chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial pregnancy report received from a healthcare professional on 21 January 2014. A 38-year-old female patient, had received an intradermal first dose of FLUZONE ID (batch number: UT4722AA, expiry date 10 April 2014, anatomical site of vaccination was not reported) on 20 January 2014. The patient had neither allergies nor any medical history. The patient received vaccine during pregnancy. The patients last menstrual period date was not reported and the estimated date of delivery is 01 April 2014. As of this report, the patient had not experienced any adverse events. Laboratory investigations were not reported. Follow-up pregnancy report received from a healthcare professional on 29 July 2014. It was reported that patient was vaccinated at private hospital and vaccine purchased with private fund. Mother's health status (relevant ongoing illness) was reported as healthy. No family history of congenital abnormality was reported. Pregnancy information: Estimated date of delivery was reported as 12 April 2014. No previous pregnancy was reported. Route of vaccination was reported as intradermal right deltoid (arm). Mother did not receive any drug during pregnancy. It was reported that mother did not experience any relevant non serious adverse events. Pregnancy outcome was reported as healthy baby girl without any pregnancy complications. Child outcome: (healthy baby girl born). Apgar score was reported as '4, 5 and 8' in 10 minutes, week of gestation was reported as 42. Height of the baby child was reported as 150 inches. Weight: 2.96 kg.
nauseous; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at 10:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL9262. Medical history included Heart problem and a block for migraines, Supplementation therapy, Thyroid problem, Nervousness. Concomitant medications included amlodipine for Heart problem and a block for migraines, levothyroxine sodium (LEVOTHYROXINE) for Thyroid problem, lorazepam for nervousness, colecalciferol (VITAMIN D); all drugs were ongoing. On 10Feb2021, the patient experienced nausea. The patient did not recover from the event. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211507 same reporter/drug/event, different patient
2nd day p/vax pt devel diffuse facial, periorbital, perioral edema & rash-improved w/DPH but still somewhat evident when finally seen @ clinic 5 days p/vax;rash on face;swollen;swelling of cheeks w/papular, diffuse erythematous rash;
From the parent: "She broke out in a rash, her muscles were still sore from the injection even though she has been moving her arm. Excessive tiredness more than her normal routine. We were given a steroid medication to help."
Significant pain and inflammation in the left should joint, with pain radiating down the arm. Pain the arm and feeling of swelling and inflammation has continued, with pain the in left wrist and hand. I have developed trigger finger in the left index finger.
On March 1, 2021 I woke up very lethargic and tired - just want to sleep.
Syncope, sweating, "feeling out of it"and that he was going to pass out. Had to lie on the floor for at least 20 minutes and even then he feel bad when he would get up, all of the same symptoms.
Pt recvd 3 doses of Engerix-B & was found to have a neg titer; Pt recvd a 4th dose of Engerix-B 10MAR92 & now has a pos titer;
nausea; cold sweats; fatigue; flu like symptoms; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 13-Feb-2021, the patient experienced FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms) and COLD SWEAT (cold sweats). On an unknown date, the patient experienced NAUSEA (nausea). On 11-Jan-2021, CHILLS (chills) and HEADACHE (headache) had resolved. On 18-Feb-2021, FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (nausea) and COLD SWEAT (cold sweats) had resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.
24 hours after administration patient noticed redness, swelling and warmth. Large bump "half-dollar size", lasted for 1 week.
Redness, erythema encompassing (R) bicep only. No FV, no wheeze/stridor/dyspnea.
Vaccines given at approximately 12:39pm, shortly thereafter, patient became listless and diaphoretic. Mom immediately notified MA who in turn notified RN. Patient was returned to exam table, legs elevated, vitals taken, oxygen administered. MD at bedside monitoring treatment. Eventually, she was sat up, given juice and crackers. She was discharged at 1:10pm.
Information has been received from a physician concerning a 19 year old female who on 20-AUG-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM (lot # 659184/0843X).  The patient was given a TB test at the same visit that she received the vaccine.  On 20-AUG-2008 the patient experienced lockjaw, lightheadedness and cramping of her right leg within twenty minutes after vaccination.  The patient was seen at the emergency room where she was given intravenous VALIUM and intramuscular TORADOL.  The patient recovered from lockjaw, lightheadedness and cramping of her right leg on 20-AUG-2008.  Upon internal review, the patient's events were determined to be other important medical event (IV and IM treatment required).  Additional information has been requested.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
fatigue (extreme, could barely keep eyes open), headache, painful deep breaths, heart racing, fever over night with night sweats, body aches/ joint pain, hot/cold flashes,  loss of appetite- all happened with in 2/2 to 2/3.  Symptoms began to resolve on 2/4
Patient received the J&J vaccine in her L arm at 1:11 pm. Patient was sitting in the observation area and started to complain of feeling warm and dizzy, began at 1:19 pm. Vital signs taken at 1:22 pm, BP 108/66, HR 50, T 97.0, RR 16, O2 99% RA. Patient stated she felt sweaty, cool/clammy and dizzy. She appeared pale and diaphoretic. Patient ambulated indeendently into the seccluded first aid room. Patient lied down onto the cot. Vital signs taken again at 1:28 pm, BP 102/58, HR 54, RR 15, O2 98% RA. Patient said her baseline BP was "normal" but couldn't remember the numbers. Legs elevated, patient stated she was starting to feel better. Denied dizziness or nausea. At 1:38 HR was 43, 911 called at that time.
flu like sx wk of 17NOV96 & again wk of 8DEC96;pain in neck & shoulders 23DEC96;weakness 24DEC96;collapsed in floor 26DEC96;hosp 27DEC97 transferred to rehab ctr 31JAN97;totally paralyzed staph pneumonia;T107.4;
On Tuesday morning, I woke up with a sore throat and sinus congestion and pressure. I went to a local clinic. They did a rapid COVID-19 test and a PCR COVID-19 test. They both came back negative. That day, I felt worse and worse as the day progressed. I had more coughing and more congestion. On Wednesday, I retested with an at home COVID-19 test. It was positive. It was late in the day so I couldn't call a doctor to see if we could get the antiviral. I called the doctor on Thursday morning and had a telehealth visit with him. He prescribed an antiviral. We had to drive 45 miles to get it. It was prescribed to be taken every 12 hours for 5 days with four pills total. I started feeling so ill, I started my first dose at 6pm that night. My temperature got up to about 101 degrees. I had a persistent barking cough that made my diaphragm muscles sore. I had a dull headache and sinus pain. I also had chills periodically. By the next day, after the second dose, I noticed I wasn't feeling as sick, but I was still very fatigued. Each day after, I felt better. My fever broke, and the cough decreased. By day 3, the cough was minimal. I was up moving around and doing chores. I had some stomach upset from the antiviral. It was mostly indigestion. I also had a little bit of loose bowel movements. As of yesterday, I felt well enough to clean my kitchen, but I had to rest to get my energy back. I took another COVID-19 test today and it was negative. I still have some sinus pressure and feel more tired than normal.
Right eye / tenderness; Right eye rash; Flashers in eye / sees flashes of light and dark; Red rash in a band around his head; Pins and needles feeling on left lower ribcage, feels like electric shock bolt of pain; Ribcage is red but no rash; lower left ribcage he has touch sensitivity like 1000 needles; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Occurred 13-14 years ago from the date of reporting) and pins and needles (experienced 1 month before injection date, 2-4 yearly episodes).   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 1 week after receiving Shingrix, the patient experienced red rash, pins and needles, erythema and touch sensitivity increased. On 21st September 2020, the patient experienced eye tenderness, rash and flashing lights. On an unknown date, the outcome of the red rash, pins and needles, erythema, touch sensitivity increased, eye tenderness, rash and flashing lights were unknown.   It was unknown if the reporter considered the red rash, pins and needles, erythema, touch sensitivity increased, eye tenderness, rash and flashing lights to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have lot number and expiry date. 1 week after Shingrix the patient developed a red rash in a band around his head.  He had pins and needles feeling on left lower ribcage.  His ribcage was red but no rash.  On lower left ribcage the patient had touch sensitivity like 1000 needles, it felt like electric shock bolt of pain that comes and goes quickly. The patient also experienced right eye rash and tenderness.  He had flashers in eye where he seen flashes of light and dark it goes on and off for 15-20 minutes then goes away.  Eye flashes had been lasted for 2 days. The reporter consented to follow up.
Instant hives and itchy prickly feeling going on 24 hours. Is managed with Benedryl and Claritin
Patient states that her arm started to become stiff and hot at the injection site and complained of inability to pick up anything without severe pain. Patient presented to the pharmacy with symptoms 2 days after receiving the injection.
More red dots from the left elbow to the wrist, looked like blood spots under the arm and skin; Symptoms worsened/More red dots from the left elbow to the wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (More red dots from the left elbow to the wrist, looked like blood spots under the arm and skin) and RASH (Symptoms worsened/More red dots from the left elbow to the wrist) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 091D21A, 013M20A and 012L20A) for COVID-19 vaccination.     It was reported that the patient had never been diagnosed or tested positive for COVID-19. The patient did not have any allergies to medications, food and other products. No other vaccines were given to the patient within 1 month prior to administration of Moderna COVID-19 vaccine.  Concurrent medical conditions included High cholesterol (No change in status), Immunocompromised (patient is immunocompromised due to white blood count lower than average) and White blood cell count low (patient is immunocompromised due to white blood count lower than average). Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 09-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced RASH MACULAR (More red dots from the left elbow to the wrist, looked like blood spots under the arm and skin) and RASH (Symptoms worsened/More red dots from the left elbow to the wrist). At the time of the report, RASH MACULAR (More red dots from the left elbow to the wrist, looked like blood spots under the arm and skin) and RASH (Symptoms worsened/More red dots from the left elbow to the wrist) had not resolved.            The patient experienced the adverse events a couple of days later in Apr-2022 after receiving the second booster shot of Moderna vaccine (unable to capture event onset date of Apr-2022 in events tab due to hard validation). The patient received the second booster shot on 09-Apr-2022.  The reporter stated that the red spots were not itchy and not raised on the skin. It was also reported that the patient did not have any reactions to the first and second Moderna primary series doses but the reporter believed that the patient had a reaction to the Moderna booster doses.  The patient had not experienced a similar event in the past.  The reporter believed that the patient had a reaction to the Moderna booster doses.  Concomitant medications also included thyroid medication and hormone replacement therapy.  No treatment information was provided.   This case was linked to MOD-2022-538941 (Patient Link).
Dizziness, Myalgia, Arthralgia, NauseaVomiting, chills, and feeling foggy mentaly Narrative:  Other Relevant History:
1-2 days s/p vaccines administered, loose stools 6/8 x day and have persisted through present. Used to have BM Q6 x BID.
Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Feeling of passing out, in and out of consciousness, general weakness, sweats, weakness in breathing-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe
Severe left arm pain begining 3 days after 1st dose of vaccine Narrative:  ED visit after 1st dose of vaccine on 2/4
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2014, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. On 08-FEB-2017, the patient passed away. The cause of death and autopsy results were unknown. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Approximately 48 hours after receiving the booster vaccine, I developed a small "rash"/skin discoloration on my left middle and index fingers, and thumb. It did not itch or burn or feel sensitive to the touch, but was highly visible. It looked like a bruise, with red/purple discoloration. By the 4th day, it had completely disappeared.
Her pressure was high 200/78; She felt her throat tightening/Hard to swallow; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Her pressure was high 200/78), THROAT TIGHTNESS (She felt her throat tightening/Hard to swallow) and MALAISE (not feeling well) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (to erythromycin), Hypertension, Haemoglobin low and Drug allergy (to Compazine). Concomitant products included HYDROCHLOROTHIAZIDE, ROSUVASTATIN, ATENOLOL, TELMISARTAN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERTENSION (Her pressure was high 200/78), THROAT TIGHTNESS (She felt her throat tightening/Hard to swallow) and MALAISE (not feeling well). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jan-2021 for Adverse event following immunisation, at a dose of 25 milligram. At the time of the report, HYPERTENSION (Her pressure was high 200/78), THROAT TIGHTNESS (She felt her throat tightening/Hard to swallow) and MALAISE (not feeling well) outcome was unknown. they gave her an injection of Benadryl 25 mg. Took pressure again and it was still high. Ambulance stated she should go to ER. She went to the ER, felt better and went home. Pressure is still high    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood pressure measurement: 200/78 High. On an unknown date, Clostridium test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I received the shot at 11:25AM. At around 7:30PM, I felt the symptoms of the common cold: head ache, weakness, body aches, chills. By night time around 10PM, I had fever of 100F. The next day, Saturday, April 10th, I got my period in the morning. I had migraine and felt weak all day. Felt fine by 6PM. On Sunday, April 11th, I woke up feeling good but then around 12PM I got a heavy nosebleed.
Pain and burning in waist followed by bruising around waist and back. Bruises are fairly evenly spaced along waist and left flank to back.
Pt recvd vax & inject site became red & swollen & devel fatigue; no treatment given;
This spontaneous report received from a patient via other company (RA) concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1). On an unspecified date, the patient received second dose with Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered for prophylactic vaccination. The patient received third dose booster with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, 1 total administered on DEC-2021 for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose and frequency were not reported from an unspecified date to 2021 for ankylosing spondylitis. No concomitant medications were reported.  On DEC-2021, the patient experienced vaccination site pain, and arm hurt for a week (dose number in series 2). On FEB-2022, the patient experienced right knee surgery (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from vaccination site pain and arm hurt for a week, and the outcome of right knee surgery, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220413065- Covid-19 vaccine ad26.cov2.s-right knee surgery. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.
Pediatric participants were vaccinated with a dose that was not prepared with diluent. The vial prepared was not prepared with 1.3 mL with diluent as per the CDC.   No symptoms were reported during the time of observation.
Pt called in to pharmacy ~2 hrs after dose at 11:29am to report she had, upon injection, immediately felt off. She did not mention it at the time of injection. During her call, she informed pharmacy she experienced a head rush type of sensation followed by ear ringing that eventually settled into a pressure in her ears. Pt said she continued to feel the pressure 2 hrs later. Ear symptoms accompanied by mild confusion/head cold like symptoms.