chrisvoncsefalvay/vaers-outcomes huggingface dataset:
would like to register pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (would like to register pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Aug-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (would like to register pregnancy). On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (would like to register pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.
Swollen red oval started to appear on day 2, about 3 in long and 1 inch tall. Day 3 got bigger and redder.
loss sense of taste; Lost sense of smell; pain in body; chills; Patient died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Patient died) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss sense of taste), ANOSMIA (Lost sense of smell), PAIN (pain in body) and CHILLS (chills). The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, AGEUSIA (loss sense of taste), ANOSMIA (Lost sense of smell), PAIN (pain in body) and CHILLS (chills) was resolving.            Concomitant medications were not reported.  No treatment information was provided.  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.   This case was linked to MOD-2021-201255 (Patient Link).; 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.; Reported Cause(s) of Death: unknown casue of death
Patient states she has been dizzy, nauseous and vomiting since she received the vaccine. She has vomited approximately two times per day and remains dizzy and nauseous. She states she believes the symptoms have gotten worse since vaccination.
8-12-09 Am RN Supervisor received t/c from patients spouse. Reports Patient went to ER had difficulty breathing and chest pain. Had EKG, Labs and received Potassium in ER. Spouse reports today wife c/o "waves in chest". RN Supervisor spoke to spouse. Recommends Patient follow up with PCP or return to ER.
Patient reported that she had muscle weakness and fell the morning of Tuesday 5/25.  She developed a 101.8 fever, chills, and shaking that morning as well.  The fever and chills were gone by Tuesday night.  Wednesday 5/26 she still had muscle weakness and fell.  Thursday and Friday still wobbly and shaky but seems to be getting better.
Beginning the night after receiving the vaccine, I have had noticeable difficulty falling and staying asleep through the night. I retire around 12-1 a.m. and consistently awake between 4 and 6 a.m., unable to fall back asleep. This has led to serious drowsiness during the day. Prior to the vaccine, I would regularly sleep until 8 or 9 a.m.  uninterrupted.
2 inch diameter red rash, hot to the touch and sore.  Patient is currently treating it with Ibuprofen and Allertec otc.
Approximately 5 minutes after administration patient fainted briefly, after a few seconds she regained conciseness and was fine. We put a cold compress on the back of her neck and observed her
Stomachache and headache but was nauseas for days and threw up  attached number 4 from insert for TD  4. Risks of a vaccine reactionPain, redness, or swelling where the shot was given mild fever, headache, feeling tired, and nausea,vomiting, diarrhea, or stomachache sometimes happen after Td vaccination
09:24 am: Pt received vaccine 09:38 am: Pt complained of numbness of mouth (palate ) 09:40 am:  8 oz water given to pt.  b/p 150/80, p73, r20, o2 sat = 98% 10:05 am:  Pt states that he feels better ("mild numbness").  Pt discharged.
1 hour post vaccine, pts wrist started hurting. Pain then radiated up & down arm. Pt took a "pain medication" & an ADVIL (R). She felt better in the morning.
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 60-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
15 minutes after vaccine injection, my son said he was feeling bad, that he need air and water he was dizzy. He stopped talking and his mouth turned to the side. One eye was open the other was shut, he was shaking and had arm movements then he got cold and pale and his eyes were white.
Rash, itchy, on top of both feet and ankles and on both thighs under buttocks. About 24 hrs after receiving YF-vax, Tdap, Typhoid, Hep A, rash resolving after 48 hrs.
7-17-09 pt was given Hep B vaccine at his 10:15 AM visit. Began twitching of left leg and arm upon arriving at home. Parents called Rescue Squad around 5 PM and was taken to hospital and was admitted for one day for observation.  8/3/09 MR received for 7/17-18/2209 with dx: neonatal sleep myoclonus.  Pt presented with multiple episodes of twitching/jerking of extremities which began after receiving Hep B vax. Admitted to r/o seizure.  Neuro consult Impression:  likely neonatal sleep myoclonus. ICD9 780.3
I reported symptoms to CDC initially but they have not gone away, aches, pain, extreme fatigue, nausea daily, vomiting weekly,  bone pain, leg pain,  weakness
Immediate local reaction - redness, warmth, no pruritus reported. Soreness, swelling. Advised cold pack, BENADRYL if needed.
swollen ankles noticed at bedtime when removing shoes, slept & woke up normal, after 3 hrs being up swelling again (but less) the following day no swelling, but noticed rash on stomach that lasted 2 days then was normal.
Patient was given extra flu shot. Patient was given a flus shot on 9/23/22 and on 9/28/22
when we left the clinic (2:20pm) and I put her carseat in the car her head and arms shake for a few seconds. at approximately 4:45 I was going to get her out of her carseat and her head and arms started shaking rapidly for about 5 seconds. she was not treated for it and she has not had any symptoms since.
Tingling in hand and feet; Hard time catching breath; Extreme pain in body; Not able to get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hand and feet), DYSPNOEA (Hard time catching breath), PAIN (Extreme pain in body) and MOBILITY DECREASED (Not able to get out of bed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PARAESTHESIA (Tingling in hand and feet), DYSPNOEA (Hard time catching breath), PAIN (Extreme pain in body) and MOBILITY DECREASED (Not able to get out of bed). At the time of the report, PARAESTHESIA (Tingling in hand and feet), DYSPNOEA (Hard time catching breath), PAIN (Extreme pain in body) and MOBILITY DECREASED (Not able to get out of bed) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-074867 (Patient Link).
RASH ACROSS CHEST DIAGNOSED AS SHINGLES; ONSET OF RASH ONE DAY AFTER HPV #2.
I had been in menopause since I was 50 years old. For about 10 years I haven't had a period and then in January 2021 I began to have vaginal bleeding. When going to the my gynecologist, they immediately did an ultrasound and biopsy and were unable to find the cause for this. I heard that one of the reactions post vaccine was having reoccurring vaginal bleeding. About two months ago, around 08/2022, I was doing normal daily activities and suddenly had lower back pain that eventually went away after 3 days. However, 2 weeks ago, the pain began again and when I stand I begin to feel the lower back pain again. As of now I am still having the lower back pain and also the continued vaginal bleeding.
Headache, Myalgia, NauseaVomiting Chills Narrative:
35 y/o healthy male received Anthrax vaccine #1 and Typhoid vaccine on 16 AUG 07 without significant side effects.  On 03 SEP 07 received Small pox vaccine in left deltoid (no prior history of small pox vaccination or exposure).  On 07 SEP 07 patient experienced sudden, profound left sided sensorineural hearing loss and vertigo which has been persistent and unresponsive to high dose oral prednisone and anti-virals.  12/10/2007 MR received for OVs and audiometric testing beginning 09/03/2007 to 11/27/2007. Medical screening 9/3/07 with pt "feeling fine, no symptoms".  Smallpox vax received. Pt reported back on 9/7/07 with c/o sudden onset L sided hearing loss. No other sx other than fullness in L ear.  DX: Sensorineural Hearing Loss Asymmetrical Initially txd with prednisone and anti-virals. Seen again 9/12/07. Pt now c/o imbalance and feeling like inebriated. Meclizine Rxd for vertigo. DX as above with Sudden Hearing Loss of Unknown Etiology. OV 9/13/07 with c/o severe dizziness, nausea, vomiting, and poor po intake. OV 9/17/07 with (+) nystagmus and falls with tandem Romberg. Pt had Intra-tympanic steroid injection 9/20/07. OV 11/27/07 Pt reports hearing chirping like sounds in the L ear.  No further vertigo or dizziness  Per 60 day follow up: Persistent 100% sensorineural hearing loss L ear. 1/12/2010 Complete deafness (sensor neural hearing loss and absent vestibular functions) has persisted and appears permanent.
Patient received Janssen COVID vaccine on 3/21/21. On 6/22/22, patient admitted to our inpatient facility with acute hypoxemic respiratory failure secondary to COVID-19 pneumonia and type II MI/demand ischemia secondary to hypoxemia from COVID-19 pneumonia. Patient was admitted to our med/surg unit and discharged home on 6/24/22.
Two days after receiving the Gardasil 9 vaccine (shot 1) our daughter started blacking out completely  and having seizures that are very multiple through out the day and night.  She has no energy, no appetite, cannot get up to do anything without either stopping and sitting back down or blacking out simple task like putting away the dishes.  Taking a shower is a HUGE task she blacks out ever time. Her heart rate staying in the high upper 100's and her b/p is very low.  She wants to sleep all the time.
12 hours after injection my temperature went to 101, and I had flu-like symptoms. It began to get better after another 12 hours.
Started to feel lightheaded, with a headache and foggy on Wednesday April 13. Woke up on April 14th with dizziness, later that day I noticed tiny blood spots on my right thigh. Call the pharmacy where I got the vaccine and was advised to go to the hospital right away. I did.  Today, April 15, I?m still feeling dizzy and have brain fog.
Intense general itching and hives. Pt seen in ER Received IV meds. (Meds unknown)
Hospital Course and Significant Findings: 66 yo F with history of atrial flutter status post ablation 2018 currently on Pradaxa, anemia, HTN, psoriatic arthritis, OSA without the use of CPAP, prior breast cancer with bilateral mastectomy who has been experiencing 1 to 2 months of weakness and tiredness and intermittent blood in stool.  She had lab drawn as an outpatient yesterday and found to have hemoglobin of 6.1 so referred to the ER for further evaluation.  Patient had a blood transfusion and hemoglobin has been stable.  EGD, colonoscopy, and CT enterography did not show any gross abnormality revealing culprit for GI bleed.  At this time, GI recommends holding Pradaxa and may likely need further follow-up with Facility for capsule endoscopy and/or push enterography.  E consult will be placed by Dr. at discharge.  Patient was instructed to get repeat labs in 1 week.
Pain, swelling, burning, itching began 2/27 in the AM. Injection site measures 2.5inches on 3/1 at 8:30pm Consistent burning and itching.
Not noted until after vaccine administered that it had expired on 3/24/2019. No adverse reaction/symptoms noted. Patient was notified of expired vaccine and need to repeat dose.
Intense cramps in the middle of night and the irregular start of my period just hours after taking the shot. Intense period cramps and heavy bleeding.
12/21/2021, day of first dose I experienced chills, aches and general discomfort. I developed covid shortly after first dose and I developed ulcers. Second dose was on 03/14/2021 and it wasn't until 04/07/2021 that my ulcers began worsening into mouth, throat, nose. Worsening of arthritis that I did not have before the vaccine. I started having a tingling sensation as well as exhaustion and depression, all of these symptoms are worsening. I am very dizzy and falling all the time.
patient called 12/2/04with complaints of hives since day after vaccination (given 11/20/04) on and off. Told to take Benadryl PRN and ER warnings.
Pt. felt like passing out, pale, nondiaphoretic, throat sensation discomfort, stomach ache....lethargy 3pm- pt was sat on chair, O2sat 90, P 60 O2sat=90, P=60 ammonia inhaled, oxygen placed at 3L, BENADRYL 12.5mg/5ml-10ml given slowly, 1 small sip of apple juice. 3:13-laid on table w/ feet elevation BP 100/60, bp=100/60 - pt awake, answered name, mom's name when asked, but appeared somewhat lethargic 3:20 bp=100/60 3:24 O2=98 p=60- 3L O2 3:30 O2=97 p=60- 3L O2- mom accepts transfer to hospital-911 called, 3:40-paramedics arrived-taken hospital- at 3:45 pm.
pt recv vax P pt exp misuse, improper storage (inappropriately stored varivax;No further details were provided;
Testicles pain; Testicles swelling; slight arm pain sensation; slight disorientation; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation) in a 63-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation). At the time of the report, TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported. Patient reported that he received the vaccine and dont have Lot or any other information regarding vaccine. He experienced testicles pain and swelling days after getting vaccine and it was resolved shortly. Patient reports slight arm pain sensation and slight disorientation all resolved later.
dizzy; chills; joint pain; This is a spontaneous report from a Contactable Consumer. This consumer reporter This consumer reporter for a Unknown male: The Unknown male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced chills, joint pain, and was feeling dizzy. The consumer asked if these were normal side effects of the vaccine. The event outcome was unknown. The consumer asked if patient could take motrin for pain.  No follow-up attempts were possible; Information about lot/batch number could not be obtained
1/6 vaccination That evening, I felt really flushed, really hot in the face. I took a shower, saw rash on neck to collarbone. It got worse in the morning. Conferred with medical professionals within community and recommended to take Benadryl. I took it for 36 hours. After 36 hours, rash disappeared.  2/2 2nd vaccination - no rash
slight itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (slight itching at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (slight itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (slight itching at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-064008 (Patient Link).
Headache, nausea, vomiting, fatigue, hard to breathe, abdominal pain, didn't feel the baby move inside her, still birth.
Severe septic shock, followed by death. Stomach pain, followed by hospitalization, gradual organ failure, septic shock and death.
Patient complained of chest tightness 30 minutes after receiving vaccine, which was her second dose.
DEATH; This spontaneous report received from a consumer concerned 12 multiple patients of an unspecified sex, age, race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after receiving vaccine the 12 multiple patients died from an unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210320422.; Sender's Comments: 20220419102 -covid-19 vaccine ad26.cov2.s -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered Unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report from a contactable pharmacist. A 65-year-old male patient received PREVNAR 13, lot M73332, exp.date Jul2017, NDC number 0005-1971-05, via an unspecified route of administration on left deltoid on 02Mar2016 17:13 at 0.5ml single dose for immunisation. Medical history included ongoing osteoarthritis. There were no concomitant medications. The patient experienced a lot of pain way down his arm on 02Mar2015 and having difficulty holding up his arm on unknown date. It was also reported that the patient may have received injection higher up than recommended. The outcome of the event a lot of pain way down his arm was reported as not recovered while the outcome of the other event was reported as unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
Fever; Chills; Weakness; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 74-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm left on 06Apr2021 12:00 (Lot Number: ER8732, Expiration Date: Jul2021) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypothyroidism, illness from 05Dec2020 to Feb2021 until the middle of February. Caller confirms she was never tested for Covid. Caller confirms that she was sick and because it was the middle of the winter, she toughed it out. Caller states that she was never tested for Covid, but she believes she may have had it at that time. There were no vaccines with in four weeks. Concomitant medications included oral levothyroxine sodium (SYNTHROID) 88 mcg every other day and 100mcg every other day, once a day taken for hypothyroidism, start and stop date were not reported; ibuprofen sodium (IBUPROFEN [IBUPROFEN SODIUM]) taken for an unspecified indication, start and stop date were not reported. Caller states that she was not medically minded but reports that she takes thyroid medication and Ibuprofen sometimes. Caller states on the day of the vaccine, she did not take Ibuprofen, but took one after for the fever. Caller states she does not like medication and was not a pill popper. On 06Apr2021 at 19:00, the patient experienced fever, chills and weakness. Caller states that she had a reaction to her first shot. Fever at 7 pm, along with chills and weakness, it lasted 27.5 hours and at 10:30 last night, it lifted away. Caller states she woke up a little weak and as the day goes on, she was getting better. Therapeutic measures were taken as a result of fever with ibuprofen. The outcome with events pyrexia and chills was recovered on 07Apr2021, outcome of event weakness was recovering.  No follow up attempts needed. No further information is excepted.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received an expired dose of Menveo, which led to expired vaccine used. The health care professional reported that one of the nurses from their facility administrate the vaccine and she did not have the report to provide any data.  The reporter consented to follow up.