chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not been feeling well; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via specialty pharmacy.  This case involves a 75 year old female patient who was not feeling well (malaise), after she received vaccine INFLUENZA VACCINE and was being treated with TREPROSTINIL SODIUM.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Medical history included pulmonary arterial hypertension, which was ongoing at the time of report.  Concomitant medications included MACITENTAN (OPSUMIT) and SILDENAFIL CITRATE (REVATIO).  On 13-Dec-2018, the patient started taking  of TREPROSTINIL SODIUM (lot - 2101813, expiry date: 30-Apr-2021, strength: 0.6 mg/ml) (current dose reported as 60 to 120 micrograms, 10-20 breaths four times a day (QID)), for primary pulmonary arterial hypertension via inhalation (IH) route.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiration date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced non-serious event of not feeling well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE and TREPROSTINIL SODIUM. The patient wondered if her unspecified symptoms were related.  No laboratory data was provided.  Action taken with TREPROSTINIL SODIUM (TREPROSTINIL SODIUM) was not reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The reporter did not provide causality of event malaise with suspects.  There will be no information available for lot number.
Pt. had severe muscle pain on his right arm starting the day after his vaccination up to 8 weeks. He stated that he still has pain upon pressure, but it's getting better
Tinnitus. Ringing in ears.  I have been to the doctor and have no hearing loss or other health issues
Nausea; My hand was purple-ish and tingling; My hand was purple-ish and tingling; lymph's were so swollen; hand was basically unusable; Sick; Weak; Extremely sore arm; Chills; Cold sweat; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 33-years-old non-pregnant female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date not reported), via an unspecified route of administration in Arm Right on 25Jan2021 15:00 (at age of 33-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported and no allergies to medications, food, or other products. The patients concomitant medications were not reported. It was reported that patient was not pregnant at the time of vaccination. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient diagnosed with COVID-19. It was reported that on 25Jan2021 at 15:00 extremely sore arm, unable to use for 5-7 days. The first 24 hours patient had chills even with 3 blankets on. She shivered and started to cold sweat into the next day. Nau-sea came and went for 72 hours. The weirdest part was her arm and hand. Her hand was purpleish and tingling for 6 days. Patient was told to try to move it and maybe her lymph's were so swollen they were pressing on a nerve. However her hand was basically unusable the entire week. Patient was so sick and weak for the entire week. Patient did not received any treatment for ad-verse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered with sequelae.  Information on the lot/batch number has been requested.
Sore arm on the afternoon of May 11. Pain continued to get worse until the evening of May 15 when sores/blisters started to appear.
There were no, adverse events. Patient who is a minor (17yrs and 1month old)  recieved a Moderna booster vaccine.
No additional AE reported; doses of ROTATEQ, GARDASIL 9 and VARIVAX were administered following excursion; This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender.  Information regarding concurrent conditions, medical history and concomitant medications was not reported.  On 15-NOV-2021, the patients were vaccinated with an unspecified number of doses of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1821247, expiration 23-JUL-2022 and lot # 1707471, expiration date 21-JUL-2022) orally (dose and frequency not reported), varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U016065, expiration date 20-MAY-2023) (dose, frequency and route not reported) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # T029523, expiration date 13-MAR-2023 and lot # T039466, expiration date 20-MAY-2023) (dose, frequency and route not reported), all administered for prophylaxis.  The refrigerated products were stored at 29.1 degrees Celsius (C) for 8 hours and frozen products were stored at 25.5 C for 8 hours (Product storage error). It was not specified which products were stored at which temperature and the presence of a digital data logger was not reported. No additional adverse events (AEs) were reported.
Patient received ZOSTAVAX shot on 01/09/2009.  Five days later, on January 14, 2009 she has noticed a spreading rash at the sight of injection.  She reports is is not bothersome, just concerning because it seems to be spreading.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. It was reported that in approximately in 2013, multiple unspecified patients received doses of improperly stored VARIVAX (dose, route and lot number not reported). The reporter stated that the temperature excursion for the vaccines above occurred on an unspecified date in 2013. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 5JUN96 & became pregnant;pt may exp an adverse event;No further details were provided;
Fever 102.5, aches, stomach upset, nasal, trouble breathing, headache, chills.
States h/a started about 1 hr p/receiving vax (1545) while working dizziness started about 1600; states h/a & dizziness cont @ this time;
p/vax pt started getting rash on body more on rt shoulder than lt & on back & chest;rash is all over body 6/10/99;rash is like tiny pimples;
Pt developed pallor and jerky movements of arms and lower extremities approximately 1 min. after vaccines administration. No vomits.
Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medications was reported.   Reporter did not allow further contact
The evening 02/25/2023, I was having lethargy, my throat hurt and I was coughing. I took a COVID-19 Home Test, and the result was positive immediately.  I went to the clinic, and they tested me again and the result was positive. I quarantined from 02/25/2023 - 03/02/2023, the day we finished the trip. The night of 02/28/2023, my eyes were like tearing, I got Kleenex to wipe my right eye and there was a pale green of gunk on it and on the other eye there were yellow gunk coming out of my eyes. It was thick gunk. All of a sudden my eyes started draining and at the same time the lower part of my face, underneath my nose, my lips was swollen and it swelled up like a balloon right in front of my eyes. I went to the clinic and the doctor prescribed me an antibiotics  and 2 IV's. IV Cetirizine and IV Loratadine. The doctor told me it was a reaction to COVID-19. The next day my eyes were no longer swollen and there wasn't more green and yellow gunk coming out.  I recovered. I see well now. My eyes don't bother me. When I returned back to from the trip, I was so weak and could not walk.  My doctor, on 03/09/2023, diagnosed me with bronchitis and sinusitis and she prescribed antibiotics, and an inhaler, Albuterol. I lost 10 pounds and was wiped out for the whole month of March 2023 and mostly slept, I had a cough. I laid low most of April and returned to work for the first time on 04/24/2023.
W/i and hour of injection: Injection site soreness 10 hours post injection: chills, joint aches 15 hours post injection: headache, 101.4 degrees F fever
Extremely sore arm x 4 days. Exhaustion, muscle aches, lethargy, neck pain, serious headache for 7 days. Continued lethargy and pain and headache for 16 days.
Information has been received from an office manager concerning a 73 year old female pt with no allergies and no past medical hx who on 03NOV2003 was vaccinated in the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included alendronate sodium and Celebrex. On 04NOV2003, the pt presented to the medical office because her left arm had swelled from her elbow to her shoulder. The patient  also had a large 3x4 inch dark red area also described as a red spot, surrounded by a dark pink area on her arm. The pt was treated by the physician with Benadryl and Keflex. No lab tests were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. The reporter requested replacement for the vaccine, but was unable to provide the lot number. Additional information has been requested.
Whole upper arm is red. Some part of the arm blew up like a big bubble and it moves down below elbow.
The excursion expiration by Pfizer was 7 days, but goes by the original expiration of 5 days once refrigerated from freezer. This was under 7 days.
pt exp swelling & stiffness in lt arm;initially the swelling was the size of a quarter w/in 24hr the swelling had significantly inc;pt exp extreme difficulty in moving arm;pt had a sl fever;swelling dissipated approx 7 days post vax;
About 8 days after my vaccine, I noticed the injection site became tender to the touch (after the initial soreness had been gone) and a red, circular red patch (sort of like a rash) developed on my arm. It is small, only about 2 inches in an uneven circle. It's not raised nor does it itch or cause any difficulty moving my arm.
Patient engine was powered down; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient engine was powered down), PYREXIA (Fever) and FATIGUE (Fatigue) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2022, the patient experienced ASTHENIA (Patient engine was powered down), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Patient engine was powered down), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication information was provided.  It was reported that patient did not identified any PQC, no additional AEs and no additional information.  No treatment medication were provided.   Reporter did not allow further contact
8/24/06 Mom came in. She stated that the child had a reaction to immunizations on 6/21/06. Mom stated child rt leg was very red and swollen (double in size) from thigh to knee. Mom stated that she called Dr and stated Dr told her it was probably reaction from MMR given. Dr advised to give Motrin and apply warm packs to area. Mom stated leg was better in 2 days. Mom stated she forgot to call our office to report reaction.
Within 20 hours he developed a lump where shot given.  Headache, chills--down spine and across shoulders.  Neck stiff.  Extreme pain.  Within 2 days had an open sore with extreme redness, radiating around arm.  The next day redness had spread even after starting antibiotics.
Patient received Pfizer COVID vaccine at 7:23am. Reported headache at 7:35am, at 7:49am reported chest tightness and itching in throat. Benadryl administered at 7:53am. V/S 99%, 125/84, 85, 17, 36.3. Lungs clear all lobes. At 8:00 am pt reports relief of symptoms.
Moderate pain at injection site started about 3 hours after injection and is still present the next day, though it has become mild and appears to be resolving.
Lungs filled up - CT scan looked like glass - similar to COVID19 patients  Had multiple COVID 19 tests all negative o2 levels very low in hospital for 12 nights to stablezize
August 9, 4:30 am woke up due to chest pain. Took him to er and ekg was abnormal. Scheduled appointment for following month with cardiologist and ekg showed abnormal right branch blockage. ECG was also done and it showed everything was ok. A few months later (November), he had another episode?woke up with chest pain. This time we scheduled stress test with cardiologist. Result was everything normal/fine. Today, February 11, 2022, he woke up at 4:30 am with chest pain, again. Every time this happens, pain is in his left side (heart area). Pain increases when laying down, breathing out, or moving his arms as if hugging himself. Pain subsides when sitting up. It also helps alleviate pain if his left arm is lifted above his head while sitting up.  No treatments prescribed since they found nothing.
Information has been received from a consumer concerning her 16 year old daughter with asthma, allergy to animal and grass who on 05-OCT-2007 was vaccinated with a first dose of GARDASIL (lot# 658488/0930U) IM in the right arm. There was no concomitant medication. On 05-OCT-2007 the patient experienced pain in the injection site "right after administration." On 06-OCT-2007 the patient experienced pain in her stomach, had headache, nausea and breasts were hurting. Unspecified medical attention was sought. On an unspecified date the patient has a "pap smear" (results not reported). At the time of report, the patient had not recovered. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. Follow-up information was received from the physician's office. The patient had no illness at the time of vaccination. Concomitant therapy on 05-OCT-2007 also included BOOSTRIX (lot# AC52B0240A) IM in the left arm. The patient recovered from headache and nausea on an unspecified date approximately in a week. Additional information is not expected.
Tightness in chest , Hives, weakness,  required visit to E.R. Given IV Benadryl Pepcid, prednisone
Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing  a cloud-like blurry vision, intermittently, during the day.
I started to experience symptoms about a month after receiving the Moderna Bivalent. I started to have a sore throat. I tested 48 hours my sore throat started and it was negative. Another 48 hours later, I tested positive. I tested again 2 days later and it was negative again. I took TYLENOL once and I drank Gatorade straight for 2 days. I never had a fever, or many other symptoms, only fatigue.
Large oval redness/soreness around vaccine site, about 11cm diameter.  Generalized shoulder aching and low grade fever.
Patient  has a fear of needles. After her injection, she tried to stand up to tell me she does not feel good but fainted before getting to the counter. She hit her head at some point.  We gave her some water and called the paramedics.  After checking her out  she was instructed by the paramedics to go to hospital.  She went to the student health center and given information regarding head injury.  She later return to collect her Vaccine record card.
Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------- R57.1 HYPOVOLEMIC SHOCK 6/21/2021 HYPOVOLEMIC SHOCK
p/vax pt has a dime sized irregular shaped dimple @ inj site c/w fat atrophy;
Hair loss after receiving the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair loss after receiving the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported. 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss after receiving the Moderna vaccine). At the time of the report, ALOPECIA (Hair loss after receiving the Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.  This case was linked to US-MODERNATX, INC.-MOD-2022-670176, US-MODERNATX, INC.-MOD-2022-670184 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670176:Female case 1 US-MODERNATX, INC.-MOD-2022-670184:cross link case MOD22-028969 (2 female patient)
(R) thigh below imm site about 1 cm well demarcated borders, no warmth, + wheal, +flare reaction evident w/ changing hot circumferential.
severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 15-Mar-2021, PAIN IN EXTREMITY (severe arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine information is provided by the reporter   This case was linked to MOD-2021-073934 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document is received on 17-JUN-2021 and it doesn't have any new information
Muscle pain, fatigue, headache, fever, shivering, diarrhea, starting mid-afternoon after I received the injection, continued for approximately 36 hours.
pt returned to pharmacy with a red, hard, raised area on arm that he stated was where injection was given. pt has spot excised and it was found to be squamous cell carcinoma.
Patient developed profound sensorineural hearing loss and mild vertigo in the left ear one week after vaccination.  This has persisted until today.  MRI showed no tumor or stroke. 1/7/08-records received-office visit 12/17/07-developed acute onset of dizziness and vertigo/room spinning as well as hearing deficit that was worse on left and slightly decreased on right. Nasal congestion since onset of symptoms. Impression: labyrinthitis. Office visit 12/28/07-Left ear hearing loss. Vertigo symptoms intermittently. Impression:sudden sensory neural hearing loss with very little improvement. Per 60 day follow up: Permanent hearing loss. 1/15/2010 I don't think her event was related. She had sudden sensorinearal hearing loss.
I felt tingling in my fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (I felt tingling in my fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included LOSARTAN for Blood pressure, LOVASTATIN for Cholesterol.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PARAESTHESIA (I felt tingling in my fingers). At the time of the report, PARAESTHESIA (I felt tingling in my fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-242471 (Patient Link).
Patient received third dose of Maderna vaccine.  14 days after hives appeared to body.
The patient made an appointment with the pharmacy to receive a Td of Tdap vaccine following  the possibility of a recent exposure to tetanus. The patient also made an appointment to receive a fourth dose of the Pfizer Covid booster. They stated they recently had surgery on their right arm and wanted both vaccines in their left arm. The Td vaccine was administered first, followed by the Pfizer. The patient waited in the pharmacy for 15 minutes following the Pfizer vaccine. The documentation was filled out and it was discovered that the Td vaccine that was administered expired 05.15.22. The manufacturer was contacted and they stated the patient should be revaccinated.  The patient was notified of the mistake and made an appointment to be revaccinated on 06.30.22.
Developed itching L forearm Friday 3/12, rash developed by next day and was at it's worst Monday 3/15.  Rash over neck, face, trunk, arms, abdomen, back.  Rash dark pink, diffuse.
Drastic change in personality for 2 weeks following immunization.  High pitched screaming, no appetite, not easily consolable.
Three days (Thursday) after the 2nd vaccine a rash started around my waistline.  Friday the rash spread a little more around my waist.  Saturday it was also down my arms and top parts of my legs.  Sunday it spread to my eyelids, neck, upper chest, and ears with swelling and intense itching and burning.  Monday I saw the dermatologist who thought it was an airborne allergic reaction and prescribed creams and over the counter meds (pepcid and Zyrtec).  Rash/ hives covered nearly my whole body on Monday, Tuesday, Wednesday, and Thursday with no change.  Some welps, some hives,, nonstop itching... Friday it started to look and feel a little better and the dermatologist ordered stronger cream and prescription benedryl.  Today is Saturday and the first day I really think it is healing and not as itchy.
Pt. given flu shot at approx. 2:55pm-returned about 3pm complaining of tightness & difficulty breathing.
This spontaneous report as received from a healthcare worker refers to an unspecified patient of unknown demographics. On 02-MAY-2013, the patient was vaccinated with GARDASIL dose 1. On 29-OCT-2013, the patient was vaccinated with GARDASIL dose 2. No adverse effect was reported. Additional information has been requested.