chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnancy; A spontaneous pregnancy report  was received from other healthcare Professional concerning a 32 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history, as provided by the reporter,  included one prior pregnancy. The first pregnancy ended on 15 Nov, 2017 with full term birth of the child. No history of pregnancy complications and infant abnormalities.   The patient's medical history also included allergy to Darvocet and demeral.  No concomitant medications were reported.  On 13 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch no. 031L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  The patient's last menstrual period was on 20 Aug, 2020.  The estimated date of conception was not provided and the delivery due date was estimated as 27 May 2021.  On 13 Feb 2021, the patient was exposed to mRNA-1273 vaccine. She would like to be enrolled in the pregnancy registry. No treatment information was provided.  The outcome of the event, exposure to vaccine during pregnancy, was  unknown.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired) and FEELING ABNORMAL (Feeling heavy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B212A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired), FEELING ABNORMAL (Feeling heavy), INSOMNIA (Insomnia/she will wake up at 3-4 am and won't be able to go back to sleep) and PETECHIAE (Petechiae on her abdominal/Petechiae on her chest). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired), FEELING ABNORMAL (Feeling heavy), INSOMNIA (Insomnia/she will wake up at 3-4 am and won't be able to go back to sleep) and PETECHIAE (Petechiae on her abdominal/Petechiae on her chest) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  Company Comment: This case concerns a 58-year-old female, with no relevant reported medical history in this case, who experienced the non-serious unexpected AESI event of Petechiae. The event occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine. At the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-433967, MOD-2021-433568 (Patient Link).; Sender's Comments: This case concerns a 58-year-old female, with no relevant reported medical history in this case, who experienced the non-serious unexpected AESI event of Petechiae. The event occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine. At the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mild fever/chills;  Migraine developed overnight;  9/22/12 afternoon - severe migraine, fever, hypertension & low O2 stats; 09/23/12 continued migraine, trouble breathing, hypertension, muscle aches.
MCU4 vax administered left upper area 3-16-10. Upper arm redness and itchy 3-17 and 3-18-10.
I was falling asleep and my heart rate suddenly increased dramatically and I had what felt like random heart palpitations. It was at 110 BPM  consistently for 5 minutes. I sat up, drank some water, did some deep breathing including valsalva maneuver, and I was able to get it to come down to 90-100. I was able to fall asleep but it never went down further to my knowledge.
It was reported in a published article, title as stated above that a 17 year old female who was vaccinated with GARDASIL. The patient was referred for new onset vision loss in both eyes 3 weeks after being vaccine. A standard dose of 0.5 ml was injected intramuscularly into the left deltoid without any resulting skin reaction. Her medical history was significant for depression treated with quetiapine. Three weeks following vaccination, she developed painless vision loss in the left eye followed 2 days later with painless vision loss of the right eye. The patient denied any viral prodrome. On examination, visual acuity measured 20/60 in the right eye and 20/100 in the left eye. Intraocular pressure measured 14 mm Hg in both eyes, and there was no conjunctival injection, no anterior chamber cells and no anterior vitreous inflammation on dilated fundus exam she was found to have multiple creamy chorioretinal infiltrates in the macula extending into the id-periphery, left eye greater than right. On fluorescein angiography, the lesions demonstrated early hypofluorescence and late hyperfluorescence. Systemic evaluation was within normal limits and included a complete blood count with differential, tuberculin skin test, chest radiograph, lyme titres, rapid plasma regain and fluorescent treponemal antibody. There was no family history of autoimmune disease. The patient was diagnosed as having acute posterior multifocal placoid pigment epitheliopathy (APMPPE) and observed. After 5 days, the patient's vision deteriorated to 20/400 in the right eye and count fingers at six feet in the left eye, and fundus exam demonstrated chorioretinal scarring in the macula with persistent activity of the lesion margins. At this time, because of the scarring, the diagnosis shifted to ampiginous choroiditis, and oral prednisone 1 mg/kg/day was initiated. The prednisone was successfully tapered off within 3 months without recurrence of the choroiditis, but extensive macular scarring remained. The final visual acuity was 20/50 in the right eye and 20/60 in the left eye. The authors stated that this case does not prove causation but the temporal relationship between GARDASIL and onset of an aggressive ampiginous choroiditis is intriguing and may shed light on the immunological triggers involved in posterior non infectious uveitis. Upon internal review, vision loss was considered to be an other important medical event. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Left arm pain  Left neck pain Left arm numbness and tingling constant Left leg intermittent numbness and tingling Nausea Dizziness Muscle spasm of the left side of the neck  -Treatment: cyclobenzaprine nightly, warm compress to the left neck, supplements encouraged, zofran prescribed for nausea.
After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I became sick.
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Pharmacist gave second dose of expired vaccine which was placed in refrigerator on 07-MAY-2021 for over 30 days. Box was in fridge and they inadvertently grabbed without realizing the expiration date.
PATIENT CAME TO PHARMACY AND SHOWED ME HER RIGHT ARM. IT WAS RED AND INFLAMMED. LOOKED LIKE SHE HAD A SMALL BRUISE WHERE THE INJECTION WAS ADMINISTERED. SHE SAID IT STARTED ON 9-24-19, BUT HAD NOT SPREAD DOWN HER ARM AND STAYED LOCALIZED TO HER UPPER DELTOID AREA. SHE SAID SHE HAD NOT TAKEN ANY ANTIHISTAMINES OR ANTIPYRETICS. SHE STATED TO NOT HAVE A FEVER. I ADVISED HER TO TAKE EITHER TYLENOL OR IBUPROFEN IF IT WAS TENDER OR IF SHE DEVELOPED A LIGHT FEVER AND TO ALSO TAKE BENADRYL OR ANOTHER ANTIHISTAMINE TO HELP WITH THE REDNESS AND SWELLING, AND IF IT CONTINUED TO GET WORSE TO CONSULT WITH HER PRIMARY CARE PROVIDER.
Following vax, noted large red hot swollen arm, feverish (temp not taken); started a cough 7 days p/vax, runny nose, pale, cough worse choking w/cough-weird sound like croup;
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 26-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
Information has been received from a registered nurse in a medical center employee health department concerning a female resident physician at the medical center, who on unspecified dates in 2001 was vaccinated with first and second doses of varicella virus vaccine live. It was reported that she now (approximately June 2005) has a negative titer. There was no product quality complaint reported. The patient sought unspecified medical attention.
However, the day after my injection I had light bleeding for 5 days which required light tampons to control; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8732), via an unspecified route of administration, administered in left arm on 27Mar2021 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included vitamins nos. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient started a light period on Sunday which continued for 5 days. She had a Mirena IUD for almost 7 years (second one inserted 2 years ago). She don't have a period with Mirena; every couple months she will spot for a day but it does not require a tampon. However, the day after her injection she had light bleeding on 28Mar2021 for 5 days which required light tampons to control so it didn't ruin her clothes. Treatment was not received for the event. The outcome of the event was recovered. Event was reported as non-serious.
Patient had Anthrax vaccination on 5/1/08 and developed increasing redness and welling. Was seen at MC ER on 5/3/08 and transferred to MC for definitive care. On exam, L upper extremity with very large cellulitic area extending across the deltoid, biceps and posterior left upper arm. Area of induration was present and appeared somewhat fluctuant anteriorly. This area measured 15 by 20cm. Diagnosed with L upper extremity deep soft tissue infection. Area was incised and debrided in the operating room and intraoperative cultures were taken. Hospital admission for IV Vancomycin treatment. Discharged on 5/4/08 with Vicodin and Clindamycin. Wound packing q day. Open wound to L upper arm measures 4.5 inches by 2 inches by 1.5 inches. 5/21/08-records received for DOS 5/3-5/6/08: DC DX: Cellulitis possible reaction to anthrax vaccine. Deep soft tissue infection, left upper extremity. Incision and debridement of left upper extremity soft tissue infection. PE: fluctuance and cellulitis, pain over injection site.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.
Relaxing watching TV wearing shorts and t-shirt, A/C on at 77, suddenly overtaken with extreme cold and body aches about 8:30pm. Sat outside in 85 degrees for awhile to try to warm up. About 9pm got in the walk-in shower and sat on bench super hot water. Got out of shower at 9:40pm my skin beet red mostly my chest. Still freezing and body aches. Put on sweatpants and long sleeve t-shirt. Now have A/C off and windows open, 82 degrees outside. My temp taken before I started this form was at 98.7. I ache all over and am freezing. Not shivering though. But have goosebumps on arms under sleeves. I am very uncomfortable. It is now 10:35pm.
Received COVID vaccine on 1/23/21 and 1/2/21.  On 3/26/2021 developed cough and nasal congestion.  Tested positive for COVID.
Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (right arm) on 22Jan2021 17:30 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included lisinopril from an unspecified date for an unspecified indication.  The patient previously took Codeine and Compazine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 (13:00), the patient experienced fatigue, headache, weakness, nausea, and tingling on right side of body. There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Patient received COVID booster shot and reported feeling light headed while sitting in observation about 5 minutes later. She fainted and fell backwards in the chair. She lost consciousness and hit her head on the pavement. She revived about 30 seconds later and had some confusion for about 1 minute, then was A &O x 3. Patient was assessed by staff and EMS was called and arrive 5 minutes later. She received a 3 inch diameter scrape on her forehead.  Vital signs were within normal limits and stable. After consultation with EMS, patient was transported to hospital. After the incident, the patient reported that she has a history of syncope related to needles and vaccinations. This was not reported to staff prior to the vaccination.
mild throat tightness Narrative:  approx 15 mins after vaccine administered employee started having mild throat tightness -- 25mg po benadryl given -- within 10-15mins, symptoms resolved - she was evaluated by a MD --
received first dose on February but did not get second one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose on February but did not get second one) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose on February but did not get second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose on February but did not get second one) had resolved.            Concomitant medications were not reported. Treatment medications were not reported.
Prickliness and numbness in throat after 20 minutes, re-lost sense of taste and smell (had COVID 2 months prior and lost sense of taste and smell)
sore arm; occasionally a headache; mild fever; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious courtesy case received from a other health professional via Pfizer.  This case involves a 59 years old and unknown gender patient who experienced sore arm, occasionally a headache and mild fever while receiving vaccine yellow fever vaccine  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect yellow fever vaccine produced by unknown manufacturer (with an unknown strength, formulation, batch number and expiry date) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed sore arm (pain in extremity), occasionally a headache (headache) and mild fever (pyrexia) (unknown latency).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
CLIENT HAD A SEIZURE AND WAS SEEN IN THE ER AT HOSPITAL BY DR PER MOTHER.
PATIENT HAD PFIZER VACCINE  Dose 1 date: 12/30/2020,  Dose 2 date: 01/20/2021, AND TESTED POSITIVE TO COVID.
This case was reported by a healthcare professional and described the occurrence of fever in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 October 2011 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination, the subject experienced fever, headache, muscle pain and joint pain. At the time of reporting the events were improved. Follow up received from the nurse practitioner on 08 November 2011. On 6 October 2011 the subject received a dose of FLULAVAL (0.5 ml, unknown route, left deltoid). On 08 October 2011, approximately two days after the vaccination with FLULAVAL, the patient experienced fever, headache, muscle pain and joint pain. The lot number was provided by the nurse practitioner. At the time of the follow up report, the events were improved.
Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length of her vaccinated arm and into her hand. Started feeling hot and started to produce a small patch of hives on the outside of the throat and chest. Did vigorous windmill motions with vaccinated arm.  She had a feeling of slight unwellness that was followed by a rush of energy.  As we leave the store and start to drive home her hives are a little bit worse and she says she feels a little lightheaded and has some heart palpations. But is still reporting a rush of energy. By the time we get home 10 minutes later hives,  lightheadedness, and heart palpations have resolved.  She feels great the rest of the day. Next day slight redness around the injection site and arm a bit sore. The following day redness is gone but a slight rash is starting to show up around the neck. 5 days later, the rash becomes inflamed, sore, hot and itchy, hives are full upper-body flareups. She takes Allegra 24 for hives control. Rash comes and goes daily.  Acts more like hives. Allegra 24 controls hives mostly along with icing. After a few days, the effectiveness of the Allegra 24 is not as efficient with the neck rash. Switches to Zyrtec 24 which seems to provide better relief from both hives and rash around the neck. Sees Dr. April 29th. He advises not to take a second dose of Pfizer at this time and prescribes her an EpiPen.
Strange headache started on 4/9 - similar to migraine but duration was longer and pain switched sides.  Mostly disputed by 4/14.  Woke up in the middle of the night of 4/14 with feeling that bed was violently spinning.  Thought it was a bad dream, got back to sleep.  When I woke up in the morning, I sat up and fell back on the bed because the room was violently spinning.  Vertigo persisted when turning head to the right.  Was eventually able to stand up very slowly and carefully.   Once vertical, felt like walking on a rocking boat throughout the day.  Violent spinning any time I tried to lay down.  Had to sleep sitting up for several days.  Took 600mg 3 times a day and 25 mg meclizine 3 times/day.  Symptoms improved slightly at night. Symptoms are still continuing.  Have not been able to drive.  No history go vertigo prior to this episode.  Strange headache comes and goes.  Some mornings wake up with head feeling very full and pressure.
Patient's wife states that patient has had diarrhea since the vaccine. In addition to the diarrhea, states he has had painful bowel movements and feels like knives in the rectal area. He had a stone like object come from his rectum and pain was relieved for a few days then pain has returned. Also, patient is weak. They have tried immodium and is now using vaseline and hemorhoid cream.