chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was not aware I was pregnant at the time of vaccination but found out shortly after. I later suffered a miscarriage and it appears that the baby stopped developing shortly after I received this vaccine. Timeline: March 31st - received 1st dose of Covid-19 Pfizer vaccine while on my period. My period had started on March 28th. Period ended after 5-7 days as usual and then spotting returned a couple days later, which is highly unusual for me and caused concern. (No sexual activity during those few days so it couldn?t have been implantation bleeding). May 1st - Took a pregnancy test after my period was a week late and it was positive. May-early June. Began experiencing typical pregnancy symptoms (morning sickness, frequent urination, bloating, abdominal growth, constipation) and assumed I was having a normal pregnancy. June 2nd visited OBGYN for what should have been my 9 week appointment/first ultrasound. Dr could not see a fetus and the gestational sack was much smaller than expected. I was informed I had miscarried. Since we could not see any embryo, the growth likely stopped early in the pregnancy, which seems to line up with when I got the 2nd dose of the vaccine. They recommended treatments to expel the remaining tissues, which I followed in the coming weeks. Complications from excessive bleeding resulted in an ER visit and ultimately a D and C to clear remaining tissue.
CHEST TIGHTNESS , DIFFICULTY BREATHING AND SCRATCHY THROAT TREATED WITH STROIDS ,BENADRL AND EPI
mild fever; Diarrhea; weak; soreness around injection site; headache; chills; body aches; fatigued; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (weak), VACCINATION SITE PAIN (soreness around injection site), HEADACHE (headache) and CHILLS (chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced FATIGUE (fatigued). On 26-May-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (weak), VACCINATION SITE PAIN (soreness around injection site), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced PYREXIA (mild fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 27-May-2021, DIARRHOEA (Diarrhea), ASTHENIA (weak), VACCINATION SITE PAIN (soreness around injection site), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigued) and PYREXIA (mild fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No reported concomitant medications.  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. Further information has been requested.   This case was linked to MOD-2021-182943 (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. Further information has been requested
The same evening, lethargic, runny nose.  The third or fourth day, still lethargic, runny nose, diarrhea and rash.
Patient was nervous about getting the shot. After getting she said she felt like her heart was racing and she had nausea.  She also felt like her body was cold.
Deceased; Toe infection; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Deceased) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) capsule for Prostate cancer.    Concurrent medical conditions included Prostate cancer (Received enzalutamide).   On 24-Sep-2020, the patient started ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) (Oral) 160 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2020, the patient experienced LOCALISED INFECTION (Toe infection). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOCALISED INFECTION (Toe infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection. The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Sender's Comments: This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection.  The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Reported Cause(s) of Death: Deceased
I am not on Birth control. I am not sexually active. My thyroid/hormone levels were checked in February 2021 and were normal. I again had my thyroid/hormone levels checked 11/23/21 and they are in normal range. My diet, exercise, stress level, no changes. My cycle is 3 days on the third of every month. I had a normal cycle 10/3/21-10/6/21, first vaccine was 10/18/21, I bled again, extremely heavily, out of norm., 10/19/21 through 10/26/21. Did not have my regular cycle on 11/3/21. I got my second vaccine on 11/8/21 and started bleeding again that same night, 11/8/21 through 11/20/21. I went to the Dr. on 11/23/21, but things had seemed to subside, they took blood samples to check my thyroid/hormones and advised to follow up for any further abnormal bleeding. I started bleeding again 11/28/21 to present, heavily and experiencing severe cramps.
This is a spontaneous report from a contactable consumer calling on behalf of her husband via a non-clinical study program, Pfizer. A 65-year-old male patient received first dose of PREVNAR 13, 0.5 ml single and influenza vaccine at 1 DF single, both for immunization, intramuscular, in the left upper arm, on 29Jan2015. Medical history included pain, nerves pains, depression, anxiety. Concomitant medications included oral tramadol 50 mg tablet, two tablets every three hours, for pain, trazodone 100 mg once a day at night time, for nerves pains to relax at night and for depression, methadone 5 mg tablet twice a day for pain, omeprazole 20 mg once a day for stomach, clonazepam 1 mg tablet, two tablets a day, for anxiety, oral hydrocodone 5 mg tablet, one to two tablets twice a day, vitamin C supplement, vitamin D, vitamins (Rainbow Light) once a day, vitamin D and oral gemfibrozil 600 mg tablet twice a day for cholesterol. On 30Jan2015 the patient experienced left upper arm red, hot, and swollen and it hurt him really bad for 2 days. She had put a line around the red swollen area to see if it was going to spread. The reporting consumer was also concerned about the flu shot administered along with PREVNAR 13 and was wondering if it is safe to take it again. The patient was getting better at time of report. Follow up (02Feb2015): New information from the same contactable consumer includes: reporter inquiry and events outcome.
Medication error:  Pt wanted Janssen and got Pfizer.  He needed a 1 1/2 long needle and all the long needles were blue.  The vaccinator was handed a syringe with a long blue needle with Pfizer in it by mistake.
Pain at injection site. (Lasted < 24 hrs) Fever 2 days/2 nights Fatigue 2days/2 nights
Area of injection turned red 2-3 inch diameter and itches. Been putting aquaphor cream on the area. Started treatment yesterday and it looks the same. Not itching quit as much but still is itchy.
nausea; lethargy; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2022, 24 hrs after receiving Shingrix, the patient experienced nausea and lethargy. In May 2022, the outcome of the nausea and lethargy were recovered/resolved.   It was unknown if the reporter considered the nausea and lethargy to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix vaccine into right arm and about 24 hours post vaccination, on 14th May 2022, the patient experienced nausea and lethargy that lasted for about four days. The patient did not have any further information about the vaccine. The reporter did not consent to follow up.
Immediately after Td vax, PT slumped over, unresponsive. B/P 76 systolic, EKG rate 49.
The patient experienced a local reaction in his left deltoid region. (erythema, edema and tenderness to palpitation.
-12:13- patient received COVID-19 vaccine and grew very anxious after receiving it. Staff recommended patient to lie down on the cot to relax and do some deep breathing. Parents stated she is taking a prescribed medication to help with anxiety, but did not remember the name of it.  -12:15- patient had a panic attack and was very worried, anxious and scared and stated "my heart hurts, its beating fast." Vital signs taken: Blood pressure 163/86, HR 145, Sp02 99%. We called 911 and requested EMS. About 3 minutes later, the patient felt nauseous and stated "I feel sick, I need to throw up" and patient threw up in trash can. We provided continued to monitor the patient closely, water and deep breathing techniques to help relax the patient.  -12:23- EMS arrived, handoff report provided and EMS took vitals signs and was provided consent by patient's parents to transport the patient to the Hospital.
Tenderness, swelling, and redness at injection site; tenderness and soreness has spread to shoulder and has intensified.
Approx 5 hours after receiving vaccine, developed an aching sharp pain between my shoulder blades worsening with inspiration,  intermittent mild chills,  and fatigue. Pain between my shoulder blades lasted 4 hours, until i took tylenol and  went to bed.. i woke up 5 hours later and the pain was now a dull ache.
Approximately 15-30 minutes after receiving the vaccine the patient reported numbness on the left side of her face. Also reported intermittent tingling in fingertips of both hands and feet. Prescribed a medrol dose pack that evening and had taken one dose. By 0630 today (12/22) reported that the  numbness was 95% improved.
Vaccine was stored in the freezer instead of the temperature range indicated on the package (2-25 degrees C). Vaccine was administered to this patient while not knowing it was stored improperly.
We accidently gave a 17 year, 11 month, 12 day old male the Moderna vaccine - it is not approved for anyone under the age of 18.  Reported it and told to fill out a VAERS.  I tried calling patient however was not able to talk personally with him.  I left a detailed message asking him to call me on my direct line.
Pt was schedule for her 2nd Covid vaccine. Appointment was scheduled wrong, instead of 3 weeks from the date of her first dosage it was given by mistake 1 week earlier than what she was supposed to.  Pt is awarded that she needs to come back in 3 weeks and repeat the vaccine again.
Tightness in chest/throat, racing heart, dizziness, tingling, fluttering in chest, sharp pain in chest/back, fatigue. Treatments-Xanax, benadryl, ibuprofen. Time course-on and off for 3 1/2 weeks and counting
Awoke with body aches, muscle spasms to the point my body felt like it was having a seizures. Chills, pain in joints and muscles.  I constantly felt like I had to stretch my body out.  Jerking movements for close to two hours.  Husband gave me ibuprofen, which did help.  Nausea close to the end of the second hour,  but never vomited.  No HA.  Started approx. 12:22 am and started to feel better approx 2:00 am.   Did not go to work today as I was tired and sore.  Slept most of day.  Seem better now, 3:30 pm.
Chills, fever 99, sweats. Severe muscle weakness x 2 weeks, gradually improved over the next several months. Tylenol & fluids
Disabling headache, fever, chills, muscle aches, nausea, fatigue, arm pain for 16 hours. Fatigue during the next 6 hours.
Beginning 3 days after 3rd dose of Hep B adult vaccine, pt began to have severe muscle pains.   Generalized pain persists.
reporting an expired dose of Daptacel was inadvertently administered, no AE; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 18 months old female patient who inadvertently received an expired dose of 0.5 ml (first dose) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date: 18-Sep-2019, via intramuscular route in the left thigh on 27-Sep-2019 as prophylactic vaccination (expired product administered).  The patient's past vaccination(s) included 3 previous doses of Pentacel.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccination included Hepatitis A vaccine.   It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
headache; shakes; couldn't hold anything/could not hold phone; didn't feel well; fever 102.1; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided.  Concomitant products included MORPHINE, GABAPENTIN, ATORVASTATIN, OMEPRAZOLE, ESCITALOPRAM, FENOFIBRATE, ARIPIPRAZOLE, TRAZODONE, TOPIRAMATE, METOPROLOL, FLUDROCORTISONE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced TREMOR (shakes), HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts). On 24-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (shakes) and HEADACHE (headache) had not resolved and HYPOKINESIA (couldn't hold anything/could not hold phone), MALAISE (didn't feel well), PYREXIA (fever 102.1) and PAIN IN EXTREMITY (arm hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 102.1 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient received Moderna Bivalent as a booster when not yet authorized.   Spoke to mother who reports 24 hours of fever and fatigue, however resolved within 48 hours post vaccine.  Denied any complaints at time of phone call.
ear pain above my ear on my head; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR PAIN (ear pain above my ear on my head) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced EAR PAIN (ear pain above my ear on my head). At the time of the report, EAR PAIN (ear pain above my ear on my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment medications provided.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.61.  Concomitant products were not provided.  Vaccine was moved to fridge on 30-Mar-2021. Vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen.   On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. Vaccine BUD date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
sore arm with mild or moderate pain after getting Shingrix, feel tired,  have muscle pain,  mild headache,  chils
2/14/2021 hives and urticaria covering scalp, forehead, neck, back, breast, stomach and arms which got progressively worse. 2/15/2021 Shot of adrenaline administered IM with prednisone 20mg BID x 5 days and Benadryl 50mg QHS. Symptoms unresolved as of 2/19/2021 and returned to Urgent Care for treatment. No change in diet, laundry detergent, personal hygiene regimen or medications.
T101, tiredness, weakness, insomnia, nausea, abd pain x 5 days;
Information has been received from an NP concerning a 2 year old male with no known drug allergies who on 5/4/01 was vaccinated with varicella virus vaccine live. On 5/9/01, the pt developed lesions. On 5/11/01, the pt was seen in his physician's office with 100 lesions on face and trunk, with a temperature of 101F, malaise and itch. The pt had been exposed to another child at school who had varicella more than 2 weeks prior to the pt's eruptions. On 5/11/01, diphenhydramine HCI (Benadryl) was ordered as needed. Additional information has been requested.
Hep B #2 - 1-2 hours later experienced, heavy chest (not SOB) weak, fast heart beat, pale, slept 14-16 hours - did not take anything for symptoms. Rest of household was experiencing GI issues - client did not experience these as the other household members.
High fever, nausea, and vomit after 12 hours of injection. The symptoms were gone after 72 hours. Only the nausea is still last forever.  I can't eat anything and feel nausea all the time. Today is the 5th day. I feel so weak because I can't eat anything. Drinking only water make me feel nausea too. I have a bit of grape jam (2 tablespoons a day) and 200 ml of water.
Fluvirin with thimerosal given to OB pt.  LMP: 04/03/2009. EDC: 01/08/2010.  Pt does not have an OB/GYN.  Pt notified on 11/06/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/19/09 Medical records received. OB records. Pt pregnant received H1N1 IM vax on 10/29/09 pt. was 30wks pregnant. No adverse event noted, normal IUP.