chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 month old female patient adopted from another country who has tinea corporas and a mild developmental delay, who on 5/23/2005 was vaccinated IM with a first dose of varicella virus vaccine live (lot 647763/0191P) and on 6/10/2005 at approximately 17:00 she developed a diffuse rash, which started in the neck area and worked it's way up to the scalp area and down the body. There was no illness at the time of vaccination. The physician reported that there were some very small vesicles, one of which he was able to pop and scrape if needed. The patient was treated with topical econazole 1% and multivitamin with fluoride. A specimen was collected on an unspecified date (approximately May 2005 for PCR analysis and the PCR results showed positive varicella but it was unable to be typed. Therefore it is unknown whether the varicella was wild type or vaccine type. It was noted that the patient did not have adverse events following prior vaccination. There was no product quality complaint reported. The patient recovered on an unspecified date. No additional information has been requested.
This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011735: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19 January 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The pharmacist was calling to report that a husband and wife had dose 1 of Shingrix given on January 19, 2023. She stated they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered. The Shingrix vials that the patient brought in on the day reporting to be given had an expiration date of October 12, 2023, batch number 5592T, so they were not administered. They did not get dose 2 yet and pharmacy was asking for replacement of expired Shingrix (2 full doses).  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023150326:2 of 2 report
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Occipital neuralgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim", notes: known allergies: Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date was 15Dec2022 and stop date was 19Dec2022. Clinical course: Vaccine lot unknown reason was Not available/provided to reporter at the time of report completion.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea 10 days post vaccination; pain in joints; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), DIARRHOEA (diarrhea 10 days post vaccination) and ARTHRALGIA (pain in joints) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1805031) for COVID-19 vaccination.     No medical History information was reported.     On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced DIARRHOEA (diarrhea 10 days post vaccination) and ARTHRALGIA (pain in joints). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) had resolved, DIARRHOEA (diarrhea 10 days post vaccination) outcome was unknown and ARTHRALGIA (pain in joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via FDA VAERS (Reference number: 440362) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), DIARRHOEA (diarrhea 10 days post vaccination) and ARTHRALGIA (pain in joints) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1805031) for COVID-19 vaccination.     No medical History information was reported.     On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced DIARRHOEA (diarrhea 10 days post vaccination) and ARTHRALGIA (pain in joints). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) had resolved, DIARRHOEA (diarrhea 10 days post vaccination) outcome was unknown and ARTHRALGIA (pain in joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
red rash. It started breaking out at the top of knees, going to the top of legs.; itchy; redness / red welts; swell; Redness; broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell) and ERYTHEMA (Redness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091DZ1A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell), ERYTHEMA (Redness) and RASH (broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of). The patient was treated with LORATADINE for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency; TRIAMCINOLONE (topical) for Adverse event, at a dose of 0.1 percent and CEPHALEXIN [CEFALEXIN] on 08-Nov-2021 for Adverse event, at a dose of 500 milligram every six hours. At the time of the report, RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell), ERYTHEMA (Redness) and RASH (broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of) had not resolved.            Patient didn't had a problem with 1st dose vaccine. Symptoms started with a week and a half later after 2nd dose.  No concomitant medication were given. Patient stated that she would not take a booster
patient had his flu shot since the 80's (military). Only had the flu 2 times. Only hospitalized once.; Initial information received on 05-Dec-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an 80's (military) male patient who had the flu 2 times. Only hospitalized once (influenza), while he was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient who had the flu 2 times. Only hospitalized (seriousness) once (influenza)  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who had flu after vaccination with Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication, laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Rash all over body when . persists to this day (4/20/22). A fleeting nature: individual lesions typically last for minutes, then subsides. Cholinergic, cold urticaria, exercise-induced, solar,  vibratory, and delayed-pressure urticaria/angioedema.
She said she woke up 09/03/2021 0100 with severe nausea, dizziness.  she stood up to go to the bathroom and passed out.  She said her arms felt like pins and needles were in them
Right arm injection site with large X erythematous reaction. Slight tenderness, positive blanching of body skin color. Flu-like sxs with body aches, fever, chills.
Brain fog, SOB, lightheadedness, dizziness, cough, chills, and weakness that lasts for 2 days. It's like having COVID symptoms every couple of weeks without losing taste. It keeps me out of work a lot lately.
Chills, Fever, Muscle aches, nausea/vomiting, fatigue
Received TD immunization.  within 2-3 minutes, head rolled back, eyes dilated, became unresponsive.  Had tonic/clonic seizure.  No wheezing, no rash.  Spontaneous respirations. The discharge summary received on 2/19/04 states hypotension, tachycardia and tremor.
Red rash at site of injection, lasting 5-6 days; A spontaneous report was received from a consumer concerning a 39-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red rash at site of injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced the event red rash at site of injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, red rash at site of injection was resolved in 5-6 days.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever 102.5, headache, light sensitivity for 48 hours.  Motrin and Tylenol given during this time.
Information has been received from a pharmacist concerning an about 28 year old female who was vaccinated with the second dose of MMR II (0.5ml, subcutaneous injection, lot# and site of administration not reported) last month.  The patient had a negative titer to one of the components of MMR II (unspecified which component) by the titer taken about a week ago.  Unspecified medical attention was sought by the patient.  The outcome of the patient was unknown.  Additional information has been requested.
MS relapse; Flu-like symptoms; Crawling/could barely walk with the cane; Tired/ very fatigue; Pain began in both legs, mostly my right leg but was severe in left leg also; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 26Feb2021 12:45 (Lot Number: EL3302) as single dose for COVID-19 immunisation. Medical history included Hashimoto's Thyroiditis; Multiple Sclerosis; Gluten Sensitive. The patient was not pregnant at time of vaccination. Concomitant medications included Armour Thyroid, low dose Aspirin and Vitamins (received within 2 weeks of vaccination). Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 29Jan2021 11:00 (Lot Number: EK4176/6022879) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Benadryl and experienced allergies. The patient, after receiving the vaccine, felt tired and had flu-like symptoms. she got into bed within 2 hours+ over the course of the next 48 hours she was very fatigue and the SEVERE pain began in both legs, mostly her right leg but was severe in left leg also. She eventually contacted 911 and was brought to ER. They did an ultrasound of her right leg and X-ray, found nothing and released her. The pain was still excruciating and she could barely walk with the cane they gave her and brace. The next day she was frozen in bed and contacted 911 and the ambulance took her, per her request to a different hospital. She requested a consult from a neurologist because she feared that she was having a MS relapse which was indeed the case. She was released after being given a percocet and told she can go to a neurologist on her own. The reason why this occurred was being investigated by the hospital. On day 3 Adult Protection was called because the lovely Social Worker in her building found out she was crawling. Adverse events started at 13:00 on 28Feb2021, and they resulted in "Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care". The patient was hospitalized for 2 days. The treatment for events included pain medication and assistance with personal care. The patient did not diagnose with COVID-19 prior to vaccination but she tested it post vaccination with not provided result. Events outcome was recovering.
I am post-menopausal and haven't had a menstrual period in 8 years 3 months (May, 2013).  In August 2021, I had break-through bleeding that lasted 5 days.  In September, it happened again.  I went to see the gynecologist and he performed a D&C with a hysteroscopy.  He found nothing and the biopsy was benign.  I got a period again on November 3, even stronger.  I had my hormones tested via a blood test and saliva test and the results came back within range with my progesterone being a bit low.  The doctor told me that the supplements that I take would have nothing to do with the bleeding.  My gynecologist told me point blank that he had no idea why I am bleeding.  When I mentioned that I read an article about post-menopausal women having break-through bleeding, Dr. said the Covid 19 vaccine can be the reason why since all tests were normal. I got a period again on November 29.
Provider ordered a MMR and VARIVAX, however what was given was a PROQUAD and VARIVAX. Patient rec'd more than double the dose of varicella. We have tried to reach dad 4 times, he is not returning our calls. We wanted him to give the child ibuprofen and watch for febrile seizures.
Unusual side effect- Severe itching and a red blotch at the vaccination site about one week after the first vaccination. Lasting about  4-5 days; Other normal side effects were fatigue, chills and headache the day after the first vaccination
Rash, hives, wheals, flushed. Benedryl 25mg at 10:18am. benedryl 25mg 10:32 am.
Woke up with pain in injection site. Upon examination found ping pong ball sized hard lump and injection site with redness and warmth to the touch. Placed a call with physician who dismissed all symptoms and advised to apply cold packs and administer Tylenol. Following day lump doubled in size and was about 3.5 inches in diameter and about the size of a goofball. Redness had dramatically increased as well as tenderness and patient could not put weight on leg. Injection site was still extremely sore and patient will not allow it to be touched. Called nurse advice line and was advised to continue to monitor patient for infection/fever/worsening symptoms and keep same route of Tylenol and ice packs. Three days later and the redness has subsided a bit, but swelling is still noticeable and pain isn't as significant.
Expired dose stored in refrigerator/ administered expired dose to the patient; Patient received expired dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Expired dose stored in refrigerator/ administered expired dose to the patient) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     The previous history of COVID-19 vaccination was unavailable.     In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired dose stored in refrigerator/ administered expired dose to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Expired dose stored in refrigerator/ administered expired dose to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received second booster dose.  The date when the vial was initially stored in the refrigerator was the same date that the dose was administered. The vial did not undergo any temperature excursions. The pharmacist thought the expiration date was 2069, like it was printed on the vial but the expiry date was 29-Apr-2022.  Treatment information was not provided by the reporter.
This prospective pregnancy case was reported by a consumer and described the occurrence of influenza symptoms in a female subject aged between 30 and 39 years old who was vaccinated with Flu vaccine in 2004 (not pregnant at the time) and BOOSTRIX (GlaxoSmithKline) while pregnant in 2011. A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism. Concurrent medications included Levothyroxine. It was reported that on an unspecified date in 2004, the subject received a flu shot (unknown manufacturer) and experienced mild flu like symptoms the next day. The outcome of the event was not provided. Later, on 4 May 2011 at 09:30 (at approximately two weeks gestation - unknown by the subject at the time) the subject received 1st dose of BOOSTRIX in the left arm. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period was not provided. The subject reported that her baby was due sometime in February 2012, but reported that she would not have a firm due date until her next appointment (unknown date). The subject was 13 weeks pregnant at the time of reporting.
About 52 hours after vaccine (2 days and a few hours) his neck started to ache.  About 6:30 pm the evening of the 7th.  The next morning ( July 8th) his neck still ached and we used a heating pad.  No fever at this point.  Then about 7:30 p.m. the evening of the 8th he complained of a headache, neck still aching and had a fever of 101.5  (this is the first fever we've recorded/known of).
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On 07-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II, (strength, route of administration, frequency and dose were not reported), lot # L003859 and expiration date 05-FEB-2017 for prophylaxis. Neither an adverse effect nor a product quality complaint were involved. Additional information has been requested.
Nausea, vomiting, headache, muscle aches, fatigue 4+ dayd
Right arm started hurting about 5 hours after the PPSV23 shot. Felt as if she couldn't move her arm. Called local ER and was advised to take OTC pain meds overnight and follow up with call to clinic in the morning. Called the clinic in the morning as she felt the arm was not improved. Came into the clinic for an injection of ketorolac 30mg to see if that would help her pain. She also felt as if her kidneys on the right side hurt. She awoke the next morning and said that she had blood in her urine. Went into the clinic for a visit and had a urine sample run witch was negative for infection and gross hematuria. She reports that the next morning the blood in urine was gone. A few days later she said that she took off her fingernail polish and noticed that her nail beds were "more white" than usual and feels this is related to the shot. She also reports that she had a "flair of her arthritis in her thumb joints on both sides" after the shot. States that currently her arm is "better, but still bothers her." Says that she has been going to the chiropractor to help with the side effects.