chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine induced Varicella disease. Patient presented 14 days after Varicella # 1 with rash on arms, neck and chest. Raised red and itchy areas. No fever or other symptoms. Dr. evaluated Patient and confirmed Varicella disease. Patient instructed to take Benadryl for itch and call back with any concerns or questions.
This spontaneous report as received from a healthcare worker refers to a 70 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 08-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L018503 and expiry date 16-MAR-2017) (dose, route and site administration were not reported). On 09-MAR-2016, following the administration the patient could not lift her arm. The patient called the physician's office to seek medical attention. There were no lab diagnostics studies performed. The outcome of the event was unknown. The relatedness between the events and suspect therapy was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; 8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On 28-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jul-2023, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ).    Concomitant medication not reported.   8-year-old child received the vaccine with the dark pink cap for the agent range of 6 months to 5 years by mistake on 28 Jul 2023 child had not shown any signs of distress follow up about an hour after they the office and parent stated no reactions originally received Pfizer monovalent orange cap sk5618 92222.  Treatment medication not reported.
Vaccines received 9/6/18. Contacted clinic 9/10/18 and stated she went to ER 9/9/18 because she had 2 walnut sized lymph nodes to (L) collar bone. She C/O stiffed neck and (L) ear pain. ER prescribed KEFLEX and told her maybe not to get vaccines in (L) arm. She has also made appointment with MD that performed (L) breast biopsy a couple of years ago to make sure everything is ok.
When the immunization was administered- there was quite a bit of bleeding. The immunization was angled down. Patient had itching at the site the evening following vaccine administration. It was noted to be at least 3 inches long of redness and swelling. It was about 2 inches wide as well. This entire area of swelling was noted approximately 1 inch below administration site. There was a purple circle of bruising around the administration site.
Patient became worn down, dehydrated, and fainted the day after vaccination and was taken to the emergency room
No temperature following. Restless at night trying to sleep. Continued Motrin to prevent temperature. Due for next dose of Motrin at 0600 the morning following the vaccine. I took her temp at 0520. It was 99.1. I debated to give her the Motrin early. She then went into seizure at 0521. I called EMS since she has had a complex febrile seizure prior to this one and we always go to the ER because we never know how it will work out. Her seizure was full body lasting 4.5 minutes. Upon arrival at ER fever was 102.9
Developed ITP, platelets dropped to as low as 5,000. Have had to receive IVIG. No known cure.
10/13-sore under right shoulder muscle. 10/16-hand froze up and lost use of hand. 10/20-21-diagnosed Parsonage-Turner syndrome. Under physical therapy.
AS sensorineural hearing loss; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:00 (Lot Number: EN8737) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included bupropion hydrochloride (BUPROPION HCL XL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of  bnt162b2  (Lot number: EN6208) on 13Mar2021 15:30, administered in Left arm for covid-19 immunisation. The patient experienced Sudden AS sensorineural hearing loss likely causing tinnitus possibly related to Covid vaccination response on 04Apr2021 08:00. Event seriousness criteria was disability. The patient presented with hearing loss for 1 month, onset after COVID vaccine which was on 03Apr2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included two separate transtympanic steroid injections, and prednisone medication (60mg then taper). Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Pt recv vax on 11/16/98; on 11/24/98 pt exp pimple like rash on legs, infected knee, sore throat; tx=antibiotic
1. Numbness at tip of tongue 2. loss of taste and appetite 3. fever 4. Chills 5. lethargic 6. ringing in my ears 7. increase in migraine headaches that lasted 6 months 8. one time chest pain 5 days after shot while climbing flights of stairs 9. menstrual cramps on and off for 5 months even though I was post-menopausal.
Itchy; Very hot above shot area; Very swollen above shot area; Big area of redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE WARMTH (Very hot above shot area), VACCINATION SITE SWELLING (Very swollen above shot area) and VACCINATION SITE ERYTHEMA (Big area of redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014Mz0A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE WARMTH (Very hot above shot area), VACCINATION SITE SWELLING (Very swollen above shot area) and VACCINATION SITE ERYTHEMA (Big area of redness). At the time of the report, PRURITUS (Itchy), VACCINATION SITE WARMTH (Very hot above shot area), VACCINATION SITE SWELLING (Very swollen above shot area) and VACCINATION SITE ERYTHEMA (Big area of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated that some events went away after a day and half and then the same symptoms appeared on 15-March-2021.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up information received contains non new significant information. Reporter details updated.
Headache, extreme arm pain, fever of 99.9, body aches, chills, nauseousness, dizzy beginning about 2AM and lasting through next day.  Today 4/29/2021 a few aches in arm and shoulders otherwise much better.
Pt was given Td & pneumonia vaccinations.  10 min later SOB and chest tightness with hives on local reaction.  EPINEPHRINE 0.3mg 1:1000 and BENADRYL 25mg given lm.  Pt. stated back to baseline after 20 minutes.
Injection 10/06/2003: Td administered to left deltoid 16-16:30.  About 3 hours after client had intense headache, pain to left shoulder and arm.  10/07/2003: Redness, swelling to left deltoid and arm.  Fever, twitching, to face and eye.  10/08/2003: Redness and swelling left deltoid decreased to elbow.  Left facial twitching; malaise, treatment: ibuprofen, rest.
Moderna COVID-19 Vaccine EUA I am experiencing intense itching and rash on torso, legs, neck, and scalp. The rash is maculopapular, but sometimes becomes inflamed and looks similar to hives. It is hot to the touch and very itchy--both of these symptoms are more intense at night. I have also observed chilblains are appearing on my fingers.  I regularly experienced chilblains from 2004-2010, but have had none since until now.  I also experienced chills, night sweats, and swollen lymph nodes. I attempted to treat the rash with triamcinolone acetone 0.1%, which was prescribed for a similar condition in the past, and OTC antihistamines, both oral and topical.  I saw my dermatologist on 3/16, who advised me to continue triamcinolone and also gave me a 40mg steroid injection. She believes the rash may be a response to my vaccine. I unfortunately have not experienced much relief yet, and the rash and intense itching continue.  The chilblains, however, are clearing.
8/3/2021: Patient admitted with increased abdominal distention, shortness of breath and decompensated CHF secondary to dietary indiscretion and medication noncompliance.  Patient also has elevated troponin secondary to demand ischemia with a baseline heart failure.   8/6/2021: Patient tested COVID positive; on RA. Had rinus of NSVT 10 and 5 beats. Awaiting temporary HD cath placement. Of note, patient was vaccinated with the Moderna COVID-19 vaccine, last dose administered March 2021. 8/16/2021: Patient still admitted at the time of this report submission
2/6/23 I was coughing and no other symptoms. I took an at home COVID test and tested positive. I had a telehealth appointment and was prescribed PAXLOVID. I started the PAXLOVID that day for five days. I had chills for a couple of days and TYLENOL remedied the chills while taking the PAXLOVID. I was always wanting something hot to drink. I had a very dry cough that was nonstop and lasted for about three weeks. I was unable to produce phlegm. The medications I was taking for these symptoms were guaifenesin and TESSALON cough syrup and ROBITUSSIN.
Area around injection site swelled to the size of a baseball, was hard, red and hot.  Temperature was ~ 101 degrees-could not bear weight or walk for several hours/overnight and next day.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX lot # L040421 15-OCT-2017, L043624 03-NOV-2017 exposed to 5.8F for 114 hours, L049532 08-DEC-2017 exposed to 5.8 F for 114 hours, M006156 05-FEB-2018 exposed to 6.8F for 24 hours. No adverse effects were reported. Additional information has been requested.
i van not do my daily acctiveitys barly stay out of hospital im brain foged so bad cant even keep my times or days i lose months  sometimes over night
sudden onset vomiting, inc temp 104.8 orally 29APR92; 30APR92 hospitalized;
Shortly after receiving the second shot for COVID I got Tinnitus in both ears. It's extremely intense and has NOT subsided over the months since getting the shot. Concerns as a doctors office state there is not much that can be done for Tinnitus.
Patient was injected with his first dose of Moderna and after the needle was retracted some of the vaccine was visualized exiting the injection site and going down his arm. We were unable to quantify the amount of vaccine injected and the amount of vaccine that exited the site and was not absorbed intramuscularly.
Started having fatigue and unrestful sleep/chronic fatigue. Trouble concentrating/thinking/brain fog. Never feels well and rested again.
headache; fever; chills; arm soreness; lymph node enlarged; This is a spontaneous report from a contactable nurse (patient herself). A 62-years-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, in left arm on 04Mar2021 at 09:45 (at 62-years age) as 1st dose, single dose for COVID-19 immunisation. Medical history included high blood pressure. Patient had allergies to penicillin, bee stings, codeine, cheese, nuts. Concomitant medication(s) that patient received in two weeks included verapamil (VERAPAMIL ER); fish oil (FISH OIL); alpha lipoic acid (ALPHA LIPOIC ACID); zinc (ZINC). Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Facility type vaccine was Hospital. Patient had COVID prior vaccination. On 05Mar2021 at 01:00, the patient experienced headache, fever, chills, arm soreness, lymph node enlarged. Since the vaccination, the patient was not tested for COVID-19. Patient did not receive treatment. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
RASH THAT SEEMS TO BE SPREADING. PT ARRIVED AT PHARMACY ASKING FOR REMEDY. PHARMACIST RECOMMENDED BENADRYL TABLETS AND TO SEE DOCTOR IF IT GETS WORSE.
While billing patient's insurance for the Shingrix it was discovered that she previously was vaccinated with Shingrix on 10/1/2021 and 12/10/2021 according the Vaccine Registry.  She now has received a third dose of Shingrix.  Upon speaking with patient, she did report a "lump" on her arm.  She received both a Flucelvax 23-24 and the Shingrix in her left deltoid.
This spontaneous report was received from a physician regarding a 54 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot number, dose and route not specified). The use of this vaccine is not recommended for a 54 year old. Hence there was an inappropriate schedule of the vaccine administration. No adverse events were noted. No product quality issue was noted. Additional information has been requested.
1-2 weeks post vax, the pt broke out with pos greater than 100. No fever associated. Instructed in treatment for chicken pox.
ALMOST PASSED OUT BUT SHE DID NOT; LOSS OF TASTE; LOSS OF SMELL; FATIGUE; MUSCLE ACHE; This spontaneous report received from a health care professional concerned an adult female. 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 not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced loss of smell. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced almost passed out but she did not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, muscle ache, loss of taste, almost passed out but she did not and loss of smell was not reported. This report was non-serious.
Complaint of cough, headache, runny nose/congestion, myalgia and mailais
Rash on her chest and stomach; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-SEP-2023, the patient received Shingrix (left deltoid). On 16-SEP-2023, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash on her chest and stomach). The patient was treated with benadryl (nos) (Benadryl). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The reporter was a patient's husband. The reporter reported that the patient received Shingrix vaccine on Friday.  The reporter stated that when the patient woke up on Saturday morning, she had a rash on her chest and stomach.  The patient took Benedryl on Sunday and the rash cleared up. The reporter did not had the paperwork with lot number and since his wife had not been to a doctor in years. The reporter did not consent to follow up.
Broke out in rash from head to toe and skin became very red and warm to touch.  Child was not as active as usual.
patient presented 2 days after flu shot was given on deltoin region of left arm with a red rash on upper left arm. rash was inflammed and red and was 2 inches below where the flu shot was given. no fever was reported. pharmacist on duty that day counseled patient and told her to take some tyenol if fever presents and probiotics and to follow up with primary care physician if rash worsens. patient has not followed up with pharmacy with course of symptoms since she presented to the pharmacy with the rash.
NauseaVomiting sx similar to Bells Palsey, facial drooping, facial/cheek swollen Narrative:  Previous 2 yrs ago of Bells palsey. Now is c/o of drooling on L side mouth and facial swelling. N/V, sore throat Advised to go to Emergency Room
After my booster around 4pm had flu-like symptoms 103° Fever. MS issue with stiff muscles(lower body only) continued thru the next day. Convulsed the next night multiple times. (about 20 times) Back to normal mostly.
First symptom was headache that would not go away with medicine.  Then after dinner chills started and would not go away even though  I was covered in blankets by a fire.  I was also very tired.  In the evening around 8 or 9 my temperature was 103 and my resting heartbeat was 120.  I took medicine and also put a cold compress on my forehead.  I was able to sleep that night and the next day I had a low grade fever most of the day (99-100) and was tired and a little chilly.  I only took medicine around dinner time and got extra sleep that night.
Vaccinated pt admitted positive for covid infection. No information noted on vaccine place, time, dose, date, manufacturer, etc.
ASYMPTOMATIC COVID-19; 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced asymptomatic covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from asymptomatic covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
key stuck to them like they were a magnet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (key stuck to them like they were a magnet) 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 VACCINATION COMPLICATION (key stuck to them like they were a magnet). At the time of the report, VACCINATION COMPLICATION (key stuck to them like they were a magnet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
Vaccinated 7/30/20 Woke 8/2/20  weakness left hand;worse second digit Referred to neurology. No pain or paresthesia.  Dx: incomplete radial nerve palsy; suspect neuritis secondary to autoimmune response and not due to administration trauma. Undergoing  PT and OT with some improvement
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Weakness-Medium, Additional Details: pt came to pharmacy on 5/1/2023. on her left upper arm has 1 big red rash at the injection side and two small rashes under. She complaint the rash just appeared today 5/1/2023 despite she had her prevnar 20 vaccine on 4/26/2023. Instructed her to do cold compress and see a doctor. Also, instructed her to call back to let us know about dx from her dr.
On 11/30/2021 08:00 pm I was coughing and sinus congestion. Also had body aches 2 to 3 days. Slight fever.