chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (652965/0622F) ZOSTAVAX on 20-NOV-2006. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
lupus; she was so sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Diagnosed about 4 years ago. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: LUPUS SYNDROME (medically significant), outcome "unknown", described as "Lupus"; ILLNESS (non-serious), outcome "unknown", described as "she was so sick". The events "Lupus" and "she was so sick" were evaluated at the physician office visit. The patient didn't have Lupus before she got the vaccine and now (as of Jan2022) she had been diagnosed with it. She was diagnosed with Lupus 2 weeks ago (as of 11Jan2022), which was about 1 week after getting the 2nd dose of the vaccine. She started getting symptoms after she received the 1st dose of the vaccine in May2021, but she wasn't diagnosed with Lupus until just recently. She waited all that time to get the 2nd dose because she was so sick. She decided to finally get the 2nd dose due to the Omicron strain, but she was still sick and going to doctors to try to figure out what was wrong, so she doesn't know if it was the 1st dose that did it or the 2nd dose. The doctors don't want to link this to the vaccine, but she felt that it was related. The patient underwent the following laboratory tests and procedures: blood test: unknown results. She had done a lot of bloodwork.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200049289 Same patient/ vaccine, different dose/AE
Pt was seen @ urgent care on 1/14/2021 after vaccine @ 1:30 PM that same day. She reported that ~ 45 mins after receiving the vaccine her lips began tingling & burning. She did 0 have any swelling or SOA.
It started with a very bad sore throat, fatigue and nasal congestion. Chills, body aches, diarrhea, loss of taste and smell. I still don't have my taste or smell. My fever got up to 102.
Patient received as dose of IPOl on 10th December that expired on 7th December 2020, no AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 years old female patient who was administered expired 0.5 ml dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot number: P1F541M and expiry date:7-Dec-2020) via intramuscular route in left arm for prophylactic vaccination on 10th December 2020 (Expired product administered).  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for prophylactic vaccination.  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, 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.
1-hives under lower lip 2-injecction site sore for 5 days 3-injection site became hot, hard, itchy @ 5 days 4-@6 days above spread  in size began taking benadryl 5-area of redness now 6" by 8" still itchy, still red @ 8 days
Around February 16th, (4 weeks after second dose of Pfizer) I developed a swollen lymph node on the left side of the neck just below the jawline. With the swollen lymph nodes came sharp pain when talking or eating. Occasionally with the sharp pain the left side of the neck would swell and I would lose my voice from sometimes up to an hour.  Doctor's visit was made and an ultrasound was scheduled. Ultrasound showed two enlarged lymph nodes. Was given a steroid (prednisone 40mg for5 days) and given 8 weeks until a follow up.  At follow up the pain is nearly gone but the lymph nodes are still the same swollen size. Blood work was scheduled and all came back normal. Approaching 14 weeks with swollen lymph nodes with no sign of improvement with size of swelling.
Redness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness at the injection site but the health care professional (HCP) did not have further details. The reporter consented to follow up. This was 1 of the 5 cases, reported by same reporter.
Information has been received from a relative concerning a female child with the history of vaccination with Haemophilus B conjugate vaccine who on 02/097/00 was vaccinated with MMR. Additional vaccination on 08/28/00 included Hepatitis A vaccine and Varicella virus vaccine live. The reporter noted that the patient has been slow to develop. The child did not sit up until 11 months of age. She did not crawl until 16 months of age. The child did not walk until she was 2 years of age. In January or February of 2001 the patient experienced a febrile seizure. A brain scan revealed that the patient was affected by "flashing lights." It was noted that as of 03/07/01 the child still could not talk. Upon internal review, slow to develop and febrile seizure, were determined to be Other Medical Events. Additional information has been requested. F/U info rec'd indicated that the pt was seen in the ER on  1/9/01 and had a follow up visit at the office on 2/22/01 for an ear recheck and was to return in 3-4 wks for another ear recheck. She stated that there was no documentation at that visit of a developmental disorder. Upon internal review, slow to develop and febrile seizuree, were determined to be Other Medical Events.  Follow up on 06/29/2001: "Lot number for vaccine #2 is not provided, Lot # for vaccine #3 is: 638804/0561K."
Shot was given on 7/23/13, Pts mother called on 7/25/13 and stated that pt. had a big red circle that was swollen and warm at the touch on the (R) upper thigh.
At 8 am, this morning, sharp pains in my stomach started , earlier had some diarrhea , had bouts of diarrhea a couple times after. Stomach having sharp pains and body chills no fever
From Derm Note: Dermatology- Within 3-4 days post-vaccine, patient developed discrete pruritic pink papules on his head/neck which gradually progressed to his upper trunk. He developed a low grade fever (approximately 100 degrees F) and was seen in the ED on 15 June. Patient was diagnosed with varicella secondary to VZV vaccine at that time, and also treated with 5-day course of PO KEFLEX for impetiginized wound on his left elbow. MOP states lesions continued to progress, although patient remained afebrile, alert, active, eating and drinking normally. Patient was then seen in ED last night, as lesions progressed to his lower trunk and legs. He was seen by Infectious Disease and started on PO Clindamycin at that time (1 dose so far). MOP states patient's only other medication is PO BENADRYL PRN for itching (approximately 2-3 times per day).  She states he has otherwise been health, no significant past medical history. No personal or family history of atopic dermatitis, psoriasis, or other skin condition per MOP. Derm T-con-.Called and spoke with mother of patient (MOP) regarding patient's biopsy result showing psoriasiform and spongiotic dermatitis.  Clinicopathologic correlation favors an eczematous process, which may be secondary to vaccine hypersensitivity reaction. Symptoms: RASH and OTH NONSPEC SKIN ERUPTION, FEVER, UNSPECIFIED.
Client developed large red, raised rash 15 minutes after vaccination on trunk of body, arms, and neck. C/o shortness of breath. Had anxiety prior to shot given.. Gave 50mg oral Benadryl and rash and other symptoms cleared within 30 minutes. Advised client to not get 2nd hepatitis  A vaccination.
the next morning and the following two mornings after the shot I had severe headaches.  Theu went away without medication fairly quickly the first two days after I got up.. the third day after about an hour I went out and got some advil to get rid of it.  About a week after the shot I started getting a rash under my arms and in the ground area.  This got worse every dah and spread to .other parts of the body as time went on.  Better today (april.23) but still very uncomfortable.
A consumer reported that her 2 year old son received his fourth dose of Prevnar on 5/15/02 at 24 months of age. Additional suspect vaccines consisted of DTaP, HIB, oral polio vaccine, MMR, Hepatitis B, and Varivax. Subsequent to vaccination, the child was diagnosed with autism. The patient's experience was considered medically important (OMIC). No additional information was availabe on the date of this report.
This prospective pregnancy report concerning a female patient of an unknown age, was received from the patient's sister. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in December 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route of administration, lot number and expiration date were not reported) as a vaccine for Human papillomavirus (HPV). On an unknown date in February 2017, the patient received the second dose of GARDASIL 9 (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date in March 2017, the patient tested positive for pregnancy. The patient sought medical attention and did not receive treatment for the event. There was no additional information regarding the pregnancy provided. Additional information is not expected as there was no contact consent.
Patient reports right arm, right leg, and right face numbness that resolved over the course of 24 hours without treatment. No loss of function, no muscle weakness, normal neurologic exam.
no symptoms have been reported. No additional AE; a 5 year old patient inadvertently received both PROQUAD and VARIVAX at the same time on 8/14/2023.; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient inadvertently received both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, both administered as prophylaxis (strengths, lot #s, expiry dates, anatomical locations and routes of administration were not provided) (accidental overdose). The patient experienced no symptoms (no adverse event).
pain at the site of the injection; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The nurse practitioners said she had approximately five patients that had received the Shingrix vaccine over the last three months and complained of pain at the site of injection. The reporter consented to follow up.
Patient received Flu vaccine at approximately 200 pm on 3/4/13. Later that night, patient developed a red, itchy rash on torso/arms. 5 days later, rash spread to back. Reported to OB/GYN approximately  on 3/15/13, who reported to us. (Pregnant). OB/GYN referred to dermatologist.
Nausea, vomiting, achy joints, fatigue, chills.  Symptoms considerably diminished after 24 hours of receiving vaccine. Symptoms started 12 hours after receiving vaccine.
adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007MZ0A and 0320Z0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Dec-2020. Concurrent medical conditions included Heartbeats irregular (required no treatment change) since 2019. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN CALCIUM (CRESTOR) and VITAMIN C [ASCORBIC ACID] for Prophylactic, GLUCOSAMINE & CHONDORITIN, VITAMIN D3 and PROBIOTICS NOS for Prophylaxis.   On 22-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021 at 10:00 AM, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (adverse event). On 20-Feb-2021, ADVERSE EVENT FOLLOWING IMMUNISATION (adverse event) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  The patient did not specify what the adverse event was.  She did not seek medical attention for the event.  No treatment medication was provided.   This case was linked to MOD-2021-013433 (Patient Link).
severe neurological decline, agitation, stopped eating/drinking, body twisting, repetitive movements,
significant tinnitus, moderate hearing loss, mild dizziness, mild balance problems, and mild headache still as of 7/6/2021.
administered to a patient 7 years of age with no adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case received via health professional. number: 01298571  This case involves a 7-year-old male patient to whom Diphtheria-15/Tetanus/5 Hybrid AC PERTUSSIS/IPV (MRC5) Vaccine [Quadracel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3), Varicella Zoster Vaccine Live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 23-Aug-2022, the patient received 3rd dose of suspect Quadracel vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (lot: C5851AA, expiry date: 25-Mar-2023) for Immunization with no adverse event (product use issue).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     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 the 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.
Pt recvd vax & devel hives & itching all over body; sx persisted for 10 days & resolved w/o treatment;
Developed (R) arm soreness, redness & began spreading around the arm. Patient reports within 12 hours had developed chills, arthralgias and myalgias. By Monday f/u with physician had a (R) arm cellulitis.
pt reports vomiting, diarrhea, and "tightness in chest". Pt states she will seek immediate medical attention for the chest pain she is experiencing
Positive lymph nodes left breast; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: EN6207) as dose 2, single and (Lot number: EN5981) as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "history of stroke" (unspecified if ongoing); "allergies: sulfa drugs" (unspecified if ongoing); "allergies: ace inhibitors" (unspecified if ongoing). Concomitant medication(s) included: REQUIP; PLACID [ETOPOSIDE]; SINGULAIR; LOSARTIN; LASIX [FUROSEMIDE]; PANTAB. The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "Positive lymph nodes left breast". The event "positive lymph nodes left breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional Information: Patient did not receive other vaccine in four weeks. Patient had an abnormal mammogram. Prior to vaccination, patient did not experience covid. Post vaccination, patient was not tested for covid.   No follow-up attempts are possible. No further information is expected.
Starting immediately after receiving the vaccine, I developed a site reaction and then that evening I started feeling tired, fatigued, loss of appetite and weakness. It lasted for about 3 days then resolved. I took an at home test which was negative. I developed a fever of 100.1. I developed an ear infection and went to Urgent Care a few weeks ago and told them all these symptoms I had. They did a POCT COVID test which was negative. As of 05/12/2022 I'm feeling normal again. Near the end of April, neighbors of mine had visited a party and came down with COVID.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose, route and lot# not reported. The patient believed that on an unknown date she had aluminum poisoning and her hair was thinning. The outcome of adverse events was unknown. The relatedness between GARDASIL and adverse events was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Patient developed diffuse body shaking that lasted for several hours.  Onset was about 8 hours after the shot.
This spontaneous was received from a 60-year-old female company representative, referring to herself. The patient had no medical history, concomitant medications nor concurrent conditions. On 18-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not reported). On 20-MAY-2017, the patient experienced injection site reaction, which was swollen, red, itchy, painful and was about 5-7 cm in diameter. On the same day, the patient also noticed "something that looked like shingles" on the inside portion of her lip, extending to the outer portion of her lip and being red and painful. Moreover, there was a bubble on the inside of her lip which was filled with liquid. The patient did not seek for any medical attention, but stated that she would if the symptoms got worse. No treatment was given for the events at the time of the report.  The patient recovered fully from the injection site reaction on approximately 27-MAY-2017 (reported as "in about a week"). The patient did not recover from "something that looked like shingles" on the patient's lip and the "bubble filled with liquid" at the reporting time (reported as the symptoms on her lip were not getting any better, nor any worse at the time of the report). The relatedness between the events and the suspect therapy was not reported. Additional information is not expected as there was no consent for further contact.
Flu like symptoms appeared about 12 hours after the shot.  I felt fine following the shot and when I went to bed that night.  When I woke up the next morning I was achy, feverish, slightly nauseous, very tired.  Symptoms persisted all day.  Slept well that night and by the next morning all the symptoms were gone and did not return.
12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19) in a female patient of an unknown age 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 VACCINE BREAKTHROUGH INFECTION (12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications are provided by the reporter. The patient reports that she knows of 12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19. The patient did not know which brand of vaccine the patients had received.  Company comment This case concerns a patient of unknown age and gender with no relevant medical history provided, who experienced the unexpected event of VACCINE BREAKTHROUGH INFECTION (AESI). The event occurred on an unknown date after the dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable, since there is no information about the vaccines administered. The benefit-risk relationship of Moderna COVID-19    Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history provided, who experienced the unexpected event of VACCINE BREAKTHROUGH INFECTION (AESI). The event occurred on an unknown date after the dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable, since there is no information about the vaccines administered. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.