching over the area of size similar to a base ball; red bumps and itching over the area of size similar to a base ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash in her left arm), VACCINATION SITE SWELLING (red bumps and itching over the area of size similar to a base ball) and VACCINATION SITE PRURITUS (red bumps and itching over the area of size similar to a base ball) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 78C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE RASH (rash in her left arm), VACCINATION SITE SWELLING (red bumps and itching over the area of size similar to a base ball) and VACCINATION SITE PRURITUS (red bumps and itching over the area of size similar to a base ball). At the time of the report, VACCINATION SITE RASH (rash in her left arm) was resolving and VACCINATION SITE SWELLING (red bumps and itching over the area of size similar to a base ball) and VACCINATION SITE PRURITUS (red bumps and itching over the area of size similar to a base ball) outcome was unknown.            Reportedly, Consent for safety follow up by the patient was granted.  Patient had used Ice to treat the symptoms  Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-310822 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non-Significant F/U Case.
Patient received HPV and Varivax in left arm. Immediately after patient stated her left arm was numb and she couldn't move it. She was observed x about 30 mins, after about 15-20 mins she said her left hand was cold with white blotches on palm and redness up her arm. About 10 mins later her hand was pink again, her arm felt heavy but hand had feeling and arm with F ROM. VARES form filed on 1/17/08, this is second form b/c patient returned on 1/18/08 with large red patch at site of vaccine-possible cellu;tis-She was put on KEFUX.
Sleeplessness due to muscle cramping in leg & ankles.  Inabiity to stand steadily upon rising. Lightheadness, dizziness, hip, leg, ankles aching all of next day.  Chills, slight fever, swollen neck glands.  This lasted through most of the next day, Resulted in using a walker to move from room to room. Restless 2nd night and same inability to stand steadily.. Felt well enough to take a shower, but felt faint and had to get out before finishing.   Better sleep and better standing on day 3.   Everything seems back to normal.
A migraine started 5-6 hours after the injection. The migraine has not gone away yet. My neurologist has given me multiple medications to try. None of them have given me any relief yet. It is severe enough that I have not been able to work since receiving the vaccine.
armpit on the side he got the vaccine is swollen and sore; armpit on the side he got the vaccine is swollen and sore; This is a spontaneous report from a contactable consumer (patient's mother).   A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (Batch/Lot Number: EW0187) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Family medical history relevant to AE(s) was reported as none. There were no concomitant medications. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Patient's mother reported that on 10Jun2021 her son's armpit on the side he got the vaccine was swollen and sore. She asked if this was normal. The caller stated her son got the vaccine on Wednesday and asked how long he should wait to go see the doctor about this symptom? The event armpit swollen and sore was reported as worsened. The seriousness of the events was assessed as non-serious. The patient did not undergo any relevant tests. Caller stated he (patient) has not gone to the doctor and has been putting it off and wants to know if she should go. The outcome of the events was not recovered.   Additional information has been requested
Patient received second covid vaccine. He states he had no side effects from first vaccine. After second vaccine he experienced light headedness, dizziness, and was clammy. He did not pass out but was close.
I consider my symptoms to be mild. A lot of congestion and general physical discomfort but no fever, just general discomfort and congestion.
Pt developed hives about 5 hours after vaccinations, improved with Benadryl.
RECEIVE SHOT SECOND DOSE 4/3/21..AT AROUND  8 AM..AROUND 1 PM FELT TIRED AROUND   1 PM. RESTED FOR 15 MINUTES. WAS OK TILL 8;15 PM WENT RIGHT TO BED..TOOK TWO TYLENOLS    AND ZYQUILL...WAS FRIGIDLY COLD, SHAKING...WOKE AT 12 AM...SWEATING PROFUSELY FOR TWO TO THREE HOURS..DRANK WATER THROUGHOUT..BECAME   VERY NAUSEOUS.     SLEPT HARDLY THAT    NIGHT.. SUNDAY MORNING SHOWERED,  WANTED TO GO TO EASTER MORNING MASS..WAS VERY TIRED..MASS AT 8;30..BY NINE  I ASKED MY HUSBAND SEVERAL QUESTIONS WHEN THEY WOULD DO THIS AND THAT..HE SAID THEY HAD..AFTERWARDS HE TOLD ME HE LOOKED OVER AT ME...AND MY  EYES WERE GLAZED OVER... I REMEMBER GOING TO COMMUNION.    DID NOT KNOW HOW TO     PUT HOST INTO MY MOUTH...DID SO ACKWARDLY. CAME HOME WENT TO BED SLEPT OFF AND ON...SUNDAY NIGHT I TOOK ZYQUILL TO SLEEP...DID NOT    SLEEP ALL EVENING NAUSEOUS ALL EVENING..NOW I HAVE NO APPETTITE, DRINK ALOT OF WATER...EAT VERY LITTLE, BUT    FOOD I WOULD NOT NORMALLY EAT. RETURN TO WORK ON MONDAY..STILL IN A FOG...I FIND I     SAY STUPID THINGS TO    PEOPLE I WOULD NOT NORMALLY DO..DAY 3... ALITTLE MORE ENERGY, BUT STILL VERY TIRED..STILL NO APPETITE...STILL  NAUSEAOUS .DO NOT LIKE. LOST OF MEMORY...OR THINGS BEING SAID THAT I WOULD NOT SAY..
The patient reported dizziness and neck pain (pt reported similar feels of having a stroke), went to the ED on 1/16/2021
has a dry mouth; been itching all over her body,still itching from the top of her head to the bottom of her foot; her right dominant  arm is hurting after receiving the dose of the vaccine in that arm; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (has a dry mouth), SOMNOLENCE (Sleepy), PRURITUS (been itching all over her body,still itching from the top of her head to the bottom of her foot) and VACCINATION SITE PAIN (her right dominant  arm is hurting after receiving the dose of the vaccine in that arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (opioids like pain medications), Drug allergy (morphine), Drug allergy (codeine), Drug allergy (sulfur), Drug allergy (steroid), Drug allergy (Demerol), Drug allergy (Lortabs) and Drug allergy (promedol.). Concomitant products included METOPROLOL, LEVOTHYROXINE, CLONAZEPAM and VITAMIN D3 for an unknown indication.    On 30-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SOMNOLENCE (Sleepy). On 30-Oct-2021, the patient experienced DRY MOUTH (has a dry mouth), PRURITUS (been itching all over her body,still itching from the top of her head to the bottom of her foot) and VACCINATION SITE PAIN (her right dominant  arm is hurting after receiving the dose of the vaccine in that arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DRY MOUTH (has a dry mouth), SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (her right dominant  arm is hurting after receiving the dose of the vaccine in that arm) outcome was unknown and PRURITUS (been itching all over her body,still itching from the top of her head to the bottom of her foot) had not 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.   Patient had taken three caps of Benadryl and has  went to ER and got a benadryl shot. Patient stated that the medication made sleepy and was still itching from the top of head to the bottom of the foot.
On August 20th I began to experience nerve pain in bottom back teeth, by August 21s it was my whole mouth and over the last few weeks progressed into have constant pain/aching teeth, jaws and sinus area with an feeling of inflammation in the jaw area.   Difficulty speaking, headache and I am abnormally and without control extending my lower jaw out.    I have seen the Dentist, which confirmed there is nothing wrong with my teeth.  I have been see the PCP who referred me to the ER or Advance UC, and then Neurology.  I am currently pending a visit with Neurology.
Twitching of left arm, weakness, nausea, headache. Tingling in feet.
I was previously healthy and had no serious health problems besides common seasonal allergies. I started having problems immediately after receiving the COVID vaccine, which included rash, chest pain, swollen lymph nodes in breast area and arm pits.  6 months later I was hospitalized for sepsis and sinus infection, I was in ICU for 4 days and was told by several physicians that I could have died due to the severity of the infection. Then recently I was hospitalized again for Bell's Palsy.
Patient developed hives the evening of receiving vaccine. The next morning the patient noted her lips were swollen and the hives had progressed. The patient ate Indian food for the first time on the evening of 6/8/01.
trouble lifting arm above her head; Itchiness; Tiredness; Arm Pain/injection site soreness; injection site Redness; Low-grade Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced tiredness, pain in arm, injection site erythema, fever and pruritus. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with paracetamol (Tylenol). On 4th April 2019, the outcome of the tiredness and fever were recovered/resolved. On 6th April 2019, the outcome of the injection site erythema and pruritus were recovered/resolved. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain in arm, injection site erythema, fever, injected limb mobility decreased and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix dose right arm and felt tired and had a low grade fever for 2 days. The injection site being red and sore for 4 days, but has had continuous arm since vaccine.  The arm pain as continuous that sometimes goes up or down arm extending to arm pit resulting in trouble lifting arm above her head.  Her internist recommended using ice or heat for relief and reports it minimized pain minimally, but currently she still had arm pain The reporter consented to follow up.  The patient's internist advised caller not to receive 2nd dose. The outcome reported for all adverse events in the structured field of xml is recovering and recovered/resolved with sequel instead of recovered and not recovered (outcome uploaded in Argus)
Information has been received from a Licensed Practical Nurse referring to a patient of a unknown age and gender. On 23-FEB-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K015979, expiration date: 23-SEP-2016, dose and route were unknown) (-7.5 degree centigrade for 3 hours). No adverse effects were reported. No previous temperature was excursion. Additional information has been requested.
Swelling in left ankle. Elevated ankle. Swelling went down after a few hours.
fatigue; low grade fever; chills; This is a spontaneous report from a non-contactable consumer (patient herself). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Mar2021 (Batch/Lot Number: EN6205) at the age of 50 years as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient had no known allergies. There were no concomitant medications, no other vaccine in four weeks, and no other medications in two weeks. On 07Mar2021 06:00, the patient experienced fatigue, low grade fever, and chills. No treatment was required for the events. Outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.
About 4 months later, I began to get whelps on my skin that look like bug bites. They are very itchy and come amywgere from 1 to 7 on arms and legs.
immunization techs gave a patient the vaccine and it was dripping down patient's arm with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 75 years old female patient and reported that immunization techs gave a patient the vaccine and it was dripping down patient's arm with no reported adverse event , it involved  vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , once (formulation: injection) (lot number and expiry date: not reported ) via intramuscular route in the left arm for immunization.  On 07-Sep-2022 the patient developed a non-serious event of " immunization techs  gave a patient the vaccine and it was dripping down patient's arm with no reported adverse event " (accidental exposure to product) (latency: same day) .  It was reported " One of the immunization techs gave a patient the vaccine and it was dripping down patient's arm, as patient felt it go down their arm. Pharmacist stated that it was dripping out the side of the needle where you put the syringe. Pharmacist states she was not there the day it happened and doesn't know if the needle was not on tight enough or if the product had a crack in it but the product dripped out of the side of the needle."  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fatigue, memory loss, hearing hyper-accuity, photophobia, visual disturbance.
Upper right arm pain at injection site that has progressively gotten worse. Pain radiates from injection site area to shoulder causing limited range of motion and severe pain.  Physical therapy.
PT RECEIVED PNEUMOVAX VACCINE ON 6/1/13.  ON 6/2/13 PT NOTED PAIN AND ERYTHEMA AT THE SITE OF THE PNEUMOVAX INJECTION.  CELLULITIS PROGRESSED, AND PT FEBRILE.  ON 6/4/13 INFECTIOUS DISEASE CONSULTED. VANCOMYCIN IV ADDED TO COVER MRSA, LEVAQUIN ALSO CONTINUED.  OVER THE NEXT 24 HOURS THERE WAS A REMARKABLE IMPROVEMENT OF THE CELLULITIS. VANCOMYCIN CONTINUED UNTIL 6/7/13.  PT DISCHARGED 6/7/13 WITH DOXYCYCLINE TO COVER POTENTIAL MRSA.
I had low-grade fever, cough, and fatigue for several days. On Dec 27th, I was tested positive for COVID-19.
p/vax first day weak, shaky, 2nd day hives then since then 10 days recurrent chills, sweats, arthralgias, presyncope feelings;still sx today;
On 02/17/2021, swimming laps and severe headache occurred.  EMS called.  Transported via ambulance.  CT done.  Negative for Subarachnoid hemorrhage.  Discharged home.  Headache continued.  On 02/20/2021, seizure at home.  Transported via EMS back to hospital.  CT repeated.  Subarachnoid hemorrhage on CT.  Coiling of aneurysm at that time. Three weeks spent in Neuro ICU.  On 03/09/2021, basilar artery had severe spasm, emergent ballooning of basilar artery done.  Discharged home on 03/16/2021.
Stroke; Sleeps all the time; Extemely Tired; A spontaneous report was received from a consumer concerning, 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced stroke, was extremely tired and slept all the time.   The patient's medical history was not provided. No concomitant product was reported.   On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   As per reporter patient had been extremely tired and slept most of the day since injection. On 17-Feb-2021, patient experienced stroke. Magnetic resonance imaging confirmed stroke. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events experienced stroke, was extremely tired and slept all the time were considered unknown.; Reporter'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.
Sudden onset Tinnitus.   Turned on like a light bulb Feb 4 2021.  Has stayed consistent ever since.  Annoying high pitch squeal around 11.3KHz.   Both ears equally.   Visited doctor.  Tried various diet changes.   Checked hearing and had audiologist testing/consult.
Fever, croup, wheeze - onset day after vaccine of low grade fever, sudden onset the next evening of stridor, barky cough & wheeze, Temp max 102.6. Per note h/o RAD. No asthma known.
1 WEEK  post injection; developed intense itching at injection site  diffuse redness around site and swelling   that has lasted so far 48 hours now
Immediately after injection, patient began to feel hot, nauseated, and anxious.  She vomited x3.  Upon arriving to the observation room, patient reports that all symptoms have resolved.  Monitored for an additional 15 min with no complications.  Pt ambulatory to private transportation.
Several pt devel redness at the inject site following the vax. Additional reports to be generated.
Received doses from a vial after been punctured 20 times; Received doses from a vial after been punctured 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received doses from a vial after been punctured 20 times) and PRODUCT ADMINISTRATION ERROR (Received doses from a vial after been punctured 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received doses from a vial after been punctured 20 times) and PRODUCT ADMINISTRATION ERROR (Received doses from a vial after been punctured 20 times). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received doses from a vial after been punctured 20 times) and PRODUCT ADMINISTRATION ERROR (Received doses from a vial after been punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Reporter stated that 24 patients received doses from a vial after been punctured 20 times.
Approx. 5-10 minutes after receiving vaccination, subject became light-headed and pale. She was placed in a supine position, given orange juice and a cool wet towel was placed to forehead. Her BP-90/60. After 5 to 10 minutes, she felt better and was able to sit up. BP-remain 90/60. About 5 minutes later, standing BP-90/60.
Affected area greater than quarter on 25/Mar/2021; Affected area smaller than quarter on 24/Mar/2021; Redness at injection site which is hot; Itching on arm; Hardness at injection site; Swelling at injection site; Injection site is hot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arm), VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021) and VACCINATION SITE INDURATION (Hardness at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (allergy to cipro).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (Itching on arm), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 24-Mar-2021, the patient experienced VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021) and VACCINATION SITE ERYTHEMA (Redness at injection site which is hot). On 25-Mar-2021, the patient experienced VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021). At the time of the report, PRURITUS (Itching on arm), VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site which is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
My Dad found he could not sleep that night until nearly 6 am. He tossed and turned but only slep a couple of hours. Mind racing, but no restless legs syndrome. The next day, he had no soreness at all, but he woke up constantly all night and couldn?t settle to sleep. That happened for the subsequent  5 nights after the vaccine, he just got short naps. On Tuesday the cardiologist said he could safely take melatonin ( he also tends to low bp) and he took 10mg tap(last 5 mg time released). He woke up frequently but was able to get back to sleep. He has been taking that tablet most nights and sleeping better.
Left arm at injection site became red and hard and appeared to have a rash. My throat on the left side was also swollen.
Scab and redness at injection site that opened and reappeared surrounded by redness size of quarter appearing 3 weeks after injection and lasting for 3 weeks. Area still tender.