chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report was received from pharmaceuticals and was assigned manufacturer report number A201200985 concerning an approximately 74 year old female patient with paroxysmal nocturnal haemoglobinuria who on an unspecified date was vaccinated with a dose of pneumococcal vaccine, polyval, (Lot #, dose and route not reported). Secondary suspect therapies included SOLIRIS 300 mg, infusion 10 mg/ml IV. Concomitant medications were not reported. On approximately 03-MAY-2012, two weeks prior to reporting, the patient was hospitalized for left lower lobe pneumonia. On 08-MAY-2012, the patient missed her SOLIRIS infusion. On 12-MAY-2012, the patient was discharged from the hospital. Treatment and outcome were not reported. Approximately in May 2012, the patient developed an infection in the arm that the vaccination was given, blockage in her stomach and pneumonia in her right lung. On 16-MAY-2012, the patient was readmitted to the hospital with the arm infection, blockage in her stomach, and pneumonia in her right lung. She was having nothing by mouth (NPO), and was treated with IV hydration and unspecified antibiotics. It was noted that SOLIRIS therapy was held by the physician until the infection resolved. At the time of the report, the patient outcome was unknown. No further information is available.
Swollen, Red area appeared 1.5 days after injection. Itchy, warm to touch, painful inside and on skin. About 3 inches in diameter. Getting larger each day.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Pt is s/p L mastectomy over 15 years ago and had been advised that she was not to receive any injections in the L arm.  Vaccine was administered into L arm.   Pt notified her physician.  Per physician, no  further follow up was recommended.
Initial information received from a healthcare professional on 09 July 2014. A 29-year-old female patient whose medical history and concomitant medications were not reported had received first intramuscular dose of ADACEL (Lot number C4543AA, expiration date was not reported) on 09 July 2014. It was reported the patient had vaccine exposure during pregnancy with no adverse event. The patient's estimated date of delivery was on 01 August 2014. Documents held by sender: none.
Approximately 5 hours after receiving vaccine for H1N1, patient experienced dizziness, light headedness. Advised rest, fluids, tylenol as directed prn and Immediate care center if needed.
Child was to receive 7 Immunizations plus PPD and fainted after #6. Was placed in shock position. BP normal, pulse and resp normal. rested and felt better after about 30 minutes. Went home. F/U next day, was doing well.
Patient was given her second dose of vaccine in her left arm around 2:10 pm. I had her switch chairs with her boyfriend and administered his second shot in his left arm as well. Just after putting the bandaid on her boyfriends arm at about 2:13 pm, the patient stated that she felt like she was going to faint. The pharmacist stood next to her while the patient was sitting and put her arm around her back. At that point within seconds the patient lost consciousness and her eyes rolled to the back of her head. Pharmacist tried to awaken the patient but there was no response and within another few seconds are entire body started to stiffen arms and legs. Laid patient down on the floor and after still not being able to arouse patient checked for a pulse. After unable to find pulse pharmacist alerted others to call 911 and get an AED. Started compressions for about 30 seconds. Patient came to and we sat her up. Patient still very drowsy but awake and responsive. EMS arrived and checked her blood pressure, was 90/50.
Became very ill; Chills; Headache; Nausea; Body aches; Lethargic/did not get out of bed; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 09:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08May2021 at 19:00, within 10 hours after taking the second dose of the vaccine, the patient became very ill. The patient experienced chills, headache, nausea, body aches, lethargic, loss of appetite and did not get out of bed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events became very ill, chills, headache, nausea, body aches, lethargic, loss of appetite and did not get out of bed was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
two days after first dose she got her menstrual cycle; patient  never experienced cramps in her life, it was just weird.; heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (two days after first dose she got her menstrual cycle), DYSMENORRHOEA (patient  never experienced cramps in her life, it was just weird.) and HEAVY MENSTRUAL BLEEDING (heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Overweight (overweight triggers her abnormal menstrual cycle), Anxiety and Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ETHINYLESTRADIOL, LEVONORGESTREL (LEVONORGESTREL + ETINILESTRADIOL) and VITAMIN D NOS for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow). On an unknown date, the patient experienced MENSTRUAL DISORDER (two days after first dose she got her menstrual cycle) and DYSMENORRHOEA (patient  never experienced cramps in her life, it was just weird.). At the time of the report, MENSTRUAL DISORDER (two days after first dose she got her menstrual cycle), DYSMENORRHOEA (patient  never experienced cramps in her life, it was just weird.) and HEAVY MENSTRUAL BLEEDING (heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was birth control pills for Continuous blood  flow.
Feeling discomfortable at the injection site; Upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 26Feb2021 12:00 (Lot number: EN6203) at the age of 58 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (First dose, Time: 12 pm, Anatomical site: left upper arm, Route: Intramuscular, Lot no. : EL9262, Expiry date: 30Jun2021), administration date: 05Feb2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Feeling discomfortable at the injection site", "Headache". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Feeling discomfortable at the injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Feb2021, outcome "recovered" (27Feb2021), described as "Upset stomach". Therapeutic measures were not taken as a result of vaccination site discomfort, abdominal discomfort.  Additional information: The events did not result to an admission to the hospital.  No follow-up attempts are possible. No further information is expected.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 13-DEC-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001821: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Swelling occurred particularly in my  extremities but very bad I?m my legs.  Dissipated after about two weeks. Was several pounds of water gain I believe. Also had a headache that was pretty intense a couple of days.
Baby cried unconsolably for 45 minutes. Would not nurse, swallow medication administered, or calm.  By 6:42 pm she nursed and swallowed the dose of infant Tylenol.
Pt recvd vax & exp fatigue, strange taste in mouth & achy pain in spine & back of neck; the day p/inject exp severe h/a;
pt recv vax 28DEC82 & 4JAN83 t103 & dx URI;unresponsive;CT scan showed subarachnoid hemorrhage;pt comatose;lt ocular deviation;sz activity;lt quad cerebral hemisphere appeared edematous;intracranial pressure;encephalitis;psychomotor retard
This spontaneous report was received from a Registered Nurse and refers to a 1 year old patient of an unknown gender. The patient's medical history, concurrent conditions or drug reactions were not reported. On 01-FEB-2016 the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneous in the leg, lot # L023112; expiration date 24-DEC-2016, concomitantly with the first dose of VARIVAX (Merck) 0.5 ml, subcutaneous in the other leg, lot # L035124; expiration date 14-SEP-2017. Concomitant therapies were not provided. No adverse effect was reported. Product quality complaint was not filed. Additional information has been requested.
After a week of receiving the 2nd shot i started having muscle aches and headaches. The headaches would not go away withmy regular prescription for migraines so I went to the emergency room at Medical Center and they gave me a prescrition and after three days the headache was gone.
Pt presented to the ED with right-sided facial drooping and was diagnosed with Ball's Palsy. Pt was prescribed prednisone in the ED. Evaluated today at our office and was prescribed valtrex. Currently experiencing right eye dryness and irritation.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    Concomitant product was not provided. Treatment information was not provided.  Patient received half dose.  On 04-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.
Nausea; now she cant move her arm; arm is in pain at the injection site; Tiredness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date: Unspecified), via an unspecified route of administration, in left upper arm on 02Feb2021 at 13:00 (at the age of 43-years-old) as 1 ST DOSE, SINGLE DOSE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had past medication doxycycline for acne (last 2 weeks), she has been taking for the past 3 months, the dose was decreased. She was on 135mg and 2 weeks ago she went to 50mg. On 02Feb2021, the patient had experienced tiredness started yesterday at night and has gotten better today and arm is in pain at the injection site. The patient informed that her arm is in pain at the injection site and this started yesterday. It started at 13:00 when she got the shot and during the night it was getting worse and cannot move her arm. On 03Feb2021, the patient experienced nausea started this morning when she woke up. The patient did not received treatment for the events. The outcome of the events tiredness and nausea was recovering while the outcome of the event arm is in pain at the injection site was not recovered. The outcome of the event now she cannot move her arm was unknown.  Follow-up attempts are completed. No further information is expected.
Fever, sweating, high level headache/migraine, vomiting, nausea, diarrhea
Reports she got a headache and flushed face one hour after receiving Intranasal H1N1 vaccine and she went home from work. That night she had chest tightness, cough; no fever; bloodshot eyes; wheezing. Came back to work Friday (10/30/09) moving with SOB, bad head pressure behind eyes, struggling to breath; swelling of eyes and face. Saw  ..... lungs were clear. Gave albuterol inhaler and tylenol - then went home to rest and was ok after that.
BLOOD CLOTS IN URINE; VISUAL BLOOD CLOTS IN PENILE DISCHARGE; DISCOLOURATION OF URINE; BLOOD DISCHARGE AND CLOTS IN STOOL (CLOTS WOULD FALL OUT WHEN WENT FROM SITTING TO STANDING); This spontaneous report received from a consumer concerned an 86 year old white, not Hispanic or Latino male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, expiry: 23-JUN-2021) frequency one total, dose was not reported, administered on 10-MAY-2021 at 10:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the patient experienced clots in stool which would fall out when patient went from sitting to standing. They are about 3 inches in diameter. He also experienced blood discharge. On 12-MAY-2021, he experienced discoloration of urine with unknown origin. From the night of 13-MAY-2021 to the morning to 14-MAY-2021, he experienced clots in urine and visual of blood clots in penile discharge. The patient was hospitalized on 14-MAY-2021 and the duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discoloration of urine, blood discharge and clots in stool (clots would fall out when went from sitting to standing), blood clots in urine, and visual blood clots in penile discharge. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529768 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood in stool, Discoloration of urine, Blood clots in urine and Penile bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) outcome was unknown.            No concomitant medication provided by reporter. No treatment medication provided by reporter.   This case was linked to MOD-2021-225413, MOD-2021-082958 (Patient Link).   Reporter did not allow further contact
Patient fainted about 10 minutes after shot. Laid patient down got her to raise legs, drink water, ice pack after about 10 minutes patient felt well was coherent. Left pharmacy with mom.
SEVERE aches and chilling.  Severe migraines.  I have never felt this bad in my life.  Seriously contemplated going to ER and I have not been to an ER for 25 years.  The only reason I didn't go is because I was unable to sit up for that long of a period to get there and get checked in. I am scared if I have to get another booster at some point.  This lasted for 48 hours.  I was unable to get out of bed except to occasionally going to bathroom.
Pt devel erythema, soreness, & edema @ inject site same day recvd Td following finger laceration; following day pt devel stiff neck & lumbar back pain w/some radiation to legs; 2 days later pt treated for severe lower back pain & stiffness;
At 4:30 pm patient reported feeling "high", stated he felt like his heart was racing and "waves were going through his body". Vital signs stable; 100% on room air, 124/74, HR 86. Felt tingling at injection site. Most symptoms resolved after about five minutes. Arm soreness remains. Monitored for 30 minutes in room, discharged at 5:00 pm.
Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-JAN-2012, at age 66, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
Fever of 103, vomiting, jerking movements of legs while asleep, twitching.  started 0600 07-05-05.  fever down and appeared ok by noon.
Tinnitus and hyper acoustics in one ear and hearing loss.  Doctor injected steroids into eardrum to help with hearing loss after sending me for an MRI that was clear.   Treatment has had no impact so far.  Also GI issues.  Doctor ran bloodwork, ultrasound and stool test with all normal results.  GI issues ongoing and unexplained.