chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic case of diarrhea- the loose stool had a strong chemical stench; chronic case of diarrhea- the loose stool had a strong chemical stench; I did about 7 bowel movements all night until next morning; This is a spontaneous report from a contactable consumer (reported for himself). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E19262; expiry date: not known), via an unspecified route of administration in the right arm on 23Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included 2 heart surgeries- 1 triple and 1 double. Concomitant medications included lisinopril, metoprolol, and tamsulosin. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jan2021 01:00 (reported as 'Sunday evening past midnight'; pending clarification), the patient had to get up and run to the bathroom with a chronic case of diarrhea- the loose stool had a strong chemical stench. He did about 7 bowel movements all night until next morning. The patient asked if it was a reaction to the COVID-19 (vaccination). The reported events were assessed as non-serious. The outcome of the events was recovering.
Gallstone attack , required gallbladder removal surgery. Gallbladder was inflamed and infected and had formed gangrene. I had no symptoms ever that I have issues with the gallbladder until this day.
Vaccination was administered in left upper arm, 01/18/2013 pain in left arm and on left side, feeling of fatigue during the next few days, I got sick in the night from 01/25/2013 to 01/26/2013 - had diarrhea and had to throw up (at same time), mild diarrhea lasted for the better part of a week, had shingles the beginning of February, first symptoms around 02/01/2013, was treated with antivial drug (Zostex), visited Doctor 02/06/2013, started treatment with Zostex 02/06/2013.
Patient developed high fever 104.3 and diffuse fever 3 days after administration. Patient has no history of egg allergy. He previously received injection of flu vaccine. His rash extended over entire body, which spread rapidly after 3 days. Rash was maculopapular, and became confluent over trunk. Pruritic.
Information has been received from a registered nurse concerning a 33 year old female patient who delivered a baby on 04/24/2004 and had been breast feeding who on 04/26/2004 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Two weeks later, on approximately 05/10/2004, the patient developed a rash, difficulty moving her finger, hand, left knee, and big toe and her milk dried up and she was not able to breast feed.  It was reported that the patient had successfully breast fed 2 infants previously for 11 months and 6 months.  It was reported that the patient was very upset.  Unspecified medical attention was sought.  Additional information has been requested.
This spontaneous case reported by a patient, describes the occurrence of pain in extremity (arm soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A and 010M20A) for COVID-19 immunization. Concurrent medical conditions included herpes (NOS), keratosis and iodine allergy. Concomitant products included Valtrex (valaciclovir hydrochloride) for herpes (NOS), Flexura (metaxalone) for muscle relaxant. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 13, 2021, patient experienced pain in extremity (arm soreness). On Jan 16, 2021, pain in extremity (arm soreness) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. After 6 weeks, patient noticed her keratosis (skin cancer) faded and completely gone with 70% improvement. No treatment medications reported.
Pain, swelling at vaccine site, pain all over, fatigue, malaise, headache, loss of appetite, vertigo.
Patient did not know she was pregnant at the time of vaccination and was vaccinated with Anthrax and HPV
Encephalopathy (brain fog)  fatigue  dizziness  headache  lymphadenopathy  tingling  flushing hypotention petechiae myalgia pain chills influenza-like symptoms malaise weakness neuropathy including hypoesthesia (numbness, tingling)  paresthesia visual disturbances (light sensitivity)  muscular weakness shortness of breath
Patient presented from school a request for an accelerated HEP B. series. Patient was injected with Engerix  B on day 0 (08/21/2021), and again on  day10 meant for day 7 (9/4/2021). And when patient presented here for day 30 dose as requested by his school, that was when we realized that patient had been injected with Engerix B outside ACIP/CDC Guidelines.
pt recvd vax;17jul95 devel varicella like rash which spontaneously resolved w/ in 10 days; reporter felt like exp related to vax;
Patient came to pharmacy the day after vaccination with redness about 2 inches and swelling at the injection site.
The first time I had the adverse event was after the second vaccine, I started swelling at the base of my neck in the V of the collar bone and under my arm, behind my knees, and at my ankles.  This lasted approximately one month but I did not see anybody for this.   After the 4th vaccine, the symptoms were more pronounced with a the swelling about the size of a half of a tennis ball at the V in my neck/collar bone, and swelling under my arm, at my knees, and ankles.  All of my lymph nodes were swollen.  It was very painful and uncomfortable.  This was only on the side of the body where I received the vaccine.  The doctor told me to take Ibuprofen and gave a prescription for 7 day regiment of Prednisone to help bring down the swelling.  This lasted approximately three months.
strep throat; Experiencing streptococcus and fever.; This is a spontaneous report from a contactable consumer (father). A 18-year-old male patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0165, Expiry Date: unknown) on an unspecified date in left arm via unspecified route of administration as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In the meantime, between his first and second dose of the vaccine, on 08May2021 07:38 PM, the patient had strep throat. It was reported as the patient was experiencing streptococcus and fever. The patient went to emergency room on 08May2021 and received prescription for the Antibiotics and Tylenol for the fever, got discharged from emergency room on the same day. The outcome of the event strep throat was reported as not recovered, and outcome for event fever was reported as recovering. The reporter stated that the patient is due for his second dose of vaccine on the next day and wanted to know if they need to reschedule it or could still receive the second dose on the next day of reporting date.  Follow up information has been requested.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.   On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of 23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.  Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 03-APR-2019, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012652: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660:
Shortness of breath; Itchy; loss of taste; loss of  smell; Palpitation; Dizzy; Big red bump started with a size of dime on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PRURITUS (Itchy), AGEUSIA (loss of taste), ANOSMIA (loss of  smell) and PALPITATIONS (Palpitation) in a 45-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.     The patient's past medical history included COVID-19 (Positive) on 05-Jan-2021.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red bump started with a size of dime on the injection site). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), PRURITUS (Itchy), AGEUSIA (loss of taste), ANOSMIA (loss of  smell), PALPITATIONS (Palpitation) and DIZZINESS (Dizzy). At the time of the report, DYSPNOEA (Shortness of breath), AGEUSIA (loss of taste), PALPITATIONS (Palpitation), DIZZINESS (Dizzy) and VACCINATION SITE ERYTHEMA (Big red bump started with a size of dime on the injection site) had not resolved and PRURITUS (Itchy) and ANOSMIA (loss of  smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 antibody test: unknown (Positive) positive for COVID-19.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.      This case was linked to MOD-2021-098918 (Patient Link).
Optic neRve Swelling in Right eye causing Loss of  sight, 20-30 minutes after  2nd CoviD Vaccine . Damage is  PeRmanont due to Lack of Blood Flow
First dose was given on 20Aug2019 / Second dose had not been administered at time of call; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 20th August 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient did not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow up. This case has been linked to US2021082155, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082155:same reporter
Sudden hearing loss developed in left ear which started a few weeks after vaccination, followed by intensifying vertigo, dizziness and nausea over the next month, followed by a persistent dull ache on the left side of head that continues today (7/10)
Pneumonia with collapsed lung; Pneumonia with collapsed lung; Scheduled to take 2nd dose of vaccine on 26 Mar 2021, 6 weeks after; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia with collapsed lung/pneumonia and scheduled to take second dose of vaccine on 26 Mar 2021/inappropriate schedule of vaccine administration.  The patient's medical history was not provided by the reporter. No concomitant medications were reported.  On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 61016308) in the right arm for prophylaxis of COVID-19 infection.   On 06 Mar 2021, the patient experienced pneumonia with collapsed lung and was hospitalized.  She was scheduled to take second dose of vaccine on 26 Mar 2021.  Treatment for the event included hospitalization for pneumonia with collapsed lung.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, pneumonia with collapsed lung was unknown.  The outcome of the event, inappropriate schedule of vaccine administered was considered to be resolved.; Reporter's Comments: This case concerns an 80-year-old who had second dose scheduled 6 weeks after first dose (inappropriate schedule of product administration) and also experienced collapsed lung/pneumonia. Although a temporal association exist, based on the information provided, the event of collapsed lung/pneumonia is assessed as unlikely related.  Pneumonia is due to an infective etiology.  The event of inappropriate schedule of product administration is assessed as not applicable.
About 2 and a half weeks after the second Covid19 vaccine (around April 15) I noticed a few red spots on my chest and legs. As time went on more spots started appearing on my back and legs. (They never itched or hurt). On May 17, 2021 I went to my dermatologist and he thought it was Eczema and he prescribed Clobeasol Propionate ointment. As time went the spots increased and got larger. On June 21, 2021 I went back to my doctor and he did a biopsy on one of the lesions. A week later, the Special Stain Pathology and Tissue Exam Pathology cane back as Guttate Psoriasis. He prescribed Calciopoyriene and Betamethasone Diprolonate ointment. This ointment did nothing. Awaiting approval or Otezla.
3rd hep B vax recvd 13JUN90 & on 05SEP90 had a neg HBSAB titer. 2 addt'l doses of vax led to a pos HBSAB titer
I had a headache and felt very very exhausted for 3-4 days. About 2 weeks later I started having a dizzy/light headed that lasted from 10pm until 10am the next day. I went to ER, labs, EKG, and ct scan came back normal. I still been dealing with bad headaches and had another dizzy spell a few days after hospital visit.
About 6 days after receiving the Moderna COVID vaccine in the left arm, shot injection site became itchy, red and warm to touch. 1-2'' immediately around the injection  site.
Menstrual cycle became VERY irregular; Also became very heavy; besides very frequent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Apr2021 11:00 (Lot number: EW0167) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Product: COVID 19, brand=Pfizer, Lot number: EW0167, Lot unknown: False, Administration date=Mar2021, Administration time=11:00 AM, vaccine location: Right arm), administration date: Mar2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Apr2021, outcome "not recovered", described as "Menstrual cycle became VERY irregular"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Apr2021, outcome "not recovered", described as "Also became very heavy"; POLYMENORRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "besides very frequent". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, polymenorrhoea.  Additional information: The patient did not receive any other vaccine within 4 weeks. The patient used to have be 100% regular mensural cycles prior to the first vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was tested for covid  post vaccination on 03Jul2021 by nasal swab and result was negative. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional via phone. This case involves a 16-years old female patient who received an 0.5ml dose of expired vaccine MENACTRA on 20-Nov-2018 (lot number: U5752AA, expiry date: 16-Nov-2018) via unknown route in the deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLULAVAL and Gardasil for Immunisation on 20-Nov-2018. It was a case of actual medication error due to expired vaccine used because the patient had advertently administered an expired MENACTRA (single dose vial). The MENACTRA expired on 16-Nov-2018 and it was administered on 20-Nov-2018. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Information has been received from a nurse practitioner concerning an 8 year old male with no known drug allergies or medical history who on 25Jun98 was vaccinated with a dose of varicella virus vaccine live. On 20Feb2004 the pt presented to a school nurse with a mild case of chicken pox. Unspecified medical attention was sought. It was noted that the school in this county had an outbreak of chickenpox. No product quality complaint was involved. It was also reported that 2 additional children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. No additional information is available.
Chills, headache, joint pain, low grade fever, fatigue, tiredness  Rest, OTC Tylenol/Ibuprofen, Water intake
On 6/5/96, she received a Hep-B vaccine, after which I was informed. There was no suspected reaction. On 7/5/96, she received another Hep-B vaccine, no suspected reaction. My husband and I put our trust in her doctor. We discussed with the doctor, the benefits and risks of vaccines and he was firm in his beliefs that all children should be fully vaccinated. We inquired why it was necessary for us to sign a release prior to vaccinations. We never did get a straight answer. We discussed postponing the vaccine schedule because of our concerns of administering so many at one time. Our concerns stemmed from a friend's child contracting polio from the live oral vaccine. This prompted my husband and I to do some research. The visit to the doctor's office on 8/5/96, is a day I will never forget. Following a debate with her doctor, I gave in. Upon administration of the Tetramune, my child began violently screaming in a high pitch that I had never heard before. I looked at the doctor, he left the room. I tried comforting my baby to no avail. She continued to scream as we went to the car. She was becoming exhausted but continued screaming, alternating with limpness. When we arrived home, I noticed she was extremely hot to the touch. She continued this new screaming type crying for several days. She was very agitated. This was not the same child I took into her doctor's office that day. We returned to his office a month or so later. He dismissed my concerns as nonsense. He told me that if I didn't agree with his philosophies, that I should find a doctor who did. We did find another doctor that believes in nutrition and prevention. Our child has not received any more vaccines. She was breast fed for 37 months. Aside from her agitated temperament, she is well. I may never know exactly what happened that day, but I do know something went wrong. I pray that someday God can give me an answer. I will never know how my normal, natural baby was supposed to be. As a parent, it is my responsibility to protect and love my children, do all that I can. Something neurologically occurred that day; something unwanted, unnecessary. I would do anything to take that day back. My husband and I will live with the sadness and guilt we feel for all the days of our lives. We wanted you to know what happened, so that hopefully, it can spare others from harm.
41 yo female chronic smoker with PMHx of Migraine currently in no treatment came in to de ER with severe bilateral muscular leg pain. Patient was found with severe CPK elevation ( baseline 47,400) elevated AST (baseline 515) elevated ALT (baseline 141) . Patient denies use of statin or medications, viral hepatitis titer negative and no known other cause of CPK elevation. Naranjo adverse drug reaction probability scale reported as 5 which may be consider as a probable vaccine reaction.
Redness (3 inch x 3 inch), warmth of left deltoid. Ice applied.
Recent prev URI. 12/4 pt presented in ER numbness in hands, headaches, dysphagia diffuse weakness, unable to walk. Pass TIA/CVA, dyspnea, intubated 12/6, R pneumonia = sputum, infused immunoglobulin 32gm x 5 doses, no improvement pt awaiting transfer to hospital.