chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported having scabbed sores on the outer left arm that started to appear on 1/15/23. Patient did not receive any new medications or consumed new foods recently. Patient also reported having numbness and tingling to the left little finger and ring finger on and off.  Recommended patient to follow-up with physician for further treatment and care.
pt recv vax 22DEC97 & did not have antibody titer;3JAN97 pt exp chills & 4JAN98 pt exp a full blown case of chickenpox w/@ least 100 on face along w/6 pox under arm;also exp T102;
Information has been received from the mother of a female (age not reported) in November 2007, was vaccinated with the second dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). The mother reported that her daughter developed three yeast infections after receiving the second dose of Gardasil (lot # not reported) in November 2007. The patient status's was reported as not recovered. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of passed out in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX and PNEUMOVAX. In September 2018, immediately after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), syncope vasovagal (serious criteria GSK medically significant) and dizziness. On an unknown date, the patient experienced fall and concussion. On an unknown date, the outcome of the passed out, syncope vasovagal and dizziness were recovered/resolved and the outcome of the fall was not recovered/not resolved and the outcome of the concussion was recovering/resolving. It was unknown if the reporter considered the passed out, syncope vasovagal, fall, concussion and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm and PNEUMOVAX in the right arm. Shortly after receiving the vaccines, she felt dizzy and had to sit down for a little while. When she tried to walk to her car, she passed out and had to go to the emergency room. The patient was not admitted to the hospital and states that she was told she had a vasovagal syncope reaction. Approximately 1 month after receiving the vaccine, she fell and got a concussion. The patient was still recovering from the concussion. It was unknown if the reporter considered the passed out, syncope vasovagal, fall, concussion and dizziness to be related to PNEUMOVAX as well. The patient would like to get the next shot at her doctor's office so she could lie down. She has never had vaccine available. She was halfway through the 6 month time period. She asked what could you do to make the vaccine available to me at her office. Consent to follow up was provided.
tone in her ear; can't hear; This spontaneous report was received from consumer on 11-FEB-2021, concerning a 67 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced tone in ear and hearing problem  The patient's medical history was not provided and Concomitant  medication was not provided. The patient received suspect product  mRNA-1273 on 14/JAN/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:029L20A) intramuscularly  for prophylaxis of COVID-19 infection lab data note provided event is tone in her ear, loud ringing, cant,hear out come of the even unknown  The patient received the first dose of moderna vaccine on 14Jan2021 and today have to receive the second dose. Informed that the same week from the first shot she started to had a tone in her ear, can't hear, she feels a loud ringing. Today still on going and getting louder every day. She does not know if it is because of the vaccine or not. Action taken with the  dose of mRNA-1273  in response to the events was not reported
Upon the patient coming to the clinic on 4/27/2021, it was found that the RN had given the patient a Kinrix vaccine on 12/01/2020 which is indicated for 4-6 year olds and a Twinrix vaccine on 11/02/2021 that is for ages 18 years and older, and the patient was only 1 year and 6 months old at the time.  The patients mother stated she did not have any reaction or problems after receiving the vaccine. After talking with the NC Immunization branch, regarding future doses, it was deemed that a report needed  to be made.
seizures 6 days p/1st vax tx w/Phenobarb & Dilantin-still not totally controlled;
Got real sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date : 08-DEC-2022 Reporter's Comment: The patient self-reported this case. The patient recently had shingles vaccine and got real sick for about 3 days. The patient asked was it possible that he/she could shed the virus and gave it to someone else.  Additional Supportive Information: The case had been linked to US2022AMR184546, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR184546:Same reporter.
Low grade fever, Tylenol etc. Local erythema/blistering at injection site-Topical bactroban. "chest tightness" resolving over weekend.
PARKINSON'S DISEASE; BLEEDING; NARCOLEPSY; ADRENAL INSUFFICIENCY; BLOOD CLOTS; SLEEP APNEA; This spontaneous report received from a patient via a company representative concerned a 50 year old of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. 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 patient was severely vaccine injured and experienced Parkinson's disease, bleeding, narcolepsy, adrenal insufficiency, blood clots, sleep apnea, and dysautonomia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding, narcolepsy, sleep apnea, adrenal insufficiency, blood clots and Parkinson's disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230160590- Parkinson's disease, bleeding, narcolepsy, adrenal insufficiency.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0:20230160590- Blood Clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
This spontaneous report was received from a registered nurse and refers to a 18 month old child of an unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with the first dose (1 vial/once) in the three dose ROTATEQ for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported) at 18 months which was later than the recommended starting age, for ROTATEQ. No adverse effects reported.
Received vaccines at well check 1/3/11, that night developed seizures x 2/short, few hours later along with fever and then severe worsening of GI symptoms.
Very itchy arm that has persisted, this far, to a month after getting the vaccine. At the injection site and around that general portion of my upper arm. Sometimes it's perfectly fine, sometimes it's red or pink and either will or will not be itchy as well. If I scratch at it too much, which I try really hard not to but it's really hard not to, and then the little rash-looking areas turns into a small area of mini skin hives. Still redish/pink and itchy. Then I try not to mess with it for the most part, but it's just consisted since then. Idk if this is a me problem, specifically cause I got some weird skin hive stuff going on actually on my eyes at night (randomly) that randomly occur. And that started way before I got the vaccine. With the hives on my arms, it will persist for a while at a time and go away before coming right back again as itchy as ever. It's been basically every single day since I got my vaccine that these side effects have been going on. #StillSupportIt lol. (:
No adverse event; Received Monovalent booster instead of Bivalent; he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot); This spontaneous case was reported by a patient and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Monovalent booster instead of Bivalent), EXTRA DOSE ADMINISTERED (he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot)) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Monovalent booster instead of Bivalent) and EXTRA DOSE ADMINISTERED (he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Monovalent booster instead of Bivalent), EXTRA DOSE ADMINISTERED (he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  It was reported that patient went to the pharmacy to receive Bivalent Moderna COVID-19 vaccine a couple weeks ago. He does not remember the exact date. But he received the Monovalent booster again by mistake. He states that the pharmacy informed him later that they administered a Monovalent booster by mistake.  No treatment information was provided.
IRREGULAR MENSTRUAL CYCLE, EXTREMELY HEAVY MENSTRUAL BLEEDING CAUSING HOSPITAL ADMISSION FOR ANEMIA.
swollen eyelids within 35-45 minutes of shot, normal next morning.  no swelling at shot site, slight arm soreness overnight.
she stated that they were just itchy; Pityriasis rosea; She stated she did not get the second dose of vaccine because she was worried the events would be worse.; hives - big one on her back and a couple of little ones on her chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives - big one on her back and a couple of little ones on her chest), PRURITUS (she stated that they were just itchy), PITYRIASIS ROSEA (Pityriasis rosea) and PRODUCT DOSE OMISSION ISSUE (She stated she did not get the second dose of vaccine because she was worried the events would be worse.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced URTICARIA (hives - big one on her back and a couple of little ones on her chest). On an unknown date, the patient experienced PRURITUS (she stated that they were just itchy), PITYRIASIS ROSEA (Pityriasis rosea) and PRODUCT DOSE OMISSION ISSUE (She stated she did not get the second dose of vaccine because she was worried the events would be worse.). The patient was treated with STEROIDS (topical) for Pityriasis rosea, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives - big one on her back and a couple of little ones on her chest) and PRODUCT DOSE OMISSION ISSUE (She stated she did not get the second dose of vaccine because she was worried the events would be worse.) had resolved, PRURITUS (she stated that they were just itchy) had not resolved and PITYRIASIS ROSEA (Pityriasis rosea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 and contain significant information. The event "Pityriasis rosea" and missing dose and treatment has been updated.
no adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22a) for COVID-19 prophylaxis.     No Medical History information was reported.  On 07-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported.  Total 2 patients were administered with the expired dose of vaccine on 07-Apr-2023. One patient received expired vaccine as first dose and other  patient received vaccine as a 2nd primary dose.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719341 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719341:Patient
Pain in left arm especially at injection site but extending to elbow and up to shoulder. Pain was not enough to warrant pain medication. Today it is mostly just at injection site and is noticably less. Also had some tingling sentaion on my elbow and back of my hand, like an insect was crawling there but wasn't. That only occured one day, the day after the injection then stopped.
tingling on the neck started 2 days out from vaccination and lingered through the 3rd day out, moderate pain of inejction site began 1 day out from vaccination and lingered for 2 more days
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 21-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature   excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
Pt. presented to her PCP with swelling in the left axilla region (approx. diameter 10mm). She was prescribed a steroid and an antibiotic.
faint pink moderately fine morbilliform eruption mostly on trunk;upper extremities & neck;T101.1;remained of exam WNL;
Approx. day 12 post injection noticed uneven redness adjacent to and in front injection site.  Today, day 14, redness has spread and raised.  Resembles a figure 8 with a broad bottom.  Slightly itchy.
During the evening after the influenza and pneumovax vaccine, began to not feel well with headache, nausea and stomach pain. Right arm became swollen and red. The next day was spent in bed, taking tylenol for pain still in right arm. Early the next day at 0300, was nauseous, still in pain, weak, stood up from bed and had syncope. Taken by EMS to local hospital. Admitted, given fluids and iv antibiotics for presumed cellulitis of right upper arm. sent home on po levaquin. recovered fully.
Developed rash evening of vaccination and following day diffuse rash on entire body. Took steroid injection and 11 days of PREDNISONE. Seen by Allergist and Dermatologist. Having skin biopsy today 11/23. Unsure if caused by flu shot or interaction with other medication. Still under treatment.
Information has been received from a physician concerning an 85 year old male with age related macular degeneration, normal tension glaucoma and cataracts who received a dose of ZOSTAVAX (Merck) (date not provided). It was reported that the patient underwent cataract surgery on his right eye on 02-FEB-2011 and subsequently developed dendritic keratitis in the right eye. The patient was seen for an evaluation in the physician's office on 10-MAR-2011. The physician stated that the patient responded well to stopping his topical steroid and that he had been treated with ZIRGAN 5 times a day for the past week. The physician gave the patient an eye exam which showed his vision had improved from 20/50 to 20/20. There was a small healing line on his cornea but no true dendrite and no inflammatory signs. The patient was to stop all his medication except for XALATAN and to return to the doctor if he had any reoccurrence of corneal issues. Subsequently it was reported that on 10-MAR-2011 the patient recovered (conflicting date on 09-MAR-2011 was reported). The patient felt that he had an allergic reaction to the drops status post cataract surgery. The doctor stated that although the cataract surgery and dentritic keratitis occurred soon after the ZOSTAVAX (Merck) was administered he was not certain that these were a related phenomenon. All available medical records will be provided up request. Additional information is not expected.
Reaction to immunization:  Large erythematous patch distal to injection site, redness, warm to touch, blanchable, mild tenderness with palpation.
Had the shot but it keeps coming back/Suspected vaccination failure; Could this be shingles?/had the shot but it keeps coming back; Bumpy rash on my butt; Tired; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, papular rash, tiredness and sickness. On an unknown date, the outcome of the vaccination failure, papular rash, tiredness and sickness were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, papular rash, tiredness and sickness to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comment: This case was patient by a consumer via interactive digital media. The patient got a bumpy rash on his/her butt sometimes, specially if he/she was tired or sick. It took a week to go away. The reporter wanted to know if this could be shingles. The patient had the shot but shingles was coming back. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Flu like symptoms for a day. Sudden hearing loss in right ear 4/3/21. Hearing not restored. Physicians don't know the cause.
Angioedema, suspected due to ACEi -Patient admitted under the impression listed above. This resolved. Suspected trigger ACEi, also could be an expired nasal spray patient use prior the episode. Will continue 3 days of prednisone, famotidine and benadryl. Epipen prescribed if another episode of angioedema occurs. Patient stable for discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Report 2010017091 describes injection site redness and swelling in a vaccinee of unspecified age and gender who received hepatitis B vaccine (brand unspecified). Allergies and medical history were not specified. Concomitant vaccine: hepatitis A vaccine (brand unspecified) administered at the same time as hepatitis B vaccine (brand unspecified). On an unspecified date, the vaccinee received the unspecified dose of hepatitis B vaccine (brand unspecified). Subsequently, the vaccinee experienced injection site swelling and redness. As of 01/19/2001, the outcome of the events is unknown.