chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse via field representative and refers to a 10-weeks-old patient. The patient had an allergy to corn. There was no information about the patient's pertinent medical history provided. On an unknown date in 2018, the patient was vaccinated with PEDVAXHIB lot # R004962, expiration date 20-NOV-2020 (dose, route of administration and frequency were not reported) for prophylaxis and ROTATEQ, orally, lot # R002515, expiration date 13-SEP-2019 (dose and frequency were not reported) for prophylaxis. On the same day, the patient was also vaccinated with PREVNAR and PEDIARIX (doses, routes of administration, lot numbers and expiration dates were unspecified), both for prophylaxis. On 14-AUG-2018, the patient became very fussy, was spitting up and was struggling to poop. The nurse also reported that it was suspected that it might have been an allergy to a corn byproduct as sorbate was a corn derivative and it was in ROTATEQ. The outcome of the events was unknown. The relatedness between irritability, infantile spitting up, dyschezia and the suspect therapies was not reported. The reporter considered drug hypersensitivity to be related to ROTATEQ.
Pt recvd vax & 2 days later exp a severe asthmatic attack & became lethargic; pt was adm to hosp & a pediatric pulmonologist was consulted; attempting to gain further details;
S/s: Diarrhea, vomiting x 2, fever 101 degrees. Tx: Tylenol for fever. ER if fever above 101 degrees of s/s of dehydration.
Client was inadvertently given High Dose Fluzone instead of Fluzone Quadrivalent.
The Sunday before the rash developed I came down with the stomach flu and was throwing up all day. Then I stopped and it followed with a headache on Monday. Wednesday I woke up to an itchy neck that had a blistery rash on my shoulder, neck and clavicle area. The doctor put me in on antiviral and pain relief medication. The rash lasted for 2 weeks. Now I have residual itchy feeling in that area some time.  My husband wasn't feeling well a week ago and tested positive for COVID-19. This past Wednesday 12/14 I I took a test and it was positive. then the Sunday I started with symptoms of runny nose, sneezing, fatigue.
First dose: 11Feb2021 and Second dose: 03Apr2021; Sharp pain in thigh and calf; pain in hip jots; This is a spontaneous report from a contactable consumer (reported for himself). A 73-years-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9267/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Feb2021 at 12:00 AM (at the age of 73-years-old) as dose 1, single and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Apr2021 (at the age of 73-years-old) as dose 2, single; both for covid-19 immunisation at other. Medical history included hypertension from an unknown date and unknown if ongoing and diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for blood pressure measurement, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 has no reported allergies. The consumer reported that, sharp pain in thigh and calf and pain in hip joints from week after first shot to one week after second shot 03Apr2021. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Apr2021.  No follow up attempts are possible. No further information is expected.
REBOUND COVID; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced rebound covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rebound covid. This report was non-serious.
He was fine right after injection. I told him to wait outside the pharmacy consultation room for about 15 minutes to observe any adverse reactions. I cam to help another patient outside the pharmacy for about 3 minutes and I came back I saw my technician helping him to sit down on the chair. His lower lip was bruised and bleeding. I asked her what happened and she said he felt on the floor. I immediately asked if he is ok and told him to sit down on the chair for about 5 minutes. I came back and checked on him. I saw he was sweating on his face and his skin turned pale. I told him that I will call 911. About 5 minutes later, ambulance crew came in but initially he said he did not want to go to ER. He said he might be dehydrated and he did not eat anything before. The crew insisted him to go outside so they can check on his vitals. About 10 minutes later, he was inside the ambulance on the way to ER.
Within 48 hours of vaccine, I developed Parosmia: distorted smell. Many things smell very, very foul, like a rotting compost. Garlic, onions, coffee, all body odors, and many other things have this smell. No sign of letting up.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043214 with expiry date on 30-AUG-2017; dose, route of administration and anatomical location were not reported). Administered doses of vaccine experienced the temperature excursion of -0.24 degree Celsius for 285.5 total cumulative hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), MALAISE (Didn't feel very well) and SWELLING (Swelling). At the time of the report, DIZZINESS (Dizziness), MALAISE (Didn't feel very well) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  includes medicines for asthma. Treatment information was not provided.
7 days after injection,  I woke to the the injection site being red, hot, and incredibly itchy.  I also have felt strange all day - lightheaded and intermittently nauseous and tired.
t103, irritable & splotchy;no sz seen by MD & given APAP;had blood test to r/o meningitis;sx subsided p/3-4 days;
Patient received Pfizer vaccine on 1/26/21 and 2/15/21. Received moderna booster on 1/19/22. Presented to ER on 1/26/22. Three days prior to admission, patient had worsening SOB with purulent sputum and general malaise. Found to be COVID19 positive on 1/22/22. Patient was admitted for COVID 19 pneumona. Her baseline oxygen requirement is room air, however she was placed on 6L of oxygen via nasal cannula upon admission and required high flow at some point. MRSA swab was obtained and resulted negative. She also had a UTI on admission and was treated with zosyn for the UTI and pneumonia. She received decadron and remdesevir as well. Her home medications were continued. Her course was complicated by her paroxysmal Atrial fibrillation with RVR; so she was placed on Amiodarone 200mg daily and lopressor 12.5mg twice daily for adequate rhythm and rate control. Her home propanolol was discontinued. She had increased production of sputum; and with her increased oxygen requirements, pulmonology was consulted. They recommended  Acetylcysteine 10% (MUCOMYST) be added to her regimen. Patient is take nebulized twice daily for the next 1-2 weeks. Ipatropium- Albuterol Duo-neb has been added to her regimen. Patient is to take nebulized twice daily for the next 1-2 weeks. Nebulized saline has been added to patients regimen. Patient take nebulized twice daily for the next 1-2 weeks. Guaifenesin has been added to her regimen. Patient is to take 5-10ML as needed for congestion. She also received some chest physiotherapy.   Patient became clear of COVID isolation. Repeat Chest X-Ray showed significant improvement in lung infiltrates. She had a bout of SVT for which she received a lopressor push IV X1. She began to improve clinically and was weaned down to room air oxygen. She returned back on 2/7/22
About 5 hour after receiving the vaccine I broke out in what looked like pimples/pox all over my torso (stomach, back, chest), legs, and arms. None on face, hands, or feet. Lasted (has not gone away) for 7 day now and has not been getting any better.   Took oral Benadryl for 3 days no change.
more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 28 days have passed, after the first dose was given (1st dose date 13Mar2021)) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
Expired Vaccine. Per Pfizer this is ok to administer before 10/19/22. Patient is fine. Does not need to be re vaccinated.
In the initial 24 hour post vaccination period pt experienced unusual severe pain and tendinitis that caused significant limitation to her left arm. So much so, that she only had about 50% ROM for the first 48 hours post influenza/T-dap vaccine administered on 10/12.  The tendinitis slowly improved and ROM was probably about 75-80% on day 5 put there  still was persistent upper left arm tendinitis causing pain localized at rotator cuff of around a 4 during motion.  Pt was 29 weeks GA. EDA 1/03/2020
employee with erythematous 11 x 16cm area at injection site.  Keflex 500 mg by mouth 2 times per day for 10 days given to patient.
She developed 2 raised, warm, red areas proximal to the injection site. The area closest to the injection site is 48 mm x 62 mm with irregular borders and the second area measured 42mm x 19 mm with irregular borders. No pain or fever. The areas are increasing in size. She was informed to be seen by her provider for further evaluation.
This spontaneous report was received from a Licensed Vocational Nurse, concerning her daughter, a 12 year old female patient. Aside from seasonal allergies, the patient had no other reactions or allergies. In August 2016, the patient was vaccinated with a first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included cetirizine hydrochloride (ZYRTEC). In late October 2016, the patient experienced a sinus infection (sinusitis). She received an antibiotic, azithromycin (Z-PAK), and recovered from the event after three days. The patient received the second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) on November 2016 and did not experience any further adverse events.   The reporter did not assess the relatedness between therapy with GARDASIL 9 and the sinus infection. No product quality complaint was involved. Additional information has been requested.
Temperature to 101 for 2 days after then development of noseoliform rash from head to toe slightly pruritic
Approx 3 min after givnig the inj into (L) delt pt had what appeared to be a seizure. Followed by involuntary arm and leg movement on Rt side, then unable to speak. 911 called. Pt taken to ER.
Reaction to flu vac, red, warm area on Lt arm. 12/9/2009 MD records for visits 10/27 and 10/28/2009, patient reports with c/o's rash on left arm and redness, warmth and induration on rt arm at vaccine site. Tx'd with Zyrtec and topical steroid cream.
Pt reported red, hot swelling around area that started the night of the vaccine that got worse by the time she woke up. Pt went to Urgent Care where she was diagnosed with cellulitis and prescribed doxycycline and prednisone.
The pt experienced a 2.5 x 2 cm area of induration, swelling, variable erythema, slightly itchy. Treated with Benadryl and watching for symptoms of cellulitis.
Patient broke out with rash all over body just a few hours after receiving vaccinations.  Patient went to Urgent Care and was given a steroid shot and sent home with a prescription for a steroid and Zantac.  Mother was also giving Benadryl.
Information has been received from a 71 year old male patient reporting on himself. The patient had no medical history, his drug reactions/allergies included allergy to gabapentin and his concomitant medications included unspecified "blood thinner", unspecified inhaler and ZOCOR. On 16-JAN-2017, the patient was vaccinated with PNEUMOVAX23 (dose, strength, lot# and expiration date were not provided), subcutaneously, for prevention of pneumococcal disease.  The vaccine was administered by a pharmacist through the band aid (product use issue). On the same day, about three hours after receiving the vaccine, the patient experienced soreness and extreme pain and swelling of the arm. The patient stated that he started having trouble breathing therefore, he went to a hospital and was treated by a physician. He was treated with unspecified intravenous steroid and also received unspecified "breathing treatment". The patient was put on prednisone twice since receiving the vaccine. He had also been diagnosed with a respiratory infection. An X-ray was done to determine if the patient had pneumonia however the results were negative. At the time of reporting the patient was still sick and had not recovered.  The causality assessment between PNEUMOVAX23 and the adverse events was not provided. The reporter considered the event of trouble breathing to be life threatening and the event of respiratory infection to be medically significant. Additional information has been requested.
Chills,  body aches, injection site pain,  chest pain,  fatigue,  shortness of breath  decrease oxygen level tachycardia with exertion.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient had no pertinent medical history nor drug reactions or allergies. On 29-AUG-2013 the patient was vaccinated with ZOSTAVAX (0.6t5 ml, once, subcutaneous, lot # J002692 EXP 30-APR-2014). Concomitant therapies included PREMARIN, potassium chloride (manufacturer unknown), LEXAPRO, amlodipine, furosemide (manufacturer unknown), metoprolol, alendronate, losartan (manufacturer unknown), MOBIC, SINGULAIR, COMBIVENT and ADVAIR. The pharmacist reported that the patient developed "red spots" at the injection site after receiving a dose of ZOSTAVAX. The red spots are not painful and not itchy. The patient sought for medical attention but received no treatment. No lab diagnostic studies were performed. The outcome of the "red spots" at the injection site was reported as not recovered at the time of the report. Additional information has been requested.
Reinoculation site 2 cm from initial innoculation along area of derifitis from tape reaction.
Emesis; tem 103F, headache, myalgias within 24 hours of administration; symptomatic treatment.
Weak, runny nose, watery eyes, 99.9 degrees fever, achy muscles, foggy brain (I kept forgetting well known words), mild cough, sore throat.
1 day after my vaccination I was feeling nauseous when I woke up and was experiencing a massive headache than normal. I was also having excessive chills and could barely get up from my bed. I had to call Doctor's office to see what's going on with me. After I arrived at the clinic they had checked my blood pressure and my hypertension level was over 140 so they had to inject me with an IV and had to perform some blood work to check my stats. After 5 hours I was able to fall asleep and woke up feeling pretty normal and fine and my blood pressure was back to normal 120.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and also experienced influenza-like symptoms, refer case US2021AMR254584). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness and influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just had the 2nd dose of newest Shingles shot. The day after 2nd dose, the patient was very sick with flu like symptoms that lasts 24 hours. The patient stated that they did not warn the person about that when you get it. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR254584:Same reporter.
initial 8 hours after vaccine were fine. Fever, Head Ache, Chills, Muscle Aches for next 36 hours. On 2/18 I woke up with a red rash on the left arm below the injection site. It was warm. Dimensions 6"X4". My entire body is itchy including face, neck, legs.
Diarrhea; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of two reports. This consumer reported for a male patient (husband) (unknown age) that who received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 04Feb2021 as a DOSE 1, SINGLE for COVID-19 immunisation. Patient also on EXCEDRIN [CAFFEINE; PARACETAMOL] for an unspecified indication. Patient medical history included migraines. Concomitant medications were not reported. On 05Feb2021 patient experienced diarrhea. Outcome of the event was unknown.   Follow-up attempts completed. No further information expected
Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out of work on 2/1/2021 Went to urgent care on 2/5/2021. I had blood work done
This spontaneous report was received from a healthcare worker and refers to a patient of unknown demographics. No medical history, concurrent conditions, concomitant medications or past drugs of the patient were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiry date and dosing details were not reported). Later, on an unspecified date, two weeks after administration of PNEUMOVAX23, the patient died in an unspecified location from an unspecified cause. Causality assessment was not provided. Upon internal review, the event, death was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: unknown cause of death.
Blurred Vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred Vision) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred Vision). At the time of the report, VISION BLURRED (Blurred Vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication were given by the reporter. No Treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated from unknown.
After receiving 2nd shot of Pfizer vaccine (approx. 3-4 days), began waking with swollen hands.  Also, was unable to sleep/rest and felt that body was in overdrive - this subsided after 3-4 weeks.  Swollen hands continued, then becoming sore in morning, then sore all day, then became quite painful by mid July. July 16th Dr. at loval medical facility rx'd a round of Prednisone for 20 days. July 18th developed Vertigo and still have, which is becoming debilitating. Aug. 4th another doctor rx'd Valtaren for pain, which did not work.  Then rx'd Celebrex and was taking that until Sept. 21st.  Currently on another round of Prednisone. Aug. 12th pain also in feet. *Also have overall feeling of sickness and fatigue, and brain fog.
6 days p/vax pt devel fever, back pain, myalgias, h/a, abn LFT, lymphocytosis, thrombocytopenia;
This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (she had a lump on the neck, near to the clavicle, the second day it got bigger), PAIN IN EXTREMITY (she felt sore on top of her neck and upper arms), NECK PAIN (she felt sore on top of her neck) and PERIPHERAL SWELLING (Her upper arms and armpits had gotten swollen) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.      Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 09-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced NECK MASS (she had a lump on the neck, near to the clavicle, the second day it got bigger). In February 2023, the patient experienced PAIN IN EXTREMITY (she felt sore on top of her neck and upper arms), NECK PAIN (she felt sore on top of her neck) and PERIPHERAL SWELLING (Her upper arms and armpits had gotten swollen).      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.
Metallic taste in mouth, started shortly after vaccine administration (during 15 min waiting time after administration). Persisted for approx 24 hours.
Started feeling dizzy and nauseous after a couple weeks of first dose. I continue to feel dizzy and have brain fog after the second dose.