chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I can not move my left arm do to the severe pain and inflammation. It has now been 10 days I went to the doctors who gave me a steroid shot to lower the inflammation and taking pain med (hopefully I will not have a reaction to the pain med). I had a fever for four days, migraine for 5 days, nauseous for 3 days, severe shoulder pain, abdominal cramps (have not had cramps in yrs.) and chills for about 5 days.
Hashimoto's Thyroiditis; had a sore in my mouth after the 2nd outbreak; lips were really dry; rash; chills; low grade fever; This is a spontaneous report from a contactable consumer (reported on herself). The female patient of an unspecified age received second dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a first dose, single for COVID-19 immunization. After the first dose on the third day, she had patchy redness on her cheek. Then she had a rash on her face from earlobe to the other earlobe. It started out as red spots that it was so bad that it welts together. It went down her neck and she had one spot that stayed on face and one spot on chest and a rash on face. After the first, she went to a dermatologist and he put her on a topical steroid cream and steroid tablet for 5 days. After she had the second vaccine, she did not have an outbreak until 2 weeks after because she still had that steroid in her system, as she believed. She had a sore in mouth after the second outbreak. It was also on her lips during my second one. Her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it had appeared only on lips. Each time she got this outbreak, she got chills (4 hours of chills) and a low grade fever. Now it was on lips and on the outer rim of lips. It was stated that she would be going to the dermatologist on the day of this report. On an unknown date, the patient had Hashimoto's Thyroiditis, which reduced her immune system. The patient had been to urgent care, to HCP, and was on third trip to the dermatologist. The outcome of the events of Hashimoto's Thyroiditis, had a sore in mouth after the second outbreak, lips were really dry, rash, chills, low grade fever was unknown.  information on about lot/batch number has been requested.
Have red bumps on chest, stomach, back, shoulders. Have a few red bumps on arms, legs, face. Bumps itch and are still present. Had sore throat, left eye began twitching and is still twitching. Not doing this previously, just had eye exam beginning of December. Not exactly sure of vaccine dates or beginning of symptoms.
This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2009, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
10 hrs p/recvd DTP began shaking duration 5-10 mins; occurred again 1AM; seen by MD 10JAN92 no problem found t102.4;
very tired; asleep for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and SOMNOLENCE (asleep for 24 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B214) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (very tired) and SOMNOLENCE (asleep for 24 hours). On 23-Apr-2021, SOMNOLENCE (asleep for 24 hours) had resolved. At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.
rash; This spontaneous report was received from a nurse and refers to a 6 month old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 2, orally, for immunisation (strength, frequency, lot# and expiration date were not reported). On the same day, the patient received diphtheria toxoid, pertussis acellular vaccine (unspecified); and poliovirus vaccine inactivated (unspecified), both for immunization (dose, strength, frequency, lot# and expiration date were not reported).      Later that day, the patient developed a rash. An appointment was made with the physician's office to address the rash, but it had resolved by the following morning. Causal relationship between the suspect therapies and the event rash was not reported.
Information has been received from an 81 year old female with no medical history or allergies who on 21-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included COUMADIN, atenolol, ezetimibe (MSD), aspirin, "ISOSORB MONO", aspirin lysine, calcium (unspecified), vitamins (unspecified) and potassium (unspecified). On 21-JAN-2008 the patient developed a rust colored mark the size of a dime about 1 to 1.5 inches below the injection site. The patient also mentioned a 3 inch in diameter circle that was red and warm. The patient said it was hot at first but the heat decreased. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Pt received 1st covid shot in left arm. Became wheezy and described feeling like he was going to pass out. Paramedics called to store. They observed pt and determined  reaction was not from a vaccine ingredient but instead a panic attack.
11pm: developed 99-100F fever; took 650mg of acetaminophen 4am: fever spiked to 103F, headache, stiff neck, optical flashes 5am: took another 650mg of acetaminophen 11am: fever reduced to 99-100F 5pm: fever gone; body temp back to 98.6F
About ten hours after the injection (8:00 am), I started feeling like I had a flu coming, by 7:30 pm I was shaking and felt really cold. I got under a blanket when I got home and drank some tea. I went to bed at 9:00 pm wearing a t shirt, sweat pants and got another blanket to put on the bed as I was so cold. By 1:00 the next day the symptoms were subsiding - I still have a pain in the arm from the shot.
Redness at site of injection, hard knot low grade fever-required MD visit. Late onset of reaction indicates possible allergy to drug.
Information has been received from a physician concerning a female teenage patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck). The physician reported that the patient developed shingles 4 times in different areas of the body after receiving the second dose of VARIVAX. The first time that the patient developed shingles was "a couple of days after the 2nd dose of varicella vaccine". The patient sought unspecified medical attention. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pruritus and incomplete course of vaccination. On an unknown date, the outcome of the pruritus and incomplete course of vaccination were unknown. It was unknown if the reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced arm itching and back itching after receiving a dose of SHINGRIX. On 19th March 2019 the patient was going to the her physician and she told that she will mention this to her physician. In March 2018, the patient got the first shot of SHINGRIX and forgot to go back for the next shot, which led to incomplete course of vaccination.
Heavy vaginal bleeding with clotting occurred at beginning of April 2021 and was followed by ectopic pregnancy that was treated at the end of April 2021. I have no risk factors for ectopic pregnancy.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28 Jun 2023, 9 doses were administered at administration site 1.  Treatment medications were not reported.  This case is for 7th patient out of 47 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: Vaccine administration date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
Severe sudden pain and swelling in upper left arm starting at injection site. Cannot move left arm due to pain. Now 3 days after injection and still cannot bend arm at elbow more than 30 deg. Seen in ED and evaluated by orthopedic surgeon who said there is nothing wrong with the shoulder  joint. But because of pain, patient cannot use arm for activities of daily living, including combing hair, driving, or lifting arm to do any other things.
Exposure to COVID-19 virus / ASYMPTOMATIC  COVID-19 virus infection Dx Medication Infusion  Reason for Visit Progress Notes Encounter Date: 8/6/2021 ? ? Signed    Patient is here for MAB Infusion O2 sats > or = 90%   Signs of potential reaction reviewed with patient. Pt wife who is also Covid pos stayed with pt due to his dementia   Tolerated IV start and MAB infusion without complication.   Pt has access to pulse oximeter and thermometer for home monitoring   Discharge instructions reviewed. Patient denies any questions
Patient received first dose of J&J vaccine and came in to get Moderna booster.  Communication we receive from corporate looked like those who got J&J would receive a full 0.5ml dose of Moderna so that is what this patient got.  Much later that evening, we learned that everyone who gets a Moderna booster gets 0.25ml with the exception of those who are immunocompromised.  Spoke to patient to inform that she got the full dose and she was very happy to have received the full dose.  She felt just fine after the shot.
Started with a headache 9 days after 1st vaccine. Next day I had headache, fever of 101.1 at the highest, aches, chills and fatigue  followed by nausea and vomiting. Symptoms lasted for 5 days and was back to work in a week.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 21Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic esophagitis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: eggplant" (unspecified if ongoing); "Known allergies: Onions" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient receive Paxlovid to treated drug ineffective, covid-19. Date of start of drug: 17May2022.
Information has been received from a physician concerning a 59 year old male who on an unspecified date was vaccinated with a 0.5 mL dose of Pneumovax 23. Subsequently the patient developed fever and flu like symptoms. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from fever and flu like symptoms. Additional information has been requested.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult other patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Immediate sensitivity reaction on lower left thigh, at site of varicella vaccine (10cm x 8cm urticarial rash). In about 10 min, pt then developed hives on face, involving eyelids, cheeks with multiple urticarial spots, darkening of oral mucosa. Treated with Be3nadryl 125 mg PO and Epinephrine 0.11mg subcutaneous injection.
Information has been received from the authors in a published literature article, referring to two adult female patients (age at vaccination between 21.5 and 23.6 years old). Relevant medical history, drug reactions/allergies and concomitant medication at the vaccination time for the patients involved were not reported. The authors aimed to identify and describe a cohort of young women from a single institution in a high incidence region. During this study they identify that only two participants had received one or more doses of the HPV vaccine for prophylaxis but none reported completing the series (strength, route, dosage schedule, lot number and expiration date were not reported). It was not specified if the patients received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown).
PATIENT HAD FEVER AND FEVER BLISTERS ON LIPS THAT STARTED THE NEXT DAY, LASTED FOR A COUPLE OF DAYS.
have not received the 2nd shot. It has been 4 months since the first.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (have not received the 2nd shot. It has been 4 months since the first.) 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 PRODUCT DOSE OMISSION ISSUE (have not received the 2nd shot. It has been 4 months since the first.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received the 2nd shot. It has been 4 months since the first.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
3" x 3" red, hard, tender, itchy, hot raised area 1" distal to injection site. Treated with Tylenol and ice.  Lump still present on 10/15/2018, however no itchiness, no temperature differentiation and lessened swelling.
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of GARDASIL 9 (Lot # K026247 Expiration date: 19-JAN-2017), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Initial pain in arm; in the evening, starting around 9 hours post-injection (8 PM), began to have other aches & pains: chest, back, joints. After going to bed, began to have chills, more aches (legs), fever, headache. Woke around midnight (13 hours post-injection) and noticed nasal congestion, more intense fever, and legs and feet felt "heavy" when walking; unable to get back to sleep (despite staying in bed). Took temperature around 3:45 AM (almost 17 hours post injection) and temperature was 101.1. Took NyQuil, went back to bed, fell asleep around 4 AM. Woke after an hour, but stayed in bed and went back to sleep. Got up around 8 AM (21 hours post-injection), still achy but not as much. Tired. No fever. Mostly recovered at this point.
This spontaneous report as received from a pharmacist and a physician refers to a 72 year old female patient. While her medical history was unknown, her historical drug usage included XOLAIR and her concurrent conditions included hypertension, a possibility of a rheumatic issue and hypercholesterolaemia. Meanwhile, her concomitant therapies included hydroxychloroquine sulfate, simvastatin (manufacturer unknown), BYSTOLIC and doxazosin. On 23-MAR-2017, the patient was vaccinated with ZOSTAVAX (which had a lot # of M035693 with an expiration date of 07-NOV-2017), subcutaneously, in the right arm, for prophylaxis. The reporter described the anatomical site to be the fatty area 2 cm above the elbow on the dorsal side. Aside from this, the patient was also administered a sterile diluent (manufacturer unknown) on an unknown date (the strength, dose, frequency, route of administration, and indication were unknown). Subsequently, on 27-MAR-2017, the patient paid her physician a visit regarding some unspecified complaints. She was diagnosed with cellulitis at the site of injection. The site was described to be warm with redness. It was unknown whether any treatment had been administered although, the physician had provided a prescription for an EPIPEN. The injection site cellulitis was inferred to be resolving since the  physician stated that the site was smaller than it what it had been before. No causal relationship was provided between the event and the two suspect therapies. Additional information has been requested.