chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave Moderna COVID 19 vaccine to a 17-year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) in a 17-year-old female 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicine information not provided. Treatment medicine information not provided.
I received my 2nd moderna vaccine on  Friday, May 21st around noon. On Saturday, May 22nd I noticed some tightness in my lower back. On Sunday morning, my period started, over 2 weeks early. It lasted about 3 days with minimal symptoms. Two weeks later, I had my period on its normal cycle (28 days). This also lasted 2-3 days. Symptoms at that time and for about the next 2 cycles were much more intense than normal particularly breast tenderness (it was painful to remove my bra) and moodiness.  My cycle returned to normal by the end of summer.
This case meets criteria for vaccine breakthrough review. SxS include weakness, fevers, SOB, diarrhea.
breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Moderna COVID-19 Vaccine EUA - Slight swelling and soreness at the injection site for 7 days. On the eighth day after the shot I developed redness and a little more swelling and itching. Area is 1 to 1 1/2 inch square.
Approximately 3 minutes  following vaccine administration, patient began to complain of headache, feeling shaken, and described that everything looked brighter.
Mother calling in stating pt had 103 degree fever controlled by Tylenol and Advil. 03/06/2008, with an enlarging, red, painful and swollen area at the site of arm, lateral SC area. She is also using Benadryl 12.5 mg/tsp. Advised to take Benadryl to 50 mg tid and apply ice and perhaps topical Benadryl or anti-itch cream; site redness openly encircling entire area. See PMD if does not clear. Advised we would submit VAERS rpt.
Pt came in 9/19/16 for second BEXSERO and stated she has had migraines since 2 wks after her first BEXSERO. She has never experienced migraines before. Second BEXSERO was given. She continues to have severe headaches and now has neck pain. She is scheduled to f/u w/neurology.
big round swelling and tenderness below where shot was. warm to touch, slightly raised. happened 2 days after vaccine was given.
temperature of 100.2 deg. F; Nauseas; arm is in horrible pain on the injection site.; right after the vaccination she felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 100.2 deg. F), DIZZINESS (right after the vaccination she felt dizzy), NAUSEA (Nauseas) and VACCINATION SITE PAIN (arm is in horrible pain on the injection site.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (right after the vaccination she felt dizzy). On 07-Feb-2021, the patient experienced PYREXIA (temperature of 100.2 deg. F), NAUSEA (Nauseas) and VACCINATION SITE PAIN (arm is in horrible pain on the injection site.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 3 dosage form. At the time of the report, PYREXIA (temperature of 100.2 deg. F), DIZZINESS (right after the vaccination she felt dizzy), NAUSEA (Nauseas) and VACCINATION SITE PAIN (arm is in horrible pain on the injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. Patient took Advil as a treatment drug. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
CHILD'S DATE OF BIRTH WRITTEN AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN SYSTEM WITH DATE OF BIRTH.  CHILD IS TOO YOUNG FOR VACCINE ON 8/26/2021. SEE VAERS #685175 FOR REPORT OF FIRST DOSE ON 8/5/2021.
about 1-1 1/2 hrs p/vax mom said pt began to have trouble catching breath; started crying about 1PM; high ptich cry; cried like that for 6-7 days; seen by MD 20AUG92 was told rxn was due to Pertussis; lt leg was swollen & had induration;
no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 24 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm (lot U020244, expiration date 28-JUN-2023) (strength and dose were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
has a rash that started in her feet, not spreading.  Appears to be mottled, not raised.  Blanching rash.  NO pain, not itching.  Started later the day she got the vaccine. Maybe improving but they are unsure.
death Narrative: Patient was a 71 y/o gentleman with PMHx schizoaffective-bipolar, major neurocognitive disorder, hx covid- 19 in 12/15/20, chronic insomnia, BPH s/p LUTS, OA/DJD at unspecified joint, and acquired hypothyroidism who presented to the clinic for hospital follow up and monitoring while on clozapine. Pt received covid19 vaccine on 2/16/2019 while inpatient, right before his discharge on 2/17/2021.Of note, pt was put on hospice care at the time of discharge to patient's home. He passed away on 2/26/2021. I could not find the death notice in the chart (which usually contains the medical cause of death). This was reported to us from an staff. The following describes his hospitalization: At facility, was noted to be dehydrated and reported to not have been taking his medications or having good PO intake. Per reports from nursing home, patient wasnoted to have difficulty swallowing" and spit up meals and medications. SLP evaluation with concerns for mastication and dysphagia. At time of hospitalization his Na was at 153, also noted to have AKI2. His hypernatremia, aki, and dehydration resolved with fluid replacement. His potassium was also replaced. His constipation resolved with laxatives which also improved his abdominal discomfort. Also, his olanzapine was changed to disintegrating tablet which helped with his intermittent agitation. Currently, he was calm, amenable, and with medication compliance. To help with his poor appetite, his mirtazapine dose was increased to 30 mg from 15 mg. Pt was discharged on 2/17/2021 when family decided to place him under hospice care.
Swelling and large spot on arm at the injection site, with an itchy and hard lump under the skin
Fever chills; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea ) and VOMITING (Vomiting) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (allergy to Remerol) and Latex allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, FISH OIL, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea ) and VOMITING (Vomiting). On an unknown date, the patient experienced PYREXIA (Fever chills). an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with NAPROXEN for Fever, Chills and Nausea, at a dose of 220 mg. On 07-Mar-2021, NAUSEA (Nausea ) and VOMITING (Vomiting) had resolved. At the time of the report, PYREXIA (Fever chills), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-071167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11 May 2021.Added patient demographic information, medical history, concomitant medication, treatment medication and new events
This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided.  On 01-JUN-2017, the patient was vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees celcius to -10 degrees celcius for 390 hours, 55 minutes and in the range -9 degrees celcius to 8 degrees celcius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000680, 1707USA000681, 1707USA000682).; Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000680: US-009507513-1707USA000681: US-009507513-1707USA000682:
I received the second dose of my COVID vaccine in the morning. By that evening I had very strong pain in my left arm and in my shoulders. By midnight that night I had shivers and had to add clothing , but even then I couldn?t be comfortable. The next morning my whole body was hurting, including my muscles all over, but mostly in my buttocks. I had a 100.7 fever and had no appetite. I couldn?t get out of bed until 6 or 7 o?clock that night.  I was in bed and in and out of sleep all day with my whole body hurting. It was certainly an utterly unpleasant experience.
Four days after I developed pain in my chest. Intermittent pain which has required several visits to primary care physician, urgent care, ER, Cardiologist and GI physician. Current diagnosis Prinzmetal angina
first vac was in 4/21 is it too late for 2nd; Sick or in hosp; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first vac was in 4/21 is it too late for 2nd) and ILLNESS (Sick or in hosp) 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 21-Apr-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 (first vac was in 4/21 is it too late for 2nd) and ILLNESS (Sick or in hosp). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first vac was in 4/21 is it too late for 2nd) had resolved and ILLNESS (Sick or in hosp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she need her 2nd Moderna vaccine. Each time she tried she ended up sick or in hospital. No concomitant medications were provided. No treatment information were given.
Adverse event included sudden limpness, unresponsiveness, pallor, and cyanosis.  Called 911 and maintained efforts to revive child.  Event duration lasted maybe 10-15 minutes.  Child was much improved by the time the fire department arrived, and was taken by ambulance to Hospital for evaluation.  Tests included EKG, x-ray of abdomen, blood test, and urine test.  No problems were identified, and the hospital was unable to determine a possible cause of the event.  Child was admitted overnight for monitoring, and no further adverse event occurred.  The hospital indicated that it was unlikely the vaccines taken earlier that morning (DTaP-Hib and PCV) were a factor in the adverse event.  As a parent of the child, however, I am submitting this report because the symptoms our daughter experienced five hours after having DTaP-Hib and PCV vaccines are IDENTICAL to those described in a Pediatrics-published study and occurred in a child under 2 years of age and within 48 hours after administration of a pertussis-containing vaccine, exactly as described in the study.
This case meets criteria vaccine breakthrough review. SxS include cough on Tuesday PTA, weakness Wednesday PTA, Friday PTA positive COVID+ x2 via home test, hypoxia.  Caregiver tested positive.
A couple days after the vaccine I developed an awful and very discomforting Chafing in my bottom area. It got so bad on 12/3 I visited my PCP who stated I had a really bad yeast infection that flared up so bad I was limited in mobility and in so much discomfort I couldn't do anything. I was prescribed an Antifungal pill in which I had to take one that same day and the other this coming Friday 12/10.
tachycardia; pain in her chest; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 31Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tachycardia, pain in her chest. Patient wanted to know if it was recommended to get the 2nd dose of the vaccine. Patient stated that she was concerned about the probability for myocarditis from the second dose and that was why she was calling. She stated that she read people have been getting myocarditis from the second vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested
Within 15min of her shot, patient had tingling inside her mouth & her tongue, her lips were numb, and maybe had some tongue swelling; her breathing was labored (short of breath); her skin was flushed like a sunburn, starting at her head and moving down to her chest. Patient said she didn't mention anything to us (the pharmacy) because she is allergic to other things and didn't think much of her reaction. By 30min after her shot, the reaction was fully formed; all her symptoms went away within an hour without any treatment. Patient spoke with her PCP who told her to not take the second dose.
Arm which is sore; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced arm was sore.   The patient's medical history included back issues. No relevant concomitant medications were reported.   On an unspecified date, the patient received their first dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient received Moderna COVID-19 Vaccine and experienced arm was sore (Pain in arm).  Treatment details included three Ibuprofen for an evet arm was sore.  Action taken with mRNA-1273 in response to the event arm was sore was not reported.  The outcome of the event arm was sore was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Took to emergency, had 2 ear infections, throat infection, respiratory infection, gave antibiotic, sudefed, and mucinex. 2nd time at ER complaining of chest pain, did EKG, took blood, xray-nothing, went to doctor with chest pain, had nose infection, said just sore muscles, said to take motrin. 2nd time at doctors 01/21/2010-had chest pain, hard to breathe, weak-gave motrin and musle relaxants--said sore muscles from coughing.
(9/15/2021)Antiphallic Shock, Dizzy, itchy throat, given Benadryl but continued to worsen. Two epinephrine, albuterol treatment, Ativan, and Decadron was given under nurse/paramedic/ER care. During the ER visit the shock was halted and was discharged. Later that night had tingling started at extremities but quickly covered my body and had to visit another ER. Was given IV and Norco for pain.
Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006022:
From initial information at manufacturer, it was reported that a 19 year old female patient received Menomune A/C/Y/W 135, UB034AA, on 7/2/01. Route/site were not reported. Patient had cultures sero group C. On 2/15/03, patient had blood cultures and was positive for ? of meningitis group C. Patient was hospitalized for 4 days, then died on 2/18/03.
After about an hour I started to feel pressure on the left side of my neck up to my left jaw. My left arm was swollen and my blood pressure was at 135/85, my BP is usually 110-60 or lower. I had taken it before the vaccine and it was 97/63. I still feel pressure, stiffness on my neck, this after almost 24 hrs.
PT here for Johnson and Johnson shot, received at 1841. Immediately after vaccination, PT presented with pallor and diaphoresis, reported his vision was starting to be blurry/go black. No LOC noted. SPO2 was 95% RA and HR was 52 sitting in chair. Unable to obtain BP at this time. PT was able to transfer to WC and assisted to lay down on cot with feet elevated, reported that he felt much better lying down. VS at 1849 were: BP 104/60 laying, HR 63, SPO2 99% RA. PT was offered and consumed 2 juice boxes, reported that he felt to be to baseline. At 1854, PT sat at edge of cot without difficulty, reports that this happens every time he gets an injection. VS at 1858: Sitting BP 122/84, HR 78, SPO2 98% RA. PT educated on vasovagal reactions, encouraged to notify future healthcare workers of this history prior to vaccination. PT verbalized understanding. VS at 1904: BP 129/68 sitting, HR 64, SPO2 98% RA. PT was able to stand without difficulty and with appropriate balance. VS at 1908: BP 118/72 standing, HR 64, SPO2 98% RA. PT was able to walk a short distance with steady gait, denies further dizziness, vision changes, reports he feels ?normal?. PT?s demeanor was affable and appropriate. VS at 1911: BP 130/68 standing. PT exited facility at 1913, will be at home with his mother.
Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in both arms,  facial swelling, face became tingling and flushed feeling. Slight tingling in tongue. She took Benadryl with mild relief. No shortness of breath or difficulty swallowing. Tingling of tongue and arms is gone but still has facial swelling and redness.
Patient reported to the pharmacy today with complaint about having swelling in her right thumb and right side which started the next day after she received the vaccine. Patient reported that it is better now.
has a cold; She's never slept this much in her life; She just feels off; fever; lightheaded/dizzy; achy; chills; headache; tired and fatigued; eyes hurt; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Right on 27Mar2021 11:15 (at the age of 38-years-old) at dose 1, single for covid-19 immunization. Medical history was none. There were no concomitant medications. The last vaccine she had was the flu vaccine and she only received the flu vaccine because she was pregnant, that was years ago. The patient experienced chills, headache, tired and fatigued, lightheaded/dizzy, achy and eyes hurt on 27Mar2021. She had gone for running Saturday(27Mar2021). She thought maybe she was tired and achy from running. On Sunday morning, 28Mar2021 she felt a little better, so she went running and ran some errands. She had fever on 28Mar2021, had a cold on an unspecified date. She works in public schools and they look at her like she has the plague. She wanted to know if these side effects were rare. She still feels really tired at the time of report. She still has a headache, her eyes hurt. She went to bed at 7:00PM at night on 28Mar2021 and woke up for work next morning around 5:00AM on 29Mar2021. She still felt bad, so she called out of work, she went back to bed after calling out of work and slept until 8:00AM. She said that she has never slept this much in her life. She was reluctant about getting the Covid-19 vaccine to begin with and now she regrets getting it. She just feels off. The vaccine was not administered at Facility. The events not resulted in emergency room or Physician Office. Patient had no relevant tests. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events lightheaded/dizzy and fever was recovering, outcome of the events (She's never slept this much in her life, feels off) was unknown, outcome of rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.