chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin assessment was done observed area w erythema, warm to the touch, but no symptoms of infection. Case was consult with the primary case physician who recommended to document the reaction on medical record. And Erythema.
chills; fever; sweating; really achy; This is a spontaneous report from  a contactable consumer (patient) .A male patient of an unspecified age (reported as 29) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose number unknown, single for COVID-19 immunisation.  The patient's medical historyand concomitant medications were not reported. On 26Feb2021 (Friday), night, patient got chills, fever, sweating a lot and was really achy. At the time of report, since 26Feb2021, he had been waking up soaked in sweat. He enquired whether these side effects were normal and how long do these symptoms would last and when should he need to reach out to an HCP and whether a COVID  test need to be taken. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the client's second COVID vaccine, sometime in mid February, the client started noticing his eyes itching. His tears started feeling like acid, and will leave a rash where they have been. Client is having a rash on the right side of his head, and on the backs of both of his hands. He went to his PCP who advised to take Benadryl daily. Client reports the symptoms are ongoing and have not resolved.
Moderate upper arm swelling, redness, and pain, nausea, myalgias.
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L001456 with expiration 22-OCT-2016; lot # L014419 with expiration 15-APR-2017; dose, frequency and route were not reported). No adverse effects were reported. Additional information has been requested.
Pt recv vax on 10/31/98; on same day pt exp chills & chattering teeth; 11/1/98-pt arm sore, swollen, red, rash ; 11/2/98 pt imp
Patient presented to ED on 3/4/21, 3/8/21 and both times subsequently hospitalized. Patient also admitted to the hospital on 3/11/21 and 3/25/21 and has been hospitalized ever since.
On the day after vaccination, patient was pale, dizzy, tired, and fainted. Mother called and went to ED. Vitals and tests were normal and she was discharged home. Patient is feeling better, but remains tired.
COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: No" (unspecified if ongoing), notes: Known allergies: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: I tested positive for COVID again with all the symptoms; (Aug2022) Positive, notes: Treatment of COVID-19. Antiviral drug was taken as therapeutic measures for drug ineffective, covid-19 from 24Aug2022 to 28Aug2022. Patient took no other medication within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
(OMIC). A report was received from a physician of seizure coincident with FluMist. A seven year old female with a history of febrile seizures, received FluMist on 9/14/06. The next day she developed a low grade fever and later had an episode of seizure. The events happened while the pt was on vacation with her family. The reporter was notified of the events one week later. According to the reporter, the pts mother called their office to notify them of the event one week after it occurred. The pt was seen by a relative pediatrician who was with them at the time. No treatment was reported. The pt is not taking any anti convulsant medications. The reporter also noted that in the past, the pts mother reported episodes of seizure even with just a low grade fever. The pt recovered from the seizure on 9/15/06 and recovered from the low grade fever on an unreported date. No further episodes of seizure was reported. The reporter also added that the pt received the varicella live vaccine Varivax on the same day that she got FluMist. She also said that in 2004, the pt received FluMist without any reported adverse event. The reporter causality was not provided.
5SEP91 TC from Mom 2PM, PT crying all night & fever 104; 5SEP91 seen in ER, t105, & BOM; 6SEP91 appointment w/MD, t101; 13SEP91 TC to Mom, PT is fine now;
1st dose of Covid 19 Vaccine (03/09/21) within a minute after the Vaccine she felt light headed and very tired, that feeling continued and felt very tired and then that same day; 1st dose of Covid 19 Vaccine (03/09/21) within a minute after the Vaccine she felt light headed and very tired, that feeling continued and felt very tired and then that same day; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had 1st dose of covid 19 vaccine and within a minute after the vaccine she felt lightheaded and very tired, that feeling continued and felt very tired and then that same day, she woke up again and with the same feeling. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
0944 Dizziness VS 114/67 ,P 71, says 98% glucose 98. 0958 left for home with family. Dizziness resolved
Diagnosed with and tested positive for COVID 19 on 12/20/21 and 12/31/21.
Tested  positive  for COVID-19 06/29/2022 I received my 4th dose on 04/19/2022 and my COVID-19 symptoms started on  06/27/2022 around 5:00-6:00 I had headache; I was feeling very tired.  I did a home test on 06/27/2022  it was negative.   on 06/28/2022 i had a sore throat.   on 06/29/2022 i woke up with severe sore throat. and I had a nasal congestions which was hard for me to breath. I took a test right way on the same day which was positive. I called in the morning and did a tele health in the evening. They prescribed me PAXLOVID 5 days.
Vaccinated 2/4/21. On 2/5/21 in the AM, she developed a dull headache, sore throat and injection site pain/swelling. She felt that the pain went into the lymph nodes and into her back. The headache, pain and sore throat worsened over the afternoon. By the time she got home at 4:30pm she had whole body aches and was feeling really bad. She developed facial and eyelid swelling. She applied ice. Her eyelids swelled so much that they cracked. Her face has a dry, red rash. She later got up to take bedtime medications and she passed out. She began vomiting. She declined an offer to call the ambulance or to go be seen by a doctor. She took tylenol for pain and zofran for vomiting. On 2/6/21, she developed diarrhea. She was
Background: The currently recommended single dose of the PPSV23 for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the PCV13. Methods: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination. Results: Following the enrollment vaccination, OPA titers were significantly greater in the PCV13 group compared to the PPSV23 group for 10 of the 12 serotypes common to both vaccines and to serotype 6A which is unique to PCV13. Responses were noninferior for the other 2 common serotypes. Responses to PCV13 given at 1 year were generally lower in the group that received PPSV23 at enrollment. Conclusion: In adults aged 70 years and older previously vaccinated with PPSV23, PCV13 was significantly more immunogenic than PPSV23 for most of the common serotypes and for serotype 6A. The OPA responses after a follow-on dose of PCV13 one year later indicate that a prior dose of PPSV23, but not PCV13, diminishes the response to the subsequent administration of PCV13. This report refers to a 81 year old male patient enrolled in a study. "At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination." The 81-year-old male was in the group that received PPSV23 (manufacturer unknown) as the first dose and PCV13 as the second dose. 132 days after the second vaccination the patient experience idiopathic thrombocytopenic purpura (ITP) which was the only serious adverse event considered by the investigator to be related to the study vaccine. The ITP resolved after treatment. Additional information has been requested.
Fever ranging from 99.1 degree to 100.1 degree, Continuous Pounding headache, weakness, Nausea and vomiting Lasting 24 hrs. deltoid down to the fingers.
Mom stated that patient had Karate for an hour the night of the vaccines and that he was complaining he was really tired and a little sore.  The next day, mom said he was still a little achy and tired.  Today 09/08/2022 1603 mom called and was concerned cause her son was complaining his throat felt dry and he just needed to take a drink.  Denies any other sickness, nor heat exposure or increase play in the heat nor sports.  Mom said he doesn't usually say his throat is dry and he needs to drink.  No other symptoms reported. Denies SOB, nor chest tightness, nor fever.  Encouraged mom to f/u with her PCP to make sure there are no other concerns the Doctor would want to know., and to go to ER if he feels closing of the throat, facial numbness, or difficulty breathing.
Urticarial eruptions on trunk, with itching and fussiness. BENADRYL elixir produced improvement in rash and symptoms.
About a month after injection in my upper left arm. I started losing strength in my left arm, couldn't pick up a glass of water. I went to see my Doctor to rule out a blood clot. He sent me to get an ultrasound. The results are that I have cysts in my arm causing me to be in pain every day. I was advised to see a surgeon to remove the cysts. I am trying homeopathic regimen before I do that. So far nothing is happening to relieve the pain in my left arm. I now have a other joints that are painful.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Patient had vasovagal episode followed by vomiting. Went to hospital s\p vaccination and help there overnight for observation. Released 3/28/2021- in AM
Fever that wont break, intense body aches/pain from head to toe, headache, sweats, aches, chills, fatigue. Intense soreness at injection site. Arm pain started a couple of hours after. Fever and body pain started about 8 hours after and has yet to cease. Could barely sleep last night I was in such pain
Severe eye itching, rash on various parts of both, at urgent care that felt the rash I have on my right hip buttocks is "shingles".
Information has been received from a physician concerning a female patient with a history of convulsion who was vaccinated with a first dose of Gardasil (lot # "unavailable"). Concomitant therapy included unspecified therapy. The physician reported that the patient developed "seizures after receiving her first dose of Gardasil." It was reported that the patient had "been having seizures before Gardasil was administered." Unspecified medical attention was sought by the patient. The outcome was unknown. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Patient was given 0.5ml instead of 0.25ml booster 3rd dosage, patient was called on 1/19/2022 and states was sick for 3 days with fever, fatigue, and cold symptoms but nothing else since. Patient was sent a letter informed of  dosage that was given
The patient received the vaccine at 10:10 AM after 15 minutes complained of feeling some tightness in the throat. Patient able to speak clearly, no SOB noted. O2 sat at 98%, heart rate at 106/min. The patient was monitored closely for 30 mins more during that time; she complained of headache, tiredness, and stomach pain. The patient?s father confirmed the patient is allergic to other fruits. During this time, O2 sat was between 98% and 99%, heart rate between 86/min and 108/min. The patient calmed down and said she felt better, health education was given to dad, and the patient was encouraged to drink plenty of water and rest. Dad was instructed to continue with monitoring. O2 sat99% and heart rate 96% when the patient left the clinic with dad.
pt had a previous hosp admission with left femoral neck fx; had a positive COVID test during that hospitalization - asymptomatic and was dc'd to Hospital; began to have increasing respiratory distress  with fever and was brought to other Hospital; on Vapotherm; given steroids, remdesivir, ABX; had another positive COVID test during this hospitalization; DNR/DNI; pt's condition worsened and she passed away in the hospital
Pt recvd vax 21JUL93 & on 22JUL93 pt had a rash on head & upper trunk; also skin felt cold; had no react @ inject & no irritabiity; pt is afebrile; office visit scheduled for 23JUL;
Left arm into left chest wall tender to touch. Difficulty lifting arm. Fever, Nausea 4/4/04. AM
difficulty breathing; This case was reported by a consumer and described the occurrence of difficulty breathing in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty breathing. On an unknown date, the outcome of the difficulty breathing was not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had difficulty in breathing. The reporter asked would this go away or did need to see doctor.
Pt. arm swelled up 1 day after shot administered she had to see a doctor who gave her doxycycline antibiotic.
Numbness in lips; Tongue tingling; Lips became swollen and tingling; Lips tingling/tingling in lips has not completely resolved; Tongue became swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips became swollen and tingling), PARAESTHESIA ORAL (Lips tingling/tingling in lips has not completely resolved), SWOLLEN TONGUE (Tongue became swollen), HYPOAESTHESIA ORAL (Numbness in lips) and PARAESTHESIA ORAL (Tongue tingling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced LIP SWELLING (Lips became swollen and tingling), PARAESTHESIA ORAL (Lips tingling/tingling in lips has not completely resolved), SWOLLEN TONGUE (Tongue became swollen) and PARAESTHESIA ORAL (Tongue tingling). On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numbness in lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, SWOLLEN TONGUE (Tongue became swollen) and PARAESTHESIA ORAL (Tongue tingling) had resolved. At the time of the report, LIP SWELLING (Lips became swollen and tingling), PARAESTHESIA ORAL (Lips tingling/tingling in lips has not completely resolved) and HYPOAESTHESIA ORAL (Numbness in lips) 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up was received on 12-MAY-2021. Additional event- numb lips was added and events- tingling lips outcome was updated to not recovered/resolved. Reporter's email was added and address was updated.
no other AE reported; The nurse stated the expired product was given to a patient today; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 27-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella virus vaccine live (PROQUAD)( lot # S000622, expiration date: 06-JUL-2020)(dose, strength, route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # S005088, expiration date: 27-SEP-2021) (dose, strength, route of administration were not provided). The measles, mumps, rubella and varicella virus vaccine live (PROQUAD) had no temperature excursions in the past. There was no other adverse event reported.
Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it; hallucinations; appetite was off; bowel movements were off; feeling weak; strong sense of smell; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002BNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Hypertension, FAMOTIDINE and EZETIMIBE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinations) had resolved and DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak), PAROSMIA (strong sense of smell) and PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it) outcome was unknown.        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.   Treatment information was not provided.  Patient's second dose was scheduled at 4Jun2021 but still its pending  Company Comment   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.
Headache, followed by congestion build up and runny nose, tightness of chest, and irritation in skin of face though not visible.
PATIENT CAME IN ASKING IF WE ADMINISTER THE COVID VACCINE WHICH WE INFORMED HER THAT WE DID.  SHE WAS ALSO INFORMED THAT WE HAD AN EXTRA DOSE DUE TO A CANCELATION AND OFFERED TO HAVE HER TAKE IT AT THAT TIME (3/25/21).  SHE WAS EXCITED AND AGREED.  WE DID THE PATIENT QUESTIONAIRRE WITH HER AND THE QUESTION WAS ASKED IF SHE HAD RECEIVED THE COVID VACCINE BEFORE IN WHICH SHE ANSWERED NO.  ALL QUESTIONS CHECKED OUT OK SO SHE WAS GIVEN THE MODERNA VACCINE AT THAT TIME.  ON 3/26/21, A FAMILY MEMBER OF HERS CALLED TO ASK IF SHE CAME THE PREVIOUS DAY AND RECEIVED THE VACCINE.  WE EXPLAINED HIPPA TO THEM AND ASKED THEM TO GET HER ON THE PHONE TO VERIFY WE COULD DISCUSS THAT INFORMATION WITH THEM.  Pt WAS CALLED ON 3 WAY AND VERIFIED THAT SHE CAME  ON 3/25 AND RECEIVED THE VACCINE.  THE FAMILY MEMBER THEN INFORMED ME THAT SHE HAD RECEIVED THE 2 DOSE SERIES OF THE VACCINE PREVIOUSLY.  I THEN DISCOVERED THAT ON 1/8/21 SHE RECEIVED HER 1ST DOSE OF PFIZER COVID VACCINE AND ON 2/3/21 SHE RECEIVED HER SECOND DOSE OF PFIZER. I WAS ALSO INFORMED THAT THE PATIENT IS IN THE EARLY STAGES OF DEMENTIA, BUT SHE DID DRIVE HERSELF TO THE PHARMACY AND SHOWED NO SIGNS OF NOT BEING ABLE TO ANSWER QUESTIONS ON HER OWN ACCORD.  SHE HAS NOT SHOWN ANY SIGNS OF ANY ADVERSE REACTION TO RECEIVING THE MODERNA AFTER RECEIVING THE PFIZER OVER 7 WEEKS PRIOR. I SPOKE WITH MY REGIONAL VACCINE COORDINATOR AND EXPLAINED THE SITUATION IN WHICH I WAS DIRECTED TO COMPLETE THE VARS.
Unable to close right eye, seen at ED rx prednisone 50 mg, po, qd x 4 and antifacial tears.
Became hot & dizzy w/ solid red rash over upper lt arm, nausea. Ice pack applied. BP 138/80; P 100;  10 min later BP 140/60; P 96 ; R 24. No SOB, Wheezing, rash becoming worse, extending to shoulder, cheeks, bilat temporal area, chest, etc.
Vaccine was given 7 days past beyond use date. Per Pfizer their data stated, "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
Nausea, headache- constant pressure, feet feel like blocks of ice, temperature is 2degrees above normal, chills, fever blisters inside mouth, sore arm at injection site, pins and needles feeling in my fingers and fingers are swollen-  can close my fingers but tight and lightheaded .
Systemic: Dizziness / Lightheadness-Severe, Systemic: vertigo exacerbated by positional changes-Severe, Additional Details: Pt did not have this reaction to the prior two doses. Instructed mom to bring pt to be evaluated to r/o inner ear issues, cardiac issues, etc. Pt had a rheumatologist appointment a few days after the vaccine and issue was not directly addressed by provider. Problem still persists even almost a week later. Pt unable to perform a fair amount of ADLs.