chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot adminstered on 06-23-04 in the right thigh no adverse reaction noted at this time.  06-24-04 Mom called and said that the injection site was swollen and redbut patient was himself in no distress, not cranky no fever. Per Dr. apply warm compresses and continue Tylenol for pain.  06-25-04  9:00 a.m. mom came to clinic and stated that the patient leg was real swollen and had a rash down the right leg.  Told mom child needs to be seen by the doctor.  Mom broght patient in and Doctors description was patient alert and happy, about 10mmX10mm +for erythemia and +for mild tenderness. Interpretation Adverse Effect to Vaccine. Plan Inform VAERS, discussed reaction with parnet, tylenol and warm compresses PRN, F/U prn.
Pain at the injection site  fatigue headache mild to moderate muscle and joint pain chills fever flu-like symptoms
(L) arm w/warm/red/swollen 3 x 3 cm patch, tender to touch. Tx: KEFLEX 250 mg/5ml 1 tsp 3x/d x 7 D, re-eval in 4 d.
pt recvd vax; 2 1/2 hrs later, cried for 4 hrs straight & could not be comforted; pt also had loud high pitched crying during this periods;
Weakness in her forearms since October 7 2018, numbness in her left hand, she likes it in time to the pneumonia and flu vaccines. No treatment plan initiated by provider at first mention during visit on 10/7/18. "Hand weakness. Current Assessment & Plan Unclear as to relation to PREVNAR 13, she will be evaluated by neurology. Should this proved to be an adverse reaction, will need to report. Pt then went to ED on 12/14/18 see below #1 myasthenic crisis. Patient decannulated on 1/12/2019 tolerated this well. Patient has road test today and was satting 96% on RA with ambulation. No need for home O2. CT scan in ICU showed no evidence of thymoma. She is has completed another 5 day course of IVIG whilst on the medicine floor. Continued management with the assistance of the neurology service. Continue on pyridostigmine as outpatient. Plan for outpatient repetitive nerve stimulation. Recommendations from Neurology are for follow up with Dr. for repeat IVIG in one month. Urgent referral has been placed. Saw Neurology on 1/17/19. Currently on mestinon 60 mg q 6 hours (waking up to take it even when asleep.) Was not placed on steroids by report. Since being at home started to have some excess salivation, coughing, dry heaves/nausea. Fortunately no falls. Ambulation seems more difficult due to her hip issues. No choking but cautious. Supposed to be scheduled for outpatient PT but she has been slightly more fatigue. Patient is now on O2 concentrator at home.
pt recvd vax & following inject screamed continuously for 6 hrs then slept for 2-3 hrs, nursed, slept & seemed recovered; 24 hrs later projectile vomiting of 8oz formula; taken to FMD; temp nl pE nl; no treatment; has been well since;
Pt rec'd H1N1 Nasal Vaccine and a few hours later had chest redness on skin with mild dyspnea which resolved prior to ED visit.
Swelling, redness, bruising, severe arm pain, itching, hives even 5 days later.
very tired; sleeping alot; dizzy spells; diarrhea; This is a spontaneous report from a contactable consumer. A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 04Feb2021 13:30 (at the age of 74-years) as SINGLE DOSE in Arm Left for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included Lung cancer (lobectomy), copd, emphysema. The patient previously took Pcn (penicillin), codeine, morphine, Indocin and had drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On 05Feb2021, the patient experienced very tired, sleeping alot, dizzy spells and diarrhea. The patient did not receive any treatment. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was not recovered.
EE sts COVID 19 vaccine #2 taken 1/9/21 approx. 2 hour later developed a red itchy rash to L foot from toes to mid calf, R foot only to ankle, B/L ears and B/L dorsal hands. EE sts took 50 mg Benadryl and Melatonin and went to sleep. EE sts at appx 9pm took Benadryl 25 mg for itching. EE sts symptoms resolved and have not returned since 10pm 1-10-21
Information has been received from a physician concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on unspecified dates was vaccinated with a  first and second dose of GARDISIL (lot# unknown).  The physician reported that there was no adverse event with the first and second dose of Gardasil.  On 08-AUG-2007(previousl reported as 08-AUG-2007) the patient was vaccinated with a third dose of Gardasil (lot# unknown) injection in the left deltoid.  On 09-AUG-2007 the patient called the office and reported that her arm was injected became numb from the shoulder to the wrist area.  Medical attention was sought.  On an unspecified date a scan of the patient's arm was performed with results not reported.  The physician believed that the injection was given too high in the patient's arm and that may have been the cause of the patient's arm going numb.  No further adverse event information was given.  Follow up information was received. 07-AUG-2007 the patient developed increasing pain in the left shoulder on motion. On 09-AUG-2007 the patient had an MRI of the left shoulder. The impression was sizable joint effusion with evidence for subacromial/subdeltoid bursitis as well as edema within the infraspinatus muscle near th myotendinous junction. These findings may be related to muscle strain/partial tear involving the infra-articular left shoulder injection. Recommend correlation with history of any attempted therapeutic left shoulder injection. At the time of reporting on 21-SEP-2007 the patient had improved 80-90%. Additional information is not expected.
Two days later - Neuro side effects and mast cell inflammation -  pins and needles through body and subsequent muscle twitching. Off and on hot and cold sensations in left lower leg.  Anxiety and insomnia.
Seizure following vaccinations on 3/19/07. Pt received Tdap, Varicella, IPV, Hep B. Patient had one seizure on 3/19/07 and a second seizure on 3/21/07. 04/17/2007 MR received for ER visit for 2nd episode of seizure activity in 2 days. Initial event occured 2 hours after vax and lasted ~2 minutes.  The event today which resulted in ER visit lasted ~15 min. PE: WNL. DX: Epilepsy vs. non-epileptic events.
PT HAD A RASH BREAKOUT ON HER INJECTION ARM THAT RESOLVED IN A FEW MINUTES
patient received the fisrt dose at 14 years old / The patient is now 22 and did not complete the series of vaccinations / patient wants to continue vaccination; No additional AE; This spontaneous report was received from a nurse practitioner, referring to a 22 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the 14 year old patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, for prophylaxis (strength, route, frequency, lot# and expiration date were not reported).  At the time of reporting, the patient was 22 year old and did not complete the series of vaccinations. The patient wanted to continue with vaccination. No additional information provided.
ON 4/15 had an anaphylactic reaction and went to the ER at medical center (throat closing and body swelling) saw MD, no admittance sent home, provided bendadryl, steroids and Pepcid . No blood work or scans. On 4/16 had collapsed/fainted at home. Went to ER at different medical center. Saw MD Just gave fluids, CT scan and chest X-ray and blood work. sent home.
101 fever for almost 2 days after shot; chills; pain at injection site; felt lethargic (resolved after 48 hours) chest and back pain beginning 6 days after vaccination when taking a breath.
Presented with left-sided chest pain 2 days after second dose of vaccine. Remained afebrile. Elevated troponin levels and EKG suggest myopericarditis. Echo showed normal ejection fraction. Received Toradol and aspirin at outside hospital, and then received ibuprofen at ED. He is now stable and under close cardiac monitoring.
Extreme pain in left arm beginning 2 days after vaccine and continuing ten days later.  Pain does not lessen with Advil or Icy Hot.  Unable to sleep at night.
The evening following receipt of vax, the pt experienced a screaming reaction. Subsequently the pt recovered from the screaming reaction. Three other pts had similar experiences. (WAES 99120436, 99120443 and 99120438). No further information is available.
This spontaneous report as received from a pharmacist refers to a 54 year old female patient with multiple sclerosis and no drug reactions or allergies. On 07-JUL-2014 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (0.65ml, once, lot# J014811, expiration date 21-FEB-2015). Concomitant therapies included oxycodone, LYRICA, morphine, and REBIF. On 08-JUL-2014 reported as "the day after", the patient experienced a raised red rash that was warm to the touch at the injection site and "surround area". The reporter stated that the reaction got "progressively worse" on 08-JUL-2014 (reported as "yesterday"). On 09-JUL-2014 (reported as "today"), the patient came in to the pharmacy to seek guidance with the pharmacist. The pharmacist stated that he recommended the patient take BENADRYL and topical hydrocortisone for treatment. There was no lab diagnostic test performed. The outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
After I received the vaccine, I began to experience pain and tenderness at the injection site almost immediately. Later that night I began to feel extremely tired so I went to sleep but woke up with chills a few hours later. A short time later I noticed that my neck was stiff and my tonsils began to swell a little. I also developed a slight fever of 100.6 and had headaches throughout the day. I called my doctor and asked if I could come in and if it is okay for me to continue breastfeeding my 5 month old. I was told that if my symptoms persisted or got worse, then I should come in but that I should take Tylenol, drink plenty of fluids and get as much rest as I can and that it was perfectly fine for me to continue to breastfeed my son. The effects lasted about 2 days the worst of it being within the 24 hours of receiving the vaccine.
Patient has had a tactile fever, nausea, myalgia, chest pain and severe headache.
Pt reported mild soreness to arm after injection on 3/16/2021 which resolved in a day or two. States he worked out in yard over the weekend and woke up the next day with moderate pain in arm but not at injection site. Describes pain to be in tricep region. States he has taken otc pain reliever with minimal relief.
cried for solid 3 hrs p/vax given; mom did not let anyone know until time for 4mo shots 17APR95;
The vaccination provided was expired by one month at the time of vaccination.  No adverse effects were reported.  Re-vaccination  per CDC guidelines was recommended.  After the patient consulted with her OBGYN the patient was revaccinated in the other arm with a new lot of Adacel that was not expired on 12/29/2021.
On April 1, my arm was sore which was normal, and I didn't think much of it because it was like that for my first dose. That night I started getting chills and it was so bad I was shivering and extremely tired. That lasted until mid-day on April 2. The following week, I started getting heart palpitations. I went to my PCP who did a stress test and echocardiogram and then sent me to cardiologist for checkups and they put me on a heart monitor for a month. Everything has been fine, and tests didn't show anything so they don't know if it was stress related and couldn't definitively tell me what caused it. He also put me on statin drug because my cholesterol is crazy. I still have palpitations but nothing like I had back in April.
1 AM 2/2/11 - R Thumb red, swollen, numb, hard to move and itchy. 3 PM 2/2/11 - middle fingers R and L hand numb, itchy neck, sl. rash and itchy belly. Took benadryl on own. 2/3/11 AM - R thumb sl. swollen and electricy feeling in hands bilaterally. 2/4/11 tingling starting to subside and MD seen on 2/3 feels not vaccines but a "pulled" nerve Per pt.
DALLAS RECEIVED HEP B, POLIO, PNEUMOCOCCAL DISEAS, DTAP, AND HIB. THE INJECTIONS WERE GIVEN AT 4 PM ON 6-18-2009, WITH IN 12 HOURS HIS LEGS WERE COVERED WITH RED RASH. WHELPS WERE EVIDENT AT THE SITE OF INJECTION ON BOTH LEGS. WITHIN 24 HOURS RASH WAS HEAD TO TOE. ON THE 21ST OF JUNE RASH IS RAISED. FEVER AND FUSSINESS ALSO OCURRED WHICH IS COMMON WITH ALL IMMUNIZATIONS.
Case number PHEH2015US024500 is an initial spontaneous report received from a consumer on 20 Nov 2015. This report refers to a 62 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157904) intramuscularly on 16 Nov 2015. It was reported that after five hours of vaccination the patient experienced chills, fever, aches and pain. She visited physician on 18 Nov 2015, where they confirmed positive for influenza A and B virus. The outcome of the events was reported as condition improving. The seriousness and causality of the events were unknown.
Severe left arm pain, stiffness.  Left shoulder pain.  Neck pain.  Stated she couldn't lift her left arm for three days after the vaccine.  Low grade fever. Reported feeling disoriented, sweating, no appetite for a couple days.  Fever has resolved, but other symptoms still remain.  Advised employee to call doctor to report symptoms and get advise regarding next vaccine.
I felt fine after receiving the vaccine, but on May 24, 2022, I wasn't feeling good so I went to the Clinic. I had a fever of 99.9 degrees, a sore throat, and a headache. I tested positive for COVID, and I was prescribed PAXLOVID. My symptoms lasted for about 5 days.
Student has warmth at site, fatigue and bilateral rash to skin on distal orbits.  First dose had given student fatigue and headache. Student concerned about a building reaction to series.
Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) 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 EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 4th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Rash started 8/13/10 at 1200 pm at vaccine site rash progressed. On 8/14/10 pt had fever at 103 degrees at 8pm, pt took OTC TYLENOL, fever reduced to 100.7. When seen at clinic, pt is to take OTC MOTRIN 2 tabs q 6 hrs prn for fever and to follow up in 48 hrs. Rash & swelling to varicella & TDAP sites only on right arm.
Left delt site red @ site with tenderness (smaller than 50 cent piece) 10-28-09. 10-29-09, site increased to baseball size. Mom advised to continue ice compression, take ibuprofen & BENADRYL.
Nausea, Vomiting, Lethargy, Diarrhea, Headache
Initial report received from a health care professional (medical assistant) on 28 May 2010: This patient was vaccinated with MENVEO (batch number: 100001), (dose: unknown) intramuscularly on 28 May 2010, instead of combining the diluent component of MENVEO with the lyophilized component, the patient received only the diluent component of MENVEO. No adverse effects were noted after this administration.
Immunization card stated that child allergic to pertussis,  Dtap given. No adverse symptoms reported post injection and nine days later.
Swelling, redness, warm to touch. Mild pain. (Possible cellulitis per ER visit 9/28/18).
Patient became severely disoriented, lost hearing, pale, after vaccine administration. Called 911 but after evaluation, patient did not go to the hospital with 911 team.
Localized erythema to MMR, VZV, and polio injections. Benadryl given at 12:00 PM and erythema was already decreasing, prior to Benadryl being given. No induration or difficulty breathing.
After 10 minutes of vaccination, patient was sweating and dizzy. Ambulance team arrived check the vital signs which were stable.  Patient was alert and conscious at the movement.  He indicated that he wanted water. The ambulance team allowed him to drink about 1 sip (10-15 ml) of water.  Then he had tachycardia.  Then ambulance took him to  the hospital. His wife was with him.
Stomach pain, chills and fatigue were experienced after about 16 hours.   After a few more hours, a headache set in. These symptoms lasted about 24 hours.
I was traveling on 8/1/2021 and I started having symptoms on 8/6/2021. I did a Covid test and it was positive. We drove so we just got back into the car and came back home to quarantine.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 20-NOV-2015, the patient was vaccinated with improperly stored VARIVAX lot # L015045 dose number 1. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Second shot vaccine was end of Jan 2021 chills that lasted 48 hours, I lost appetite the next day for 24 hours, I continued working, I started getting headaches and ringing in ears I perceived this as hypertension and it lasted 2-3 weeks, losartan 12mg per day,  I checked it and it was high it?s never been that high so I took 24mg instead. I took 50mg total of losartan and it?s taken until now to get down to 25mg daily. I may have been exposed in Jan of 2020.
I did not have an adverse reaction to the vaccine. I went to my doctor for a routine body check, and they found something on my nose. They took a biopsy, and it was cancer. I have not had surgery yet but it is scheduled.
administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number abxb59aa, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The medical assistance reported that the patient was administered with an expired dose of Bexsero. The adverse event was not reported. The patient's identifiers was not provided. Additional Supportive Information: The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Lumps in her body caused by the calcifilaxis became inflamed and very painful.; Lumps in her body caused by the calcifilaxis became inflamed and very painful.; Lumps in her body caused by the calcifilaxis became inflamed and very painful.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included calcifilaxis (unspecified if ongoing); calcium restricted (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (First Dose), for COVID-19 Immunization. The following information was reported PAIN (non-serious), INFLAMMATION (non-serious), MASS (non-serious), outcome unknown. Therapeutic measures were taken as a result of pain, inflammation, mass.  My sister has calcifilaxis and is calcium restricted. She said that after her second shot, the lumps in her body caused by the calcifilaxis became inflamed and very painful. So much so, that she had to have surgery to remove some of them.  The lot number for bnt162b2 was not provided and will be requested during follow up.
blood running down from his shoulder to his biceps; left a dark bruise for 2 weeks afterwards; This is a spontaneous report received from a non-contactable consumer (patient). A 6-decade-old male patient (in his 50s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient was getting his 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, he saw blood running down from his shoulder to his biceps. He said that the vaccination provider wiped it out, and put pressure on it. It stopped bleeding, but left a dark bruise for 2 weeks afterwards. Since there was blood, he wanted to know if it was possible that the vaccine was injected into a blood vessel. He also wanted to know if there was a possibility that he did not receive enough dose, and the vaccine may not be as effective as it should be. He wanted to know if there was a standard procedure for when he suspects that he did not get a full dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt woke up at 1am with headache, joint pain, sore arm, mild swelling at injection site, fever 101 degrees; Reported to pharmacy at 9am, symptoms had not resolved at all.  Advised to treat symptoms with acetaminophen/NSAIDS as necessary
1. High heart rate - resting rate :100-112 BPM and walking (inside house) rate -120BPM- lasted 2.5 days  2. Fever and chills- lasted 2.5 days 3. Runny nose and sneezing within 30 minutes of vaccine- lasted 2.5 days