chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant regarding possibly 3 patients of unknown age and gender. The GARDASIL vaccines were exposed to temperatures between 32F and 34F for 10 days on 02-MAY-2016, 09-MAY-2016, 10-MAY-2016, 13-MAY-2016, 17-MAY-2016, 19-MAY-2016, 20-MAY-2016, 24-MAY-2016, 25-MAY-2016 and 28-MAY-2016. There was no previous temperature excursion reported. On an unknown date approximately in 2016, the patients were vaccinated with improperly stored GARDASIL (lot # M004116 expiry: 12-OCT-2017). No adverse effects were reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
itchiness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (itchiness in her arm). At the time of the report, PRURITUS (itchiness in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown). On  unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route and lot # not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Lymphadenopathy cervical; This case was reported by a physician via sales rep and described the occurrence of lymphadenopathy cervical in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, 2 days after receiving Bexsero, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was unknown.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and had palpable lymph node around clavicle. The physician did not know whether this was a known a known side effect. The reporter agreed for follow up.
1FEB93 cried unconsolably a little over 2 hrs, inject site red; leg swollen, warm to touch around inject site; APAP given;
Swelling noted to inside of mouth and lips progressed to swelling in the throat accompanied my fever, chills, body aches. Benadryl taken 50 mg q 6 hr. All symptoms resolved within 12 hr.
She became diaphoretic, passed out and seemed to have a seizure. She was given some water and vitals were taken and stable. She left with her husband and was advised to take it easy today and drink lots of fluids
Narrative: Patient admitted for COVID-19 despite receiving two doses of Moderna vaccine. Patient was eventually transferred to ICU and intubated. Patient remains in ICU at this time.
Arm pain extending the length of the arm through the fingers Fever 101.7 Body Aches
she attributed to pollen allergy; flu; cough; fever; headache; she is presenting suspected COVID symptoms.; she is presenting suspected COVID symptoms.; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of an unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 14Mar2021 she had cough and symptoms that she attributed to pollen allergy. She stated that she had headache and fever on 14Mar2021, feeling like she was going through the flu. It was reported that she had her second dose of vaccine scheduled on 25Mar2021 and currently she was presenting suspected COVID symptoms. The events were considered as non-serious by reporter. The events suspected covid and drug ineffective was considered as serious (medical significant). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient had 15 cm mass on her L upper arm for one month, painful and limiting range of motion.
A non-serious spontaneous report of administration to child under two years old was received from a health professional concerning a 23-month-old male. Neither the patient's medical history nor the concomitant medications were reported for this patient. On 22-Dec-2011, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 02-Apr-2012: it was reported that the child received FLUMIST 10 days prior to his second birthday and had no adverse events.
Got an immediate head ache in the parking lot, drove home and fever, dizziness, and extreme fatigue began.  Muscle and joints aches along with head aches and mental fogginess persisted over the next three weeks.  Fatigue and occasional sleeplessness also continued for the next 3 weeks.  All of the symptoms that I had during a 2 week long bout of covid that I had in July of 2020 came back although the nausea was not as extreme.  The joint and muscular pain in knees and neck and back still have not let up entirely and it has been almost 6 weeks now.
Initial report received from a healthcare professional on 20 November 2012. An 84-year old male patient, who was allergic to PCN (Penicillin), illness at the time of vaccination was none and whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD vaccine, batch number: U4491AA on left deltoid on 11 October 2012. On an unspecified date, after receiving FLUZONE HD vaccine, the patient experienced bruising from the left deltoid to the bicep, almost to the elbow and soreness to the same area. The patient had no difficulty with movement of the arm. Laboratory investigations were none and corrective treatment was not reported. At the time of this report, the patient had not recovered. Documents held by sender: None.
Per the pt he felt nauseous and had a migraine as soon as he received the vaccine.
Case number PHEH2015US016566, is an initial lspontaneous report from a pharmacist received on 21 AUG 2015. This report refers to a 28-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The reporter stated that the FLUVIRIN 2015/2016 (batch number: 15731P) was administered intramuscularly and the patient had tightened up the arm and the most of the vaccine came back out on 20 AUG 2015. No adverse event was reported.
The first thing I noticed was a lot of sinus drainage, runny nose, and a cough. Later that night my cough became much worse. I also had some chills and extreme fatigue. When my husband tested positive, I went to urgent care and had an antigen COVID-19 Test. My cough was really bad. I called the nurse practitioner and asked for PAXLOVID. They prescribed PAXLOVID. My symptoms began to improve a day later. I was still tired, but the cough and drainage were much better. I developed a bad case of diarrhea which was extremely watery and bright yellow. I used the BRAT diet and that took care of it. I have completely recovered. I am still a little tired but everything else seems to be good.
I got the vaccine on 1/15/2021 felt fine afterwards. A little sore arm Saturday morning but nothing too crazy. Starting 1/21 the site started to itch, & kept getting worse. I noticed morning of 1/22 it was welted, all red, bumpy & warm to touch. I notified the lady who gave it to me & she said I could be having an Immune reaction to it. Advised to take an allergy pill. Ended up around 1130a taking 1 Zyrtec. Welting went down, now its almost like a spotty rash, still warm to touch.
Received Influenza vaccine 10/3/03. Arm became very swollen and bruised. This lasted approx. 3 weeks. Arm is still sore and slightly discolored 5 weeks after vaccine given.
pt sent home from daycare 19NOV96 w/suspicious rash;seen in office w/dx of chicken pox & zovirax was prescribed;
Eyelids red and burning, fever and chills, coughing, vomiting, headache.
the rash is itchy but not extremely bothersome, on the patient's inner legs, top of feet, and axilla; Itchy rash; This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on 30th September 2014, subcutaneously).   On 6th November 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash and itchy rash. The patient was treated with valaciclovir (Valacyclovir). Shingrix was discontinued. On an unknown date, the outcome of the generalized rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced rash which was itchy, but not extremely bothersome and was on the patient's inner legs, top of feet, and axilla. The patient was given valcyclovir to treat the rash, but rash was ongoing at this time. The different provider instructed the patient to not to complete the series due to a rash after receiving dose 1. The previous dose was administered by a different provider, so lot and other details are unknown. The reporter consented to follow up.
WED. UPPER LEFT ARM SWELLED, BECAME HARD, RED, VERY PAINFUL. COULD NOT SLEEP. RED GRADUALLY WENT DOWN TO ELBOW. THURSDAY- SLIGHT IMPROVEMENT - CALLED PHARMACY. I ALREADY TOOK ANTIHISTAMIN & TYLENOL. HE SIAD - ICE PACK. - I AM THE THIRD ONE TO CALL WHO HAD BAD REACTION TO PNEUMONIA SHOT. SUNDAY - 4TH DAY - STILL SOME RED & YELLOW TO TOP ELBOW Sunday - Aug. 25. Woke up with slight headache, ocular crystals. Bicep - left arm - sore but not painful. Skin looking much better. Only a little yellow & slight red left. Wednesday night - when I got up to go to bathroom - I was dizzy. Thurs., Fri, & Sat. - I was sleepy & slept a lot. Sunday- up @ 7:30AM. took nap at 11AM & when I awoke, the crystals - ocular-were gone. Slight headaches. Still some exhaustion left. Why exhaustion? I thought it would be done in a couple of days & was surprised That it took so long. Thinking back, I think I should have had my family doctor check it. Pharmacist said I am Third one to get this reaction. Aug. 26, 19. - Monday. only slightly lt, red, no swelling, only slightly headachy - lt. tinney sounds in head - off & on. Arm seems pain free. I am very tired. Going now to store to fax this.
patient was having allergies; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (parent) reported a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was having allergies. The patient was scheduled to take the 2nd dose of BNT162B2 on the date of report. The reporter wanted to know what would be the recommendation for this situation. The reporter could not remember the exact date the patient received the 1st dose of BNT162B2 but said it was 3 weeks ago. The outcome of the reported event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Gave the SHINGRIX shot subcutaneously in error. Patient has experienced no ill effects thus far. Just wanted to notify of the dosing administration error.
24-48 hours after injection, patient had symptoms of vomiting, headache, vertigo, and fever of 102. He could not keep food down and drank only water. Patient had minor swelling at injection site.
Pt is a plastic surgery resident who noticed numbness and tingling in her left lower extremity following a flu shot on 10/25.  Sx progressed to involve paresthesias and abnormal sensations in both lower extremities and then the upper extremities.  She also noticed decreased coordination while at work although mentation remained sharp.  Pt denied any sports or trauma injuries, any recent travels, or any new foods.  She did note some chronic shoulder sx which were musculoskeletal in nature and related to posture and ergonomics from doing long surgeries at work.  Diagnosis was possible Guillain-Barre syndrome.  MRI was significant only for mild multi-level DJD, but there was no cord compression and no lesions noted in the brain or cord.  On 10/28, the pt was thought to have some weakness on exam along with her sensory changes.  An EMG perfomed 10/28 failed to show any evidence of a neuropathy, but it was believed that the pt's onset timing was too acute and that repeat EMG and repeat LP may have shown changes more consistent with GB syndrome.  Throughout her hospital stay, pt did endorse neuropathic changes noting paresthesias in her arms and legs which later progressed to her trunk.  Pt was discharged on 10/29 with a scheduled f/u appointment with Neurology.  Pt was improved at time of discharge although it was still not fully clear as to the cause of her neuropathic sx.  01/25/05 Discharge Summary of 10/27-10/30/2004. FINAL DX: Probable GBS Patient experienced problems with numbness and tingling in lower extremity day of flu shot.  Symptoms were progressive and she was admitted 2 days' later and treated aggressively w IVIG therapy.  Neuro consults for origional evaluation at admission and when blood patch placed.  She was successfully treated for post LP headache with a blood patch.  02/02/05 Neuro Clinic records: Post discharge office evaluation. Findings at that time showed minimal residual changes and that she was back to work, if not for the prolonged periods she had tolerated prior to the attack.
On day 6 I noticed a slightly raised red rash on my left deltoid around injection site extending slight down to my bicep. The rash was itchy and slightly warm to touch. I also had swollen nodes under my left arm and over my left clavicle. Rash persisted for over 10 days and there is still a lymph node swollen over my left clavicle.
Patient stated that after 10 minutes she started to develop tinging in the back of throat. She made healthcare provider aware after sitting for 30 minutes. Benadryl given and patient sat for 20 more minutes. Symptoms worsened with irritation down her throat and tingling into the tongue. 911 called
As soon as I got out of bed this morning, I immediately had stomach pain and and felt nauseous. I had diarrhea this morning. I just went again now just before 2 pm and it was very mushy but not pure liquid. I?ve had to lay down most of the day due to on and off stomach pains and nausea.
Having an allergic reaction on my forearms, and upper thighs.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 03:30 (Batch/Lot Number: En6206) as SINGLE DOSE for covid-19 immunisation.The Patient's Medical history were not reported.The patient's concomitant medications were not reported. The patient experienced having an allergic reaction on my forearms, and upper thighs. (drug hypersensitivity) on 05Mar2021 15:45 with outcome of not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt developed severe intermittent pain on left rib cage below breast from sternum to spine that started approx 7 days after vaccine admin. & continues off & on. No rash or skin symptoms. Had CXR by pulm dr. & it was clear.
I felt feverish the next day but only slightly and not for more than an hour or two. I had worse pain around the injection site and hand sore and swollen lymph nodes under my arm on the right side for a few days afterward.  Tested Positive for COVID-19 on 6/18/2022 I attended a Conference the previous week, I'm pretty sure I got it there.
Experienced heart racing for 2 days after each dose.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on an unknown date in 2021 and also the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 12Jul2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included allergic to cranberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included acetylsalicylic acid (ASPIRIN) and ibuprofen (MOTRIN); both for unspecified indication and unknown date. On 13Jul2021 at 13:00, the patient experienced, heart racing for 2 days after each dose. Most significant was after the second pfizer. Patient stated that she had trouble getting heart rate down. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event experienced heart racing for 2 days after each dose was recovered on an unknown date in 2021.
Pt. states she received shingles vaccine at pharmacy on 3/21/14. It was administered in her left bicep. Pt has approx. 3 x 3 area to left bicep with erythema, slight swelling, and warmth. Pt was treated with Acyclovir.
pt recvd vax 14nov, 16nov woke up w/ hot red face & purple hands;17nov arm area where inj given was red,swollen hot red,red streaked to elbow;devel hives & itching;to MD;given meds;28nov no hives,red streaked gone;color good;occas itching;
Patient says that he got severe arm pain about 4 hours after getting the vaccine, which has lead to his arm to be stiff and can barely move it. Patient also said he felt some arm pain when got injected and has never experienced that before.
Developed a lump on my neck/shoulder area that has not gone away.  Lump  sized about 3.5 inches by 1.5 inches.
Within minutes of receiving first dose of Moderna COVID-19 vaccine, patient became lightheaded and pale, developed clammy skin, and was confused. He was assisted to a supine position with his feet elevated while his vitals were checked. His symptoms rapidly resolved in this position, and he was noted to have the following vitals: P: 60; BP: 118/68; O2 Sats: 98% on room air. He remained supine for ~15 minutes and then was able to sit and ultimately stand without return of symptoms. He was monitored for 30 more minutes during which time he remained asymptomatic and was able to tolerate eating and drinking without difficulty. He was released to home with advice to seek immediate evalution for any symptoms.
p/vax pt lethargic;the following day was nauseated;fever of 103F;blurred & doubled vision;
patient received vaccine at 1315 according to chart. Patient walked to observation area around the corner. Patient sat down for a few minutes before feeling like room was swaying. He told himself to calm down and relax and read the vaccine handout. it was then wife who sat next to him noted him to be sweating and clammy and asked if he was ok. She observed his eyes rolled back and witness him having a seizure for about 30 seconds. Patient later told us he thought he went to sleep. Wife witnessed him grabbing his neck as if he couldn't breathe. Team in the observation area called out for RN. RN noted patient slouched to the left side. LVN came to patient and attempted to arouse him and rubbed his chest. Patient then woke up and didn't realize what was going on. Nurse noted patient became incontinent and assisted him to wheelchair to be observed on a gurney. Vital signs obtained and WNL. 911 called and paramedics brought patient to hospital for further monitoring. According to patient & wife, patient does not have history of seizures or any other medical conditions. Patient is not on any medications. patient denies any pain or difficulty in breathing. patient agree for paramedics to take patient to the hospital.
hematoma on injection site R thigh. Pt complain of itching and tenderness. Dr. prescribe HC 2.5%.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). The patient's past medical history included viral infection. Previously administered products included Valacyclovir (The patient received 2 courses during the previous year). On 5th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 5th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. In April 2018, the patient experienced welts. The patient was treated with BENADRYL. On 8th April 2018, the outcome of the injection site erythema and injection site pain were recovered/resolved. In April 2018, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and welts to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was unable to provide the expiration date of SHINGRIX as their system automatically default this to 1 year after the administration date. The patient received SHINGRIX in arm and on the same day developed redness, swelling and soreness at the injection site. This got better after approximately 2 days. As per the healthcare professional, by day 5 to 6 following the injection, the patient reported developing welts over the whole injection arm. The batch number of SHINGRIX was updated from VY3X4 to ZY3X4, as per sales data sheet. This case has been linked with case US2018063410, reported by same reporter.
I had soreness around my arm of injection site for about 3  days.    I also wanted to let you all know that I had a sore throat that started the day after my first dose.  Sore throat started off as mild but later got worse by the 2nd day.  I also experienced a mild grade fever, headaches, and chills which went away in a couple of days.  HOWEVER, today (1-14-2021) I decided to rule out the possibility of me having COVID.  So I got tested for covid and I was tested positive via the RT-PCR at a local urgent care facility.    So with that being said I am not quite sure if the sore throat, mild grade fever, headaches, and chills were part because of the vaccine dose (first dose)  or it could have been from  experiencing covid symptoms.    Treatment I used were drinking LOTS of water, Tylenolol and Advil, Cephacol lozenges,  and sleep.
Light-headed; dizzy spells (3-4 x during day continuing through following day.