chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal symptoms of thrush/yeast thrush infection in mouth; Throat irritation; Itching in mouth; Crotch area is red; Irritation down in crotch area/down in crotch area; Thrush infection down in crotch area; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red) and GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red), GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area), CANDIDA INFECTION (Thrush infection down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FLUCONAZOLE for Adverse event, at a dose of 1 tablet once a day for 10 days and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red), GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area), CANDIDA INFECTION (Thrush infection down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Treatment information included fungal medication for months, on and off. Patient took Famotidine to treat throat irritation and itching in mouth.  Patient experienced the symptoms after the first dose which got bad after receiving the second dose of vaccination. Consumer did state he did not had these problems prior to vaccination.   This case was linked to MOD-2021-369271 (Patient Link).
rash on arm; swollen itchy band; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm), VACCINATION SITE SWELLING (swollen itchy band), FATIGUE (tiredness) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (headache). On 07-Apr-2021, the patient experienced RASH (rash on arm) and VACCINATION SITE SWELLING (swollen itchy band). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency and DOXYCYCLINE for Rash, at an unspecified dose and frequency. On 01-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, RASH (rash on arm), VACCINATION SITE SWELLING (swollen itchy band) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included Statin. Treatment included ice for rash.
my stomach began cramping; migraine; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date at the age of 50-year-old as single dose for COVID-19 immunization. Medical history was not reported. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was none. First does within 15 min of the vaccine, the patient's stomach began cramping. He had a migraine with 24 hrs of the vaccine that lasted 24 hrs. The patient received the second dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and had extreme fatigue for 2 weeks. Now almost 3 weeks out from the 2nd shot he have Covid fog. The events resulted in disability or permanent damage. No treatment was received. The outcome of stomach cramps was unknown. The outcome of other event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever, swollen lymph node under arm, extreme fatigue, headache and nausea.
Headache, Fever, sore arm, tiredness.  Fever only breaking ~3:30 AM Monday Morning (8/9/2021).
Right arm red and warm to touch (1/14/03) advised to apply cool packs - no cool packs had been applied. Asked to call back or if any streaks worsens to see MD. 1-15-03 1pm came by office less redness to site but continued swelling toward underarm. Noted cat scratches on arm. Advised to take child to pediatrician. 1/15/03Mother stated MD said to continue with cool packs and give Benadryl.
Fever, aches, lethargy immediately afterwards for two days?.  AND SIGNIFICANT GROSS HEMATURIA that began within two weeks of third shot and continues daily and  presently (1/26/2023)
Swelling at injection site, lymph nodes are swollen. Being monitored by her oncologist but no treatment (per nurse).
Started 09/6/2021 PM excessive sneezing, nasal congestion, chills, fever and head ache that progressively worsen   09/08/2021 tela health visit with doctor then had a drive up test for COVID negative, family members and friend was testing positive and spoke with her physician for a re- test recommended, 5 days later 09/15/2021 COVID tested positive.
lack of energy/energy zapped/totally wiped out; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration on 19Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included pregnancy from an unknown date and unknown if ongoing, and illness from an unknown date and unknown if ongoing. It was reported that the patient took no prescriptions on a daily basis. The patient had never had a flu shot and never got sick except pregnancy. Concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: not reported) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunisation. On 25Feb2021, 6 days after the second Covid vaccination, the patient experienced energy zapped. On day 6 after the second Covid vaccination, she felt totally wiped out which lasted a couple of days. The patient was active, doing Zumba 3 times a week. Walked 4 miles 3 times a week. Cross the finish line of 1 half marathon a year. Run/walk it. The patient thought her immune system seemed normally good was there any reason for her reaction to the second vaccination. Energy zapped 6 days after the 2nd Covid vaccination which she received on 19Feb2021. She felt totally wiped out which lasted a couple of days. But then she did not get her normal energy back until the middle of Aug2021. That was 6 months. The patient was worried about what might happen if she get the 3rd shot and not wanting to experience the lack of energy again or whatever else might happen. The patient mentioned her next 1/2 marathon was on 30Apr2022. She was afraid if she would not have the energy to train and complete this event, which was very important to her. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On an unknown day, an unspecified number of patients received doses of ROTATEQ (lot # L008574, expiration date 22-NOV-2016; lot# L013188, expiration date 02-NOV-2016; lot# K020182, expiration date 26-JUN-2016; lot# K008139, expiration date 15-APR-2016; dose, frequency and indication were not reported), orally, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient immunized with Varivax vaccine on 3/4/09.  Over the next 48 hours, she developed redness and warmth at injection site, and surrounding area measuring 13cm.x14cm. Referred to Occ. Med. MD.  Diagnosis- Cellulitis secondary to recent vaccination.  Treated with Keflex 500 mg. TID, with reassessment in 72 hours.  Pt. fully recovered.
Syncopal episode several minutes after shots. Pt did not eat breakfast that morning, had little to drink that morning. Had previous stress over getting shots. Pt monitored x 1 hour, VSS, recovered completely. Phone plus 2-3 hrs later within normal.
13 years old pt. was given pfizer pediatric instead of pfizer (12 years and older) vaccine
Moderna COVID-19 Vaccine EUA Red, inflamed, hot-to-the-touch blotch has appeared surrounding the injection site. About an inch and a half in diameter. Appearance started 9-10 days post-injection. Patient also running a fever of 100.2. I'm reporting immediately so no treatment/outcomes yet.
Aches in body similar to flu like symptoms. 2 day headache Tiredness.
Patient experienced fatigue, lack of appetite on the day after the vaccine was administered. Redness and inflammation around arm and "almost hive-like inflammation" at injections site lasting approximately 5 to 6 days. Severe nerve pain in toes for a couple days following vaccination. All symptoms cleared up per patient.
Adverse event began approximately 2 hours after vaccine was given.  Patient stated that her body and face became really hot and red.  She also felt that her pulse was racing.  She had some numbness on her left side.  All had been resolved by the next day. 11/3/09 Medical records received from OB from 5/09 to 10/28/09. OB records received. Noted pt had H1N1 vaccine. Normal pregnancy progression.
Patient received IMZ on 11/09/20 and called pharmacy on 01/12/21 to report adverse event.  Patient states a little swelling and sore on first night as expected.  Pain/soreness and affected range of motion has continued.  Patient did not seek medical treatment.  Has taken Tylenol and used heat as self treatment. Patient has a physical with primary provider on 01/20/21.  Patient states it is getting better.
This spontaneous report as received from a mother of the patient refers to a 18 year old female patient with drug allergy to penicillin (had hands and feet swell) and no medical history. On 19-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route and indication were not provided). Concomitant therapies included ORTHO-NOVUM 7/7/7. Within an hour after the patient received the shot she experienced severe abdominal pain. The patient was taken to the emergency room but was not admitted overnight. The patient did not receive the treatment for AE. Computerized axial tomography (CAT) scan showed lymph node on her appendix was inflamed on an unspecified date in 2013. The hospital believed she experienced an allergic reaction to the vaccine and she was recommended to not get the second or third doses of GARDASIL. On 20-JUN-2013, the patient was recovered from 'allergic reaction to the vaccine" and severe abdominal pain. Outcome of "lymph node on her appendix was inflamed" was unknown. Additional information has been requested.
Pt presented for COVID vaccine after being cleared by PCP this morning. Approx. 5 mins after injection pt c/o palms sweaty/lightheadedness. BP: 122/81, P: 75, RR: 18 non lab, SaO2: 98%, ice pack to back of neck and pts head down, then assisted onto stretcher. 1036: drank apple juice, feeling a "little fuzzy" but better. 1038: BP: 114/78, P: 76, RR: 16, SaO2: 97%. 1049: C/o R hand sweaty/tingling which is similar to her aura prior to seizures, BP: 127/78, P: 68, RR: 16, SaO2: 97% taken to ED via stretcher, assigned to bed 6, placed on cardiac monitor and pulse ox, no changes noted. Pt still symptomatic "off and on". Stayed with pt until report given to ED nurse. ED visit, Monitoring at vaccine site.
2 episodes of unresponsiveness lasting 1 1/2min each 1st @ 1030AM;pt lethargic afterwards;
11 BY 9 CM. CIRCULAR, RED, INDURATED NON-TENDED LEFT ANTERIOR THIGH.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 27-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
DIARRHEA; ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, not reported, once a total administered, start therapy date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, and aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and aches was not reported. This report was non-serious.
-Rash similar to poison oak or chicken pox. -Swelling + redness -both legs + some arm areas.   After patient saw MD on 9/5/19 it was determined the pt had poison oak + was prescribed Medrol + Lidex cream. Pharmacy still wanted to report the adverse reaction in case there was a link.
forgetting simple things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "forgetting simple things".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021234124 Same reporter and drug, similar event, different patient
Patient here for covid vaccine, had no problems with first dose.  Approximately 10 minutes after vaccine today, complaints of scratchy throat, numbness to tongue and pain/redness to injection site, now blotchy spots to chest. Patient taken to triage, given Benadryl 50 mg and monitored for additional 50 minutes until symptoms resolved.  Husband called to take  her home.  VSS, monitored every 5-10 minutes.
Patient vaccinated on Sunday 9/5/2021. She reported to the pharmacy on 9/7/2021 she has numbness in her right thumb and index fingers that started on Monday 9/6/2021 (the day after she received the second dose of Pfizer COVID-19 vaccine). Patient is unsure if it is related to the vaccine. Patient will monitor symptoms and seek medical attention if symptoms don't subside.
Meningococcal B vaccine was inadvertently administered to under age 16 in a healthy child.
Client to clinic to receive the covid -19 vaccine pfizer. Client received Moderna at visit. Sat in lobby for 15 minutes per protocol and no adverse reactions noted.
Information has been received from a physician concerning a female who began the vaccination series at "2 months of age" (date not reported) with Rotateq. It was reported that one month after receiving the third dose of the vaccine (date not reported) she developed intussusception and was hospitalized. Diagnostics were not reported. The intussusception was treated with a barium enema. At the time of this report, it was reported that the patient had recovered. Intussusception was considered to be life threatening and an other important medical event by the reporter. Additional information has been requested.
No additional AE reported; Customer calls and reports a temperature excursion. She reports that some of the vaccines were administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021826, expiration date 25-JUN-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).       Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.3 degrees of Fahrenheit for 9 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000657: US-009507513-2108USA000620:
mom reported to clinic pt had a fever 102 x 3 days; beginning 19JUN93 to 22JUN93; pt taken to MD on 23JUN93 & dx w/measles; dx w/roseola;
starting 1 day after the injection, chills without a fever x 2 days starting 1 day after the injection, general muscle soreness x 6 weeks starting 6 weeks after the 2nd injection, an unusual sinus/allergy URI  starting with sneezing, runny nose, nasal congestion lasting 5 days, then significant sinus drainage lasting 10 days
Red itchy blotch approximately 2 inches under injection site.  Started to appear about 4 days after the vaccine, and blotch is increasing in size.  Approximately 8 cm in length and 6 cm in height.  Appears warmer than nonaffected parts of my arm.
severe left arm pain, severe left neck pain (lasting several days but less severe after 24 hours), severe headache, severe generalized aches and pains lasting 24-36 hours.
I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 08/13/2022. I contacted my doctor and got a prescription for PAXLOVID. I was only able to take it for three days as I had a reaction with my other medication. On 12/03/2022 I was diagnosed with the flu. I contacted my doctor and got a prescription TAMIFLU which was wonderful. On 12/05/2022 my asthma flared up. On 01/01/2023, I had a bad cold, and I went into another asthma flare up which lasted into 02/2023. I finally started feeling better in 03/2023. As of today, I have fatigue from having COVID-19.
The patient began itching all over especially his chest, back and hands. There was no rash or swelling noted by the mother. There was no redness or swelling at the injection site. The patient denies headache, fever, nausea, vomiting, diarrhea, etc. The patient had Lidocaine with an ingrown toenail removed on 07/23/2001.
pain in injection site; Felt Nauseas; Felt Dizzy; had the runs; woke up with a slight headache on the right side of head; pain in the middle of her chest radiating to right axillary side of chest / When she inhales deeply, she experiences pain in her chest; A spontaneous report was received from a pharmacist concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in injection site, felt nauseas, felt dizzy, had the runs, woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of chest/When she inhales deeply, she experiences pain in her chest.    The patient's medical history included hysterectomy, myomectomy, IBS, anxiety, depression, partial liver removal due to hemangiomas, 2 lumps removed from left breast and melanoma on the abdomen. Concomitant medications reported included duloxetine hydrochloride, progesterone, dicycloverine hydrochloride, metoprolol succinate, metformin, probiotics nos and gabapentin.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Dec 2020, during vaccine administration the patient experienced pain at injection site. She went back to home and when in home she felt nauseas, dizzy and she had runs. The patient was not sure if this was because she hadn't eaten. The patient took a nap and woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of her chest. When she inhaled deeply, she experienced pain in her chest. The patient was not sure if her chest pain was muscular. Treatment for the event included acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, experienced pain in injection site, felt nauseas, felt dizzy, had the runs, woke up with a slight headache on the right side of head and pain in the middle of her chest radiating to right axillary side of chest / When she inhales deeply, she experiences pain in her chest  was not provided.; Reporter's Comments: This case concerns a 48 year old female with medical history of hysterectomy, myomectomy, IBS, anxiety, depression, liver hemangiomas, left breast lumps and melanoma, who experienced listed nonserious events of injection site pain, nausea, headache and unlisted nonserious events of chest pain, dizziness, diarrhea, and respiration abnormal, all occurring after mRNA-1273 administration to the right arm on 23-Dec-2020.  Event duration and outcome were not reported for any of the events. Based on the current available information and temporal association beteeen the use of the product and the start date of the events, a causal relationship cannot be excluded.