chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 welts on right arm, chest, stomach; all of them itch; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (2 welts on right arm, chest, stomach) and PRURITUS (all of them itch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    Concurrent medical conditions included Hypertension, Drug allergy (Allergic to Biaxin.) and Seasonal allergy. Concomitant products included LISINOPRIL, AMLODIPINE, ESTRADIOL, PANTOPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID] and FLUTICASONE for an unknown indication.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 12-Apr-2021, the patient experienced URTICARIA (2 welts on right arm, chest, stomach) and PRURITUS (all of them itch). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (2 welts on right arm, chest, stomach) and PRURITUS (all of them itch) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-075533 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075533:
A report has been received from a Health Professional concerning a 2 year old female patient. The patient's concurrent diseases included Allergic rhinitis. No medical history and concomitant medications were reported. On 16-Oct-2012, the patient received nasal FLUMIST. Dosing and frequency were not reported. It was reported that 5 children got FLUMIST and then came back in and tested positive for Flu A. This patient was tested positive for Influenza A on 23-Dec-2012. The patient treatment medication included TAMIFLU. The patient recovered from the event of tested positive for Influenza A on an unspecified date. The report was considered to be non-serious by the reporter. Summary of follow-up information received 24-Jan-2013 from medical representative. Event outcome was updated from unknown to recovered. Reporters details updated. Concomitant disease was added. County of administrator was added. Corrected report: 28-Jan-2013: Action taken was changed corrected from unknown to not applicable.
Pt stated developed 2 nodules around injection site and had itching - developed 1 day following injection. Reaction developed in R arm near PREVNAR injection site.
reports felt drowsy 2hr p/vax;that evening felt woozy;on Tues about 4AM on way to work had back pain, tingling to legs & vomited;c/o flu sx (h/a,pain,n,runny nose);no taking solid foods;
Pain at injection site, arm felt kind of sore and tingly for 1-2 hours after injection. Upper arm muscles were generally sore for the next 24 hours. The next morning I felt fatigued but it resolved by the evening.
Developed mild malaise 6 hours after injection progressing to fatigue w/ epigastric discomfort. Periodic bouts of mild nausea. Experienced nausea and epigastric pain the day after injection. Moderate fatigue approximately 24 hours after injection,  gradually subsiding, with only gastric discomfort lingering after 36 hours. This symptom subsided on day 4 after injection. Self-treated with rest, acetaminophen and famotidine as needed
Arm soreness; fatigue; arm tension when lift; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), FATIGUE (fatigue), LIMB DISCOMFORT (arm tension when lift) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (FAMOTIDINE ACID REDUCER) for Acid reflux (esophageal), MONTELUKAST SODIUM (SINGULAIR) for Asthma and Allergy, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and NIFEDIPINE for Hypertension, CHLOROTHIAZIDE SODIUM and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness), FATIGUE (fatigue), LIMB DISCOMFORT (arm tension when lift) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 06-Mar-2021, VACCINATION SITE PAIN (Arm soreness), FATIGUE (fatigue), LIMB DISCOMFORT (arm tension when lift) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Bystolic, Nifedipine, Chlorothiazide, Singulair, Breo, Famotidine.
Body aches, fatigue, headache, low back pain, low grade fever, nausea, severe left arm pain, cough, runny nose
Patient had a seizure about 4 hours after the vaccination, which lasted for about 45 seconds. Patient did not have any further episode and did not seek medical attention.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously, lot number R008203, expiration date 16-SEP-2019 (exact dose, frequency and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered vaccine was stored in the range of 15 Fahrenheit degrees (F) to 46 F (14.9 F) for 1 hour and 30 minutes and in the range of 6 F to 14 F (14.4 F) for 2 hours and 30 minutes. No previous temperature excursion was provided. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA001359:
Developed painful  headache behind eyes 1 hour after vaccine and headache has persisted 28 days. Improves with over the counter pain medication but does not resolve. No other symptoms.
Patient has not received 2nd dose of Moderna vaccine; Perpetual need to cough; Like having a bunch of cotton balls or socks on their throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Perpetual need to cough), OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE and VITAMINS NOS for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COUGH (Perpetual need to cough) and OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 21-Jan-2021, COUGH (Perpetual need to cough) and OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information reported On 16-Jun-2021: Reporter contact details and event information updated
Today is day 6 and I am still having body aches, headache, nausea and brain fog.
07:55 on 11/14/19  Influenza Seasonal Vaccine was administered. At 15:21 on 11/14/19 the patient complained of chills, body aches, and throat swelling. Temperature was 101.2 HR: 115 with O2 Sat of 98% to room air. Eyes were reddened and described as "blood shot". Throat redness and mild swelling was noted by medical staff. The patient was treated with one dose of Epi-Pen , Benadryl 50 mg. IM, and Tylenol1300 mg   at 15:22 and transported to Hospital. The patient returned at 19:45 back to his housing unit at 19:45 with a complete resolution of symptoms and in no distress. Temperature was 98.6 HR 84 BP 130/80
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent and unknown gender. On 16-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
On Monday, 3/29/2021, approximately 45 minutes after receiving the vaccine, I was feeling quite nauseous.  That lasted about 12 hours.  My arm started to become a little achy in the evening.   On Monday, 3/29/2021, approximately 6 hours after receiving the vaccine, my left arm at site of vaccine, started to swell, get hard and hot.  This lasted until the evening of Wednesday, March 31, 2021.  My arm was also very sore on the next two days after receiving the vaccine.   CONTINUED:  On Monday, 4/5/2021, upon waking up at 7:00 a.m., I experienced a massive headache on my forehead, along with heat, hardness and red splotchiness about 3 inches                         below the injection site.  It was very uncomfortable, but I did not take any pain medicine.    On Friday, April 9, 2021 the heat, hardness and swelling about 3 inches below the injection site continued.  However, the red splotchiness had now become a red band                       across my upper arm and is still continuing to current time (5:15 p.m.).
Vial which has been kept longer than its standard time frame was administered to patient.; Vial which has been kept longer than its standard time frame was administered to patient. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial which has been kept longer than its standard time frame was administered to patient.) and PRODUCT STORAGE ERROR (Vial which has been kept longer than its standard time frame was administered to patient.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial which has been kept longer than its standard time frame was administered to patient.) and PRODUCT STORAGE ERROR (Vial which has been kept longer than its standard time frame was administered to patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial which has been kept longer than its standard time frame was administered to patient.) and PRODUCT STORAGE ERROR (Vial which has been kept longer than its standard time frame was administered to patient.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care profession stated that, the vial was not expired.  No treatment information was reported.   Reporter did not allow further contact
Breakthrough case admission after 2 Janssen vaccines Janssen 3/19/21 Lot# 1805020;  Janssen 11/30/21 Lot# 213D21A
Upon returning home from doctor?s office after vaccine was administered, at 13:30 child was unable to latch for breastfeeding. By 16:00 child could latch but started to vomit after nursing. Vomiting continued through the day and night after each feeding, vomiting 3+ times after each feeding. Child developed tremors in his legs around 19:00 that would start and stop spontaneously. Parents called the doctor?s office around 21:30 and the nurse on the answering service told parents to take child to ER. Parents called the doctor on her personal line and she said to continue to monitor child but that due to the fact that he is nursing and having wet diapers there was no need to go to the ER. Symptoms are still ongoing and no treatment has been administered.
Pruritic, erythematous rash extending from injection site in L deltoid to L elbow
PATIENT HAD A SEVERE REACTION TO FIRST COVID-19 VACCINE, PT WAS TAKEN BY ABULANCE TO ER. HE STATED THAT HE TALKED TO HIS PHYSICIAN AND THAT IS WAS LIKELY NERVES/ANXIETY, HE WAS GIVEN XANAX OR ATIVAN AND TOLD TO TAKE PRIOR TO VACCINE #2. WE WERE PREPARED AS WE ARE THE SAME STAFF THAT WAS HERE WHEN HE HAD HIS FIRST REACTION. AFTER VACCINE 2 HE SEEMED OK BUT THE RPH STAYED WITH HIM INCASE OF REACTION. HE GOT PALE, SWEATY, SEEMED OK. HE THEN WENT UNCONSCIOUS, 911 WAS CALLED, HE SEEMED TO CONVULSE, AND BIT HIS CHEEK. FIRST RESPONDERS CHECKED HIM OUT, HE REFUSED TO GO TO THE ER VIA AMBULANCE. PATIENTS WIFE SAID SHE WOULD DRIVE HIM TO URGRNT CARE. 5/14/21
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "contracted trinities". Additional information: The patient reported contracted trinities after being vaccinated for Covid. It was problematic. Patient asked what help was available that subs for prednisone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccination site pain, fever, chills, fatigue, myalgia, loss of appetite. All moderate severity.
15SEp92 pt recvd vax & devel a flu-like syndrome characterized by genralized aches & pains, nausea, fever & generalized fatigue;
sore and fever all night; had sore and fever all night; This is a spontaneous report from a contactable consumer from a Pfizer-Sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 03Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore and fever all night on an unspecified date. The reporter asked if it is normal to experience. The patient second dose was scheduled on 24Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
moderate irritability alternating w/lethargy; poor feeding; tender, swollen inject site;
Previously had COVID as of January 12, 2021.  Adverse events: pain at injection site, upper shoulder pain, low grade fever (up to 99.5), headache, nausea, chills, tired and weak. The pain started in the night. Woke up around 6:30A and that is when the other symptoms started. Taking Tylenol as of 6:30A and then 12:30P. Took ibuprofen in the night. As of 3:30PM on 4/1/2021, still feeling under the weather with chills, headache, fever, pain.  Performing home care.
Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after being vaccinated and continued to get worse over a period of 6 hours. Nausea and stomach pain also present.  Diarrhea started 19 hours after being vaccinated.  Body aches and diarrhea continued for a total of around 20 hours of symptoms.
Patient received the vaccination mid morning and within 30 minutes she developed a headache with described as "a sharp pain going through my head". (this same headache occurred after anthrax #1 in May 2010 and lasted x 2 weeks). By the evening she also developed multiple bouts of watery diarrhea, nausea and intermittent vomiting. She also developed generalized muscle and joint pain, clammy skin, hot and cold sensations and fatigue. The headache continued unabated. Two days later she sought evaluation in the Medical Clinic with Dr. She was given PHENERGAN, diarrhea medication and sent home for 3 days. She also took ibuprofen and ate a "BRAT" diet. After 2 weeks the nausea, diarrhea, hot/cold sensations dissipated. But the headache continued unabated and muscle/joint pain in the lower extremities continued. Current Symptoms: Presently the patient reports she has a continuous headache that worsens with bright light and loud sounds. She also has pain in the legs from just above the ankles to above the knee caps that never resolves. Around Thanksgiving this lower extremity pain worsened, even the weight of bed sheets were intolerable. She denies numbness, tingling, spasm, fasciculation, swelling and redness of the extremities muscles and joints. She states touch or massaging the legs makes it worse as well as activity including walking. She states she can stand for only 15-20 minutes before the pain forces her to sit/lie down. Stretching and weather changes do not affect the pain level. Sometimes the pain is worse on one side than another and there is no pattern to this alternating intensity. Headache has now lasted continually for 4 months. Lower extremity pain continues also. She is unable to work and needs to be prone all the time. She is now on Workmans' Comp. All evaluation has been negative. Trials of 5 migraine prophylactic drugs have been ineffective. Patient is a civilian employee. The Vaccine Healthcare Center was consulted due to the morbidity and chronicity of sxs.
Information has been received from an office manager concerning a female patient who on an unspecified date was vaccinated intramuscularly with the first dose of GARDASIL (Lot number was unknown). Concomitant vaccine therapy included on the same day a dose of MENACTRA. It was reported that shortly after (date not reported) the patient developed mononucleosis. The manager was not sure if the GARDASIL series was completed. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient's mononucleosis was unknown. Additional information has been requested.
Employee states, "Itching all over the body for several weeks."  Indicated that this started about 2 weeks after receiving 1st covid vaccine.  She had itching from head to feet and was treating with Benadryl and Zyrtec.  She indicated that she had little welts/bruising from scratching.  She did not see a provider regarding this reaction.   2nd covid vaccine given on 6/27/22, instructed to treat with Benadryl and Zyrtec as needed and seek medical attention if this reaction develops after 2nd vaccine.
Exactly 12 hours after receiving the vaccine, I began to feel fever, Chills, systemic bodyaches and pains. Additionally is a lymph node in my left axilla swelled to the size of a baseball.
Per Pt's mother at approx. 9 pm on 5/13/09. Pt c/o- H.A.; No relief with ADVIL; 5/14/09 at 11am - Pt. still experiencing H.A. and given 1 TYLENOL by her mother with slight relief- Pt. c/o - chills, sore throat and neck ache - with pain to her Rt. leg. Mother did not seek any medical care, Pt seen here by doctor on 05/15/09;examined/eval for meningitis- WNL; encouraged Pt's mother to take her child to PMD for further evaluation. Mother states she will if child becomes ill.
3x4" red, hot to touch, tenderness around injection site on right upper thigh. Dx cellulitis treating with antibiotics and antihistamines.
hurting between shoulder and elbow; soreness in left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (hurting between shoulder and elbow) and PAIN IN EXTREMITY (soreness in left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PAIN (hurting between shoulder and elbow) and PAIN IN EXTREMITY (soreness in left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (hurting between shoulder and elbow) and PAIN IN EXTREMITY (soreness in left arm) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR with update to events, dose 2
Fever; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) negative; (11May2022) negarive; (12May2022) Positive; (13May2022) Positive; (14May2022) Positive; (15May2022) Positive; (16May2022) Positive; (03May2022) Positive, notes: started taking Paxlovid the day after tested positive for Covid. Therapeutic measures were taken as a result of covid-19. Clinical course: No other medication in 2 weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 04May2022 and stop date: 08May2022. Patient started taking Paxlovid the day after patient tested positive for Covid (day 1). Patient completed the Paxlovid course on day 5. By day 7, patient was testing negative for COVID on home antigen tests, patient remained negative on day 8 but on day 9 patient was testing positive again. On day 10/11/12/13 patient remained antigen positive  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.