chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; chest pains across his chest; chest pain is like it is real heavy in his chest area; Lethargic; Headache; diarrhea; Coughing; runny nose; Chills; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 62-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration, administered on 02Feb2021 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. On an unspecified date patient experienced Shortness of breath, chest pains across his chest, chest pain is like it is real heavy in his chest area, Lethargic, Headache, diarrhea, Coughing, runny nose, Chills. patient reported that after his second vaccination he has lingering shortness of breath and chest pains when he wakes up. Caller said that he received his second dose like a month ago. Patient stated he was kind of sick 2-3 days after the second dose. He said that after that he started to notice that he was short of breath and his chest was kind of tight. He said that he started noticing this after the 23Feb2021. About a week later I started having sickness like Coughing , runny nose, headache, shortness of breath, cold chills, body hot , my chest hurt across my upper body and lower stomach, had some diarrheha. The patient underwent lab tests and procedures which included Flu test negative, Strip throat test, Negative, SARS-CoV-2 test Negative, Rapid test (SARS-CoV-2 test) Negative all on unspecified date. The outcome of the events Shortness of breath, chest pains across his chest, chest pain is like it is real heavy in his chest area, Headache, runny nose was not recovered  and outcome of all other events was unknown.   Follow-up attempts completed. No further information expected.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adolescent male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in arm, lip swelling, tingling lips and injection site swelling. BEXSERO was discontinued. On an unknown date, the outcome of the pain in arm, lip swelling, tingling lips and injection site swelling were recovered/resolved. It was unknown if the reporter considered the pain in arm, lip swelling, tingling lips and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in an unknown arm. The physician reported that the patient went to the emergency room and was discharged home and the patient will not received the 2nd dose of BEXSERO. Limited information was provided by the sales representative from the physician. This case has been linked with case US2017026063, US2017026065 and US2017026068 as reported by same reporter.
Rash across middle of back. Painful and itchy. Scattering of raised red bumps surrounded by pink. Lasted two days.
Pt recv vax on 1/15/99; on 1/26/99 pt exp irritable, fever, red dotted rash on legs, arms, torso (behind ears & on head) x 3-4 days; tx=oatmeal baths, Tylenol, Aveeno lotion, Calamine lotion
Fever - left arm swollen - painful arm when moving - headache - vomiting - tachycardia - "shaky".
Patient called in stating she had redness and swelling entire left deltoid and top of shoulder 4-5 inches long and wide. Tingling in left hand between thumb and pointer finger. Started 2 hours after receiving vaccine and still present at time of report 5/21/2021 12:00pm.  Aches and fatigue within first 24 hours that have since subsided.
Expired flu vaccine (intended for 2021/2022) was given for 2022/2023
VOMITED THE ENTIRE UNDISSOLVED VIVOTIF; This spontaneous case (PVX2019-1577) report was received from a nurse on 17-Jun-2019. It describes an 18-year-old adult female consumer who "vomited the entire undissolved Vivotif". The consumer was receiving Vivotif and Prozac for unknown indications.  Case report: The consumer was taking Prozac (fluoxetine). She also took the first dose of Vivotif on 12-Jun-2019. She vomited the entire undissolved medication on the same day.   A follow-up was received on 18-Jun-2019, stated that vomiting persisted even after stopping Vivotif.   Action taken with Vivotif and Prozac was dosage discontinued.  The consumer had not recovered from the event.  The reporter considered the event unrelated to Vivotif while it was related to Prozac.  Company's Comment: In this case, it was reported that the consumer "vomited the entire undissolved Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer "vomited the entire undissolved Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
ARM TENDERNESS OVER 4 TO 5 DAYS; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced arm tenderness over 4 to 5 days. On 02-SEP-2021, the patient experienced massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tenderness over 4 to 5 days on 06-SEP-2021, and massive headache on 05-SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20210923780.
On Sunday on 2/26/23, I started with a runny nose, sneezing and feeling fatigue and tired. I went to bed and woke up feeling worse. I was nauseated and had diarrhea .Took 2 tests and it was positive and called my doctor and he prescribed Paxlovid that Monday at 1 or 2PM in the afternoon. After that finished and on 3/5/23, I had a sinus infection and I was on steroids and antibiotics.  I now have a cough which started on 4/12/23. I  will be starting on a Zpack Azithromycin and Loratadine after another Telehealth this morning .
Redness and severe swelling/pain at injection site. Prescribed prednisone patch and ibuprofen.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-MAR-2016 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (1350U, lot # L036831 with the expiration date 24-SEP-2017, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Light-headed, headache, strong ache in left wrist and fingers and along left leg.
pt had a positive COVID test on 8/24/22 from local Hospital; pt resides in SNF (name of facility not listed in medical records); pt brought by ambulance to ED in cardiac arrest; pt had SOB in SNF, agonal breathing, and lost pulse; ACLS performed; CPR, AED, O2; required intubation; pt passed away in the hospital ED.
The patient received the 5 -11 year old COVID 19 Pfizer vaccine instead of the 6 months - 4years vaccine
Approx 1 hour after injection (arm ok) top of head near crown on left side felt pressure extreme soreness to touch and like nerves were tingling. Did not have any of this before  injection. This went on for rest of evening , all next day.  Next morning was back to normal. Never any severe pain  just pressure and soreness. Got inj. At 3:35 on Tuesday 1-19 2021 started feeling apps 4:30 same day into night. All next day Wednesday 1-20-2021 into night. Next morning Thursday 01-21 it was gone. Could not stand to touch that area on top of head.
Hypotonic, hyporesponsive state, hospitalized for observation on 11/2/00 from 07:00 to 19:00.
Post vaccination at 5:00 PM the pt experienced redness (2/3 circumference of the arm). She also had swelling and tenderness from the shoulder to the elbow , some hand swelling, and pain through out the arm. It was also noted that the pt's underarm is very red. the pt was given antibiotics on 08/16/00  and the pt's arm has improved with the use of Keflex. The pt's swelling had extended below elbow  and remained red until she started the antibiotic.
Breakthrough COVID-19 infection in vaccinated patient: Pt c/o abd pain, cough, congestion, weakness, fever and lethargy. Pt states she has been sick since Monday but abd pain started 2 days ago. Pt has hx of diverticulitis and called in her doctor for amoxicillin prescription which she has had one dose of.  Reason for Hospitalization: Worsening abdominal pain Hospital Course by Problem List:  Patient is a 47 year old female.  She presented to the emergency department with worsening abdominal pain. CT scan demonstrated acute sigmoid diverticulitis complicated by perforation along the posterior margin where there is a 2.0 x 1.7 cm contained perforation/abscess. She was admitted, started on IV zosyn.  Non-operative management was initiated.  WBC normalized yesterday.  This morning she was complaining of mid epigastric pain. CXR was negative, Troponin's were normal, ECG was unchanged from 2 previous ECGs.  Her abdominal pain has resolved.  The epigastric pain was short in duration.  She will follow-up with Dr. in the office in 1 to 2 weeks to discuss surgical options.  She will finish a 14-day course of p.o. Augmentin.  She will continue a soft, bland, low fiber diet until her follow-up appointment with Dr.
25 year old PhD student in program presents with arm redness at injection site 8 days after 1st dose Moderna vaccine 12/31/20.   No immediate side effects except for pain at injection site.  That night was new years and had a couple alcoholic drinks, that night had headache and the next day felt tired.   Pain at injection site lasted 48 hours-similar to flu shot HA and fatigue resolved by 2 days later   Woke up this morning at noticed injection site redness and very mild soreness if she touches.  Not warm, no blisters/vesices/crusts Minimally itchy only in the last 15 minutes  No pain when moving arm No swollen glands in axilla. No other rash or hives anywhere else No facial swelling, dyspnea, wheezing, N/V, diarrhea, lightheadedness, weakness, confusion
I had a chronic cough that last two months, sore throat, congestion. I was only able to take over the counter medication for my cough and sore throat.
Pt's mother called and stated that he had some swelling and fever for 1 day.
pt recv vax 21OCT97 & 22OCT97 pt exp blurred vision;
Injection site reaction when woke up today 10/5/14: 2x3 inches oval shape, red, hot swollen and tender to touch. Applied ice and got better.
About 3 min p/DT inject pt became pale, stiffened & then shook both arms; total time of incident approx 10 sec; pt coherent afterwards; pt had previous hx of poss sz;
Patient had arm tingling shortly after injection. Pt stayed in store for about 4 hours after 2pm injection, no redness or swelling noticed. Pt was quite anxious & nervous (but already has severe anxiety). Pharmacist called patient following afternoon, the 11th and patient noted he was doing marginally better but still sounded anxious. Pharmacist called patient on Fri the 12th 5:16p and this was when the patient explained the following: Muscle stiffness on left side & pain down left leg; cranial pain; shoulder stiffness; nasal congestion; some shortness of breath; soreness & fatigue.  Patient called back and said he had partial shortness of breath at 7:34p on the 12th.  On Sat the 13th at 11am, pharmacist called to check on pt; found him quite agitated & saying, "He feels the shot was botched", noted he had called Janssen to report his issues.  At 4:30pm, pt came to pharmacy, looked fine, arm showed no redness, was more subdued in person than on the phone earlier. He said he was feeling better but was not happy with Janssen and wanted the Moderna 2 series shot because he feels Janssen's vaccine wasn't doing what it was supposed to.
This spontaneous report was received from a registered nurse refers to unknown number of patients of unknown demographics. No relevant medical history of the patients was reported. On an unknown date in 2014, the patients were vaccinated with VAQTA (strength, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that since 18-AUG-2014, unknown number of patients were administered VAQTA which was improperly stored. This was supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Post vax, the pt developed a chicken pox rash on lower back, buttocks, upper thighs, and fever of 102.3. Treated with acetaminophen. Rash lasted one week, fever lasted 2 days. Treated with Caladryl lotion and oatmeal baths, and Benadryl.
then day of the shot patient had chills, sweats, body aches, and fainted. Symptoms resolved the next day.
One week after the vaccinations, the pt developed fever, rash with itching. Used benadryl.
This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The pharmacist stated that there was no record on patient of past history and medications and the patient had "never been a drug reaction".  On 05-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, lot# was not provided) subcutaneously. On 07-AUG-2014, the patient sought for medical attention by contacting the pharmacist and stated that she (patient) had a lump under her skin, swelling, redness but no pain. Pharmacist stated she advised patient to consider cold compresses to the area. No lab diagnostics studies were performed. The outcome of the events was not provided. Additional information has been requested.
left eye is getting puffy after receiving COVID-19 Vaccine today; left eye is getting itchy after receiving COVID-19 Vaccine today; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received BNT162B2 (COVID-19 mRNA Vaccine BNT162B2), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included allergies to a lot of antibiotics. The patient's concomitant medication included Non-specified anti-inflammatory. The patient's left eye was getting puffy and left eye was getting itchy after receiving COVID-19 Vaccine on 21Dec2020. The events were reported as serious, medically significant. She said she is wondering if her left eye getting puffy and itchy is an allergic reaction and if she needs to seek treatment. Reported she did not have a prescription for the COVID-19 Vaccine. Reported her left eye being puffy and itchy has not gotten worse, but her left eye has not improved. Declined any treatment as she thought if she called Pfizer, Pfizer could tell her if she should get treatment. Reported she took an anti-inflammatory twice in the past 2 weeks, clarifying the last time she took the anti-inflammatory was over 4 days ago. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Woke the morning after vaccination to severe abdominal pain, vomiting, severe body aches, lethargy.  Labs revealed elevated liver enzymes and kidney failure on 10/14/2021.  Subsequent hospitalization, treatment, dialysis.
Tired the next day.  Lots of little muscle spasms in my left arm and left eye.
Patient received flu vaccine around 11:30 am.  Patient left clinic and "went to the store" with his wife where he began to feel light headed and "trembly".  He reported slight parasthesia in left leg.  Patient and wife left store and immediately came back to our clinic.  Arrived here again at approximately 12:00 noon.  At this time symptoms still existed, but were milder.  Pt stated "I just don't feel right".  Pt advised to return home and rest, take Benadryl for reaction treatment and Aleve for the aches.  Wife will monitor.  We followed up with a phone call at 4:00 pm and pt states he is doing much better.  He had taken Aleve and Benadryl and symptoms are beginning to resolve.
10/19/2022  morning following vaccine mother said child began projectile vomiting that persisted throughout the day.  Ran fever of 102F.  She took child to walk in clinic and they told her it was a reaction to the vaccine but child did not receive any treatment or medications.  Today remains very nauseated, checks are bright red and has continued to run a fever.
Unexpected, unusually heavy, unusually long menstrual cycle with unusually strong PMS symptoms
Tingling in tongue and lip; This case was reported by a consumer via call center representative and described the occurrence of tingling tongue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tingling tongue. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tingling tongue was unknown.   It was unknown if the reporter considered the tingling tongue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after getting Shingrix, he had tingling in his tongue and lip. The patient stated that  the drug store told him to take Benadryl and was asking if he should be concerned. The patient did not consent to follow up.
This on my 2and vaccine.  Had severe  abdominal pains literally  all day. I did work that day and when I got home and went to bed around 8PM when I got to for work the next day I felt fine. No more aches
2/3/2022 tinitus  in both ears, dizziness, lost right ear hearing
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive -  2 days. In 2021, SARS-CoV-2 test: negative (Negative) Negative - 2 tests. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported she tested negative after 2 days of testing positive. She took the test again, it was negative for COVID-19. No concomitant medication and treatment information was provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information was received from the patient and processed with initial report. Event outcome was updated.
Provider ordered proquad for patient after consult with pharmacy. Patient did not need varicella d/t age per CDC guidelines there for this is a medication error.
Patient presented to urgent care and was subsequently hospitalized within 6 weeks of receiving booster shot. This hospitalization was for complete intestinal obstruction.
Hives, redness, swollen of the arm, fever, itchy, and affected 3 inch ribbon around the arm. Around in the evening was not able to rise arm.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Additional Details: Patient became very confused and lost her memory for about 15 minutes.
This case meets criteria for vaccine breakthrough review.  SxS include non-productive cough, diarrhea, sore throat.
Systemic: small red dots on inside of right elbow-Mild, Additional Details: Patient has not sought medical attention at this time, but has a small red petichial rash on the inside of his right elbow. He thinks this may be signs of capillary leakage that have been reported with the vaccine. I advised he seek medical attention if required. No injection site issues or reactions in left arm.
The patient reported a rash that developed on the arm at approximately day 7 post-vaccination .  It continued to grow, progressing down the arm each day until it reached the elbow.  It never felt warm to the touch or caused any pain.
Chills, fever (possible), severe nausea, vomiting on first day--light headedness, weakness, disorientation on second day--diarrhea started on third day--general fatigue, slight cold symptoms and tingling in left arm after that and continuing (this is 1 week and three days later).
Patient reported to Dr. office on 6/10/08 and reported dizziness, slurred speech and forgetfulness after first vaccine on 3/18/08, no report prior to 6/10/08.
Initial misuse report received from a healthcare professional on 19 November 2013. A patient (no information was provided regarding the patient) had received a dose of FLUZONE given at 5 months, then came in at 6 months and received another with no adverse event, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
MYALGIA ARTHRALGIA INJECTION SITE PAIN BACK PAIN MUSCULOSKELETAL STIFFNESS MUSCULAR WEAKNESS
immediately after vaccination, patient developed arm numbness and weakness. he was monitored at vaccine site x15-20 min and was sent home. when he arrived home about 35-40 minutes after vaccination, that sensation traveled throughout his body. he described feeling weak all over, had lightheadedness, and tingling on his lips and tongue.
10cm x 9.5cm area of redness & induration. Pt. given Benadryl & ibuprofen. HC cream applied to area.
patient developed localized reaction on left arm of injection after 2 nd shot of Shingrix. it looked swollen and pinkish and localized to upper left arm; patient was counselled to take benadryl, ibuprofen, and apply ice pack to relieve symptoms.