chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Urge to go; Stomach cramps/stomach pain got worse; Gut pain / stomach pain; The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas; Headache; Churning; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain) and ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (with a very low zero resistance.) and Lung cancer (survivor more than 9 years). Concomitant products included PREDNISONE for COPD.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 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 DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain), ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas), HEADACHE (Headache) and NAUSEA (Churning). At the time of the report, DIARRHOEA (Diarrhea), DEFAECATION URGENCY (Urge to go), ABDOMINAL PAIN UPPER (Stomach cramps/stomach pain got worse), GASTROINTESTINAL PAIN (Gut pain / stomach pain), HEADACHE (Headache) and NAUSEA (Churning) had not resolved and ACNE PUSTULAR (The large yellow puss filled pimples lasted about 1-2 weeks/they were on my upper torso areas) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Stomach scan: normal (normal) 2-3 stomach scans and not showing anything.         No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-312685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received on 27-Oct-2021 and contains no new information .
Painful itch was migrating around my body - now just on my arms.  I have seen many doctors.  Some believe this is caused by the pneumococcal vaccine. I can't sleep, it is worse at night.  I really need help ASAP PLEASE !
The injection was extremely painful and immediately after receiving my 2nd dose I began to get a headache and felt tired.  Later that day I also had diarrhea and it has continued up to present time as I am reporting this on Thursday December 2, 2021 at 11:27 am.  Since the evening of the 2nd injection on 11/29/2021 my arm has been warm to the touch at the injection site.  This has continued everyday  as well as a very sore arm since the time of injection until present day.  As of yesterday evening, I also noticed my upper arm was red and hot surrounding the injection site.  There was also a large lump in my underarm which was about 4 inches in diameter.  I also had a stiff neck on the left side on Monday 11/29/21 and Tuesday 11/30/21.
After dose 2, I have vaginal bleeding the day after.  Last period ended 8May, next period not due until 2Jun.; After dose 2, I have vaginal bleeding the day after.  Last period ended 8May, next period not due until 2Jun.; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included type 2 diabetic. Patient had Mild allergy to asparagus (facial hives). Concomitant medications included insulin glargine (LANTUS); insulin lispro (HUMALOG). Patient did not receive any other vaccines in 4 weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient received previously first dose of vaccine and After dose one, her period arrived 8 days early. The patient experienced after dose 2, she has vaginal bleeding the day after. last period ended 8may, next period not due until 2jun. on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist referring to 5 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 17-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
large 12x10cm red, hard, warm area lt arm;no fever;began 12hr p/vax;raised in size;
It was stated that approx 1 hour after getting the Covid Vaccine she developed SOB. It was stated that she was given Benadryl 50 mg IM and Epi pen  0.3 mg sq. It was stated that she got the vaccine at 1330 and the reaction began at approx 1430 hours.  She states that she has allergies to bees, meds and foods. She states that she feels the same way as a major allergic reaction. She states that she feels like her throat is itchy and scratchy. She states that it feels like her throat is gong to close. She has more problems with coughing than she does with SOB. H She denies any headache, neck, chest or abd pain, numbness or tingling. She further denies any N/V, Dizziness, fever or chills, blurred or double vision, photophobia. Respirations are without shoulder lifts or intercostal retractions. She is primarily coughing. She is able to speak in 3 - 5 word sentences. No drooling are noted, mild stridors are noted. Lung sound are clear and equal bilateral.  She appears to be atraumatic without signs of gross deformity.  She moves all extremities well and equally without other c/o pain or discomfort. She appears to be in no acute distress.  Patient discharged home and referred to PCP and allergist
Rash spread to face, neck, chest, up to eyebrows intensifying with itching interrupting sleep; Interrupting sleep; Mild rash on chin and jaw; This is a spontaneous report from a contactable consumer (patient) reported in response to non-Health Care Professional letter sent in cross-reference case. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198, Expiration date was not reported), via an unspecified route of administration, in left arm on 23Feb2021 at 14:30 (at the age of 47-year-old) as DOSE 2, SINGLE for COVID-19 immunization in public health department. Relevant medical history reported as none. Family medical history relevant was reported as none. Concomitant medication included metronidazole (FLAGYL) on 24Jan2021 with stop date as 31Jan2021 was prescribed due to bacterial vaginosis following hysterectomy, levocetirizine dihydrochloride (XYZAL) on 01Sep2020, still ongoing and melatonin on 01Jan2020, still ongoing are taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264, Expiration date was not reported), via an unspecified route of administration, in right arm on 27Jan2021 at 16:30 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization in public health department and experienced mild rash developed on chin within 48 hours. Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours a day and severe rash eyebrows down to chest itching interrupting sleep. On 25Feb2021, patient experienced mild rash on chin and jaw. On 28Feb2021, rash spread to face, neck, chest, up to eyebrows intensifying with itching interrupting sleep. These events resulted in visit to physician office. The patient was not hospitalized, and no emergency room visit due to the events. Patient reported that she was fine now. Vaccination administered at military facility was reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. Relevant testes were reported as none. There were no predisposing factors and culture was not preformed. The primary infection site was reported as face, neck and chest. Both vaccinations are included as the same reaction with the exact same timing occurred with both. At time of first dose Flagyl was prescribed due to bacterial vaginosis following hysterectomy. Therapeutic measures were taken as a result of all events which included Allegra, Singulair, Doxepin all was started on 10Feb2021 and stopped on 19Mar2021 and Elidel. Three antihistamines were prescribed and helped with ability to sleep but redness and daytime itching continued for several weeks. The outcome of the event rash spread to neck, chest, up to eyebrows intensifying with itching interrupting sleep was reported as recovered on 15Mar2021, while the other event was recovered in 2021. No follow-up attempts are possible. No further information was expected.
Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered.   Information about lot/batch number has been requested.
Information has been received from a physician concerning a 9 year old patient who on 8/14/95 was vaccinated with a dose of varicella virus vaccine live. On 6/15/03, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446, 0409USA01855 to 0409USA01869, 0409USA01871 to 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Information has been received from a consumer concerning her 17 year old daughter for the Pregnancy Registry for GARDASIL who on 28-MAR-2007 was vaccinated with her first dose of GARDASIL (lot# not reported).  On 30-JUL-2007 the patient was vaccinated with her second dose of GARDASIL (lot# not reported) and was pregnant.  On 08-AUG-2007 the patient was vaccinated with her third dose of GARDASIL (lot# not reported).  The date of conception was 22-JUL-2007 (LMP approximately 14-JUL-2007).  The patient sought unspecified medical attention and her outcome is unknown.  Attempts were made to receive additional information, but this case has been lost to follow-up.  No additional information is expected.
Rcd Influenza vaccine on 9/12/12, felt immediate tingling to entire arm. Worsened next 24 hours. No SOB. No itching to mouth/ lips/ ears. Felt dizzy & arm (R) swollen on deltoid area.
INJECTION SITE PAIN Narrative:  INJECTION SITE PAIN LASTED~1 DAT
Left leg became red and swollen on 1-24-14, given 1-23-14. Pt advised to heat/cool for comfort, move, use ibuprofen, and report to Med. provider with concerns/change in signs/symptoms.
This spontaneous report as received from a registered nurse refers to a 23 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Slight nausea, needed to take deep breaths. After getting home cooking and eating, then realized swelling of throat occurred as had difficulty swallowing. Usual allergic reaction afterwards, body begins sequence of burping, encapsulating food items in saliva and continue to burp until the food comes out.  All food that has gone thru produces stabbing pain at mouth of stomach and has began to produce bloating.  Just as symptoms were realized to be present,  I consumed benadryl,  holding my Auvi-Q close.   Submitting this report, prior to finalizing the complete reaction. Spouse has been informed and asked to monitor.
stomachache ( ever time she eat); diarrhea,; dizziness (she fell very weak); arm sore a little; fell very weak/is weak; get sick very easy; thinking at they given the germ; felling tired.; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little) and ASTHENIA (fell very weak/is weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 18-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little), ASTHENIA (fell very weak/is weak), ILLNESS (get sick very easy), VACCINATION COMPLICATION (thinking at they given the germ), FATIGUE (felling tired.) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little), ASTHENIA (fell very weak/is weak), ILLNESS (get sick very easy), VACCINATION COMPLICATION (thinking at they given the germ), FATIGUE (felling tired.) and CHILLS (chills) outcome was unknown.            Tx: try not to. Only Advilin liquid.   This case was linked to MOD-2021-021692 (E2B Linked Report).; Sender's Comments:  MOD-2021-021692:
seizure like event on way home from receiving 2 ml vaccine (Rota, DTaP, Prevnar, IPV, Comvax) 12/26/07-records received for DOS 11/17-11/19/07-C/O abnormal movements and fever. Temp 38.4. Eyes deviated right, bilaterally and up. Arms flexed.
Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and was not responsive for about a minute. After that time, the patient came back to consciousness and was able to articulate her symptoms, She felt warm for a few minutes and was brought an ice pack to cool down.
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Generalized Fatigue, head aches, body aches and nausea x 2 weeks
Per patient received COVID 19 vaccine on 1/27/2021 and by 1/29/2021 started having symptoms: Pressure headache all over head, sensitivity to light, nausea, vomiting and decrease in appetite.  Per Client was able to take extra strength Tylenol and Ibuprofen with minimal relief. Per Client was not until Sunday, 1/31/2021 that all symptoms had resolved. Per Client will plan to follow up with PCP prior to receiving second dose of COVID 19 vaccine.
first Moderna Covid-19 dose received while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (first Moderna Covid-19 dose received while pregnant) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS (MULTIVITAMINUM) from 25-Feb-2021 to an unknown date, COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) from 25-Feb-2021 to an unknown date and FISH OIL (FISH OIL NATURE MADE) from 25-Feb-2021 to an unknown date for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 07-Oct-2021. On 15-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (first Moderna Covid-19 dose received while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (first Moderna Covid-19 dose received while pregnant) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Prenatal screening test: 26-mar-2021 (normal) no genetic defects, foetus male gender. On 26-Mar-2021, Ultrasound ovary: hz (normal) ovarian cyst on left ovary noted.     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.
Reports about 1 week later noticed a swollen "lump" along with some achiness in Rt. shoulder, really hurts when lays back in recliner.  HCP told him that the swelling was lymph node which swelled due to vaccine and that he has arthritis in his joint which was irritated by vaccine.
Irregular period; Worsening symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 40's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Irregular period". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Irregular period"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Worsening symptoms".  Additional information: The patient was in early-mid 40s otherwise healthy female. She experienced irregular period after second COVID vaccine and worsening symptoms after boosters. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PUNCTURED VACCINE STORED IN REFRIGERATOR FOR LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS PASSED; ADMINISTERED VACCINE STORED LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS HAD PASSED; This spontaneous report received from a pharmacist concerned a 31 year old female. The patient's height, and weight were not reported. 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: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-OCT-2021, the patient experienced administered vaccine stored longer than 6 hours approximately 24 hours had passed. On an unspecified date, the patient experienced punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored longer than 6 hours approximately 24 hours had passed and punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed was not reported. This report was non-serious.
pt recvd vax 28JUN93 & on JUL93 pt devel erythema multiforme, arthralgia & a fever; No further details were provided;
Hives appeared on left arm 30 minutes after administration. The evening of the vaccination patient experienced 104 F fever. 3 days later she experienced pain at the site of the injection with a raised bump with a diameter of 2 to 2 and 1/2 inches in the diameter
Patient developed generalized hives 18 hours after immunizations which resolved spontaneously within 24-36 hours with no treatment.
11:30 PM on 9/28/2023 6-8 welts appeared on inner right forearm. I applied cortisone cream to stop the itching. Within 20 minutes the itching stopped. The welts were gone by morning ( Friday 9/29/23). They reappeared on Saturday, 9/30/23 at approximately 6:30 AM, in the same location. There were several raised and pink/opaque in color itchy welts that disappeared within one hour. The same looking welts appeared again on Sunday, Monday,, and Tuesday October 1-3.  At times there were 4-5 and sometimes only 1. Again, they would disappear within an hour.  On or around Tuesday night or Wednesday they appeared on my inner upper right arm and on my inner upper left arm. I took zyrtek and the hives stopped.