chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received a Moderna COVID19 vaccine bivalent as a second dose,; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215k22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 09-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,).    Concomitant products were not provided. Treatment medication were not reported.  Patient's 1st dose was Moderna COVID19 vaccine monovalent on 09 Dec 2022 with lot AS1412B.
Vial's use by date was 4/22/22 and the vaccine was administered 5/3/22. No adverse reactions reported
Information has been received from a physician concerning a 15 month old male with no past medical history who on 12-JUN-2007 was vaccinated with the first dose of 2 ml oral Rotateq (Lot # 656187/1237F). Concomitant therapy included unspecified vaccinations and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 12-JUN-2007, the 15 month old was inadvertently administered first dose of Rotateq. On 12-JUN-2007, the patient was a little fussy and gassy. Additional information has been requested.
12/28/10 - 2mo PE. DTaP given LL. 1/11/11 - Hib, PREVNAR > LL. 2/25/11 - DTaP given RL. 2/25/11 - punch incision - "not a significant amount of purulence drained". No growth after 24 hours on C/S.
SWELLING OF INJECTION SITE WITH PRURITUS. SEEN THE NEXT DAY, RECOMMENDED COLD COMPRESS AND BENARYL 25 MG Q 6-8 HOURS PRN SCRATCHING.
Pt vaccinated with DTP/OPV day after developed fever of 102.5, fever occurred on & off for 2 days.
ABOUT AN HOUR AFTER THE SHOT, TIRED AND WEAK. ARM SORE.  NEXT DAY WEAK, DIZZY, COULDN'T GET FULL BREATH....NEEDED BREATHING TREATMENTS ALL DAY, HARD TO LIFT ARM, TRIED TO WALK BUT FAINTED AND CRASHED INTO A WALL.
low fever (100.4); whole body aches; muscle spams; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 28Apr2021 at 10:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included cerebral palsy, asthma, anxiety disorder, processing delay and kidney disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), loratadine (MANUFACTURER UNKNOWN), potassium chloride (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and fish oil/ vitamin e nos (OMEGA 3); all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 as a single dose for COVID-19 immunisation. On 29Apr2021 at 02:00, the patient experienced low fever (100.4), whole-body aches and muscle spasms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low fever (100.4), whole-body aches and muscle spasms were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from registered nurse concerning a 42 year old female nurse who was vaccinated with a second dose of ATTENUVAX vaccine (Enders-Edmonton) (Lot# 652338/0974R). Subsequently the patient's measles titer tested negative. No other information was provided. No product quality complaint was involved. Additional information  has been requested.
Moderna COVID-19  Achiness in joints.  Slight headache. Sweating
1/13/21: received second dose of COVID-19 vaccine. One hour later experienced sensation of arm numbness, resolved within hours. Later in evening experienced a sensation of burning in entire right arm.  1/14/21: woke at 2 a.m. with sensations of shortness of breath. At 5:30am developed muscle spasms in form of twitches in right arm and diffuse muscle discomfort. Additionally describes chest pain in substernal location with radiation to right rib cage. Chest pain reproduced and accentuated by direct pressure. Developed fever of 99.9 degrees and was turned away when going to work. Returned home and recorded temperature slightly above 100 degrees.  1/14/21: experienced continued muscle discomfort and right arm twitches. Remains short of breath but seems to be improving.  1/15/21:  continued complaints of chest pain radiating from middle of chest to right side, continued shortness of breath, and whole body pain.
Had shot on AM of 31st.  First symptoms on Aug 3 in evening.  Noticed itching & rash on chest-back-legs.  No other symptoms.  Has been treating with BENADRYL & topical CALADRYL with some.  Client has recently returned from a 1 week vacation (family reunion). Her rash is diffuse and reddish-very itchy.
This spontaneous report was received from an employee at pharmaceutical company who came across an online news article on their social media news feed and refers to a male patient of unknown age. The article from News Network and was posted 29-MAY2017. The patient's medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (manufacturer not reported). The article indicated that hundreds of thousands of dollars were awarded to the patient, whose parents described how MMR vaccinations caused a "severe and debilitating injury to his brain, diagnosed as Autism Spectrum Disorder (ASD)". The outcome of the event was not provided. Upon internal review, autism spectrum disorder was considered medically significant. This is one of several report from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA012166.
Patient did not come back to clinic or call us about reaction.  Patient was in the clinic today for a different vaccine and reported swelling  at injection site and a mild rash lasting 4 days after last vaccination.
Within 24 hours, the pt developed an injection site reaction characterized by "severe" pain, swelling, redness, and warmth. The pt self-medicated with Tylenol, and applications of ice without relief. The physician prescribed Benadryl, this also did not provide relief.
CHIEF COMPLAINT:   called EMS for general malaise, nausea, diarrhea and loss of appetite   HISTORY OF PRESENT ILLNESS:     74-year-old female comes to ER for evaluation of generalized malaise and abdominal pain.  Tested positive for COVID-19 several days ago and she was symptomatic approximately 3 days ago.  Patient describes moderate URI-like symptoms with runny nose sore throat generalized body aches.  Patient was concerned about the nausea and wanted to come to the ER to be evaluated.  No history of intra-abdominal surgeries.  Her nausea has had minimal at this time and also her abdominal pain is at a minimal at this time.  REVIEW OF SYSTEMS:     General: Denies unusual wt loss/gain Eyes: Denies pain or photophobia. No visual changes. HEENT: Denies ear pain or loss of hearing. CV: Denies chest pain or palpitation Resp:Denies production of phlegm. Reports no PND or orthopnea. GI: . Is not aware of any hematemesis, hematochezia, or melena. Has not experienced constipation, loose stools or incontinence. GU: Denies hematuria, dysuria, urgency, frequency, or incontinence. Denies vaginal discharge, bleeding or pregnancy. Neuro: No reported syncope, dizziness, or any focal numbness or weakness. Denies headaches or stiff neck. MS: Denies any back, neck or extremity pain. Also denies any abnormal swelling. Skin: No itching, rashes, or unusual sweating.       Remainder of systems reviewed and are negative.
23AUG 1230 recvd DTP; sz 1830, taken to Hosp; dx UTI poss related to Pertussis vax;
Information has been received from a LPN concerning a 52 yr old white female food service worker with breast cancer, anemia, high blood pressure, sjogren's syndrome and iodine and percodan allergies, who on 11Nov04 at 09:00AM, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. On 12Nov04 at 10:00AM, the pt developed swelling, redness and pain at site, 8"x8".  It was reported that the pt was treated with diphenhydramine hydrochloride (Benadryl), ice packs, and cetirizine hydrochloride (Zyrtec) and that the pt recovered on an unspecified date. No additional information is expected.
Patient reports experiencing fatigue, joint pain, aches, fever after her most recent Moderna shot administed on 11/13/2023, as well as after her previous four Moderna shots. Patient reports these symptoms have resolved.  However, she also reports feeling a warm itchy lump around the injection site that has persisted until today 11/17/2023 and has been using benadryl to help her sleep at night.  Advised the patient to use benadryl cream during the day, to continue with benadryl oral tablets at night, and to notify her dr on Monday if her condition persists or worsens.
5 minutes post vax, pt had jerking of body and limbs for 5 - 6 seconds. Physician rules it was a fainting episode.
Around 5pm I noticed some slight body aches, joint pain, and soreness/tenderness at the injection site.  Around 6pm I started to feel fatigued. Around 9pm, I started having diarrhea.
Patient complained that he  still has  sharp  pain at sight of injection of  Spikevax  vaccine which he had few weeks ago  . He mentioned it is not shoulder just at sight of injection( specially at night). He  wanted to see his Dr which I suggested too.
body/muscle aches, fever - similar to flu for about 36 hours. red reaction area ( about 2" X 3") on arm just below injection site
Patient presents to ED 10/11 for Covid positive pneumonia, weakness, fatigue, cough, and diarrhea. She states that she was diagnosed with Covid last Thursday.  Admits to productive cough, fatigue, mild shortness of breath and diarrhea. Denies chest pain, palpitations, syncope, nausea or vomiting. He has received both doses of the Covid vaccine.  PMH Type 2 Diabetes Mellitus on home insulin, Stage 3 CKD, Hyperlipidemia, Depression, and Multiple Sclerosis.
A couple days after my first dose, I experienced intermittent numbness and tingling in my lips (no swelling). Each episode lasted for anywhere from 30 seconds to 2 minutes. This lasted for about 4 days. Additionally, about 4 days after my first dose, I also woke up with a red itchy rash under my left eye.
Patient received 2nd dose of Moderna COVID-19 vaccination on 3/10. Husband reported AMS and temp starting 3/11 at 0530 and that she was in a daze and staring into space. Husband also reported that her temperature was elevated to 105F while at home. She was brought in by EMS and had a temperature of 101.5F and a BP of162/75.
Information has been received from a pharmacist and the patient referring to a 59 year old female patient with diverticulitis and allergy to nickel. In approximately 1995, 20 years ago, while the patient was being treated for diverticulitis in a hospital, she received a dose of PNEUMOVAX 23 (reported as (unspecified) "pneumonia shot"), (lot number, expiry date, route, dose were not reported). Subsequently, the patient experienced a "severe allergic reaction". She stated the event as "I thought my arm was going to come off. My arm swelled to three times its size, and they had to call the doctor in the middle of the night". The patient also reported the bone in her arm hurt very badly. There were no lab diagnostics studies performed. The patient stayed in the hospital for one or two days because she "got so sick from the pneumonia shot". The events lasted a couple of days, and then recovered. Additional information has been requested.
Patient presented to ED on 4/21/21 for weakness that started one week ago.  He also complains of decreased appetite and nausea.  Patient denies shortness of breath or chest pain.  Patient was diagnosed with COVID-19 infection and UTI.  COVID was treated steroids and antibiotics,  Patient improved and was discharged to ECF for continued convalescence.
Pruritis at injection site followed by 4 cm significant erythema with large vesicles over much of the surface.
Redness swelling at injection site, size of plum on 3rd day after injection, then over next 3 days the redness and swelling spread to cover most of upper arm. Diagnosed with allergic cellulitis by doctor on 6/27. Time course until healed 2 weeks.  Treatment was benadryl and ice.
RASH ON LEG THAT IS SPREADING; This spontaneous report received from a health care professional concerned a 7 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-AUG-2021, the patient experienced rash on leg that is spreading. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on leg that is spreading. This report was non-serious.
on unspecified dates, four unspecified patients were administered an improperly stored dose of VARIVAX; No adverse effects reported; This spontaneous report was received from a vaccine coordinator referring to four unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On unspecified dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005084  and expiration date: 19-FEB-2019 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The administered doses of the vaccines were stored at the following  temperatures: from -14 degrees Celsius to -10 degrees Celsius (mainly at -13.6 degrees Celsius) for 5 hours and from -14 degrees Celsius to -10 degrees Celsius (mainly at -14.2 degrees Celsius) for 6 hours. The vaccines were reconstituted with Merck's sterile diluent lot # S014277 and expiration date: 31-JAN-2022, which was properly stored. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Volunteer developed headache, fatigue, myalgias, redness at vaccine site macular/vesicular rash on trunk, sweats/feverish sensation starting 22 Jul 10. Labs WNL, EKG nml. No cardiac symptoms, no meningoencephalitis. Motrin Rx given. Improved symptoms 28 Jul 10. Missed work days x 2.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 17-MAY-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ, orally, lot # K010224, expiration date: 13-MAY-2016, (exact dose was not provided). There were no concomitant medications reported. No adverse effects were reported. Additional information has been requested.
PO Rotavirus vaccination on 9/20/07 in doctor's office. Admitted to hospital 10/8/07 with diagnosis of intussusception. 10/25/07-records received DOS 10/8/07-DX: Intussusception. 12 days prior to admission developed low grade fever and 3 episodes of vomiting. Treated with Pedialyte and no emesis for 1 week. Last week had dark brown stools, has not had a bowel movement since 4 days prior to admission. 3 days prior to admission cranky, more fussy, intermittently crying, drawing legs up or became rigid. Vomiting began day prior to admission.
Moderate edema left arm, erythema, warmth & pain post PNEUMOVAX injection at (L) deltoid. Streaking noted (L) anterior axillary region. Moderate edema starts at clavicle ends just above elbow. Referral to PCP ASAP.
Saturday night 11FEB2023 I had a really bad headache and sore throat, the next morning I still had a bad headache and developed a fever, I tested positive it I was feverish only on Sunday afternoon as well also I just had headaches and sore throat which continued for three days on 13FEB2023 my doctor prescribed PAXLOVID which I took by Wednesday or Thursday I was feeling pretty a good and the next week back at work.
Varivax vaccine given on 12/12/02, mom came to clinic today with child starting with rash on 12/030/02; Approx 57 active chicken pox lesions on body.
The first few days, patient had exhaustion and arm pain, which was expected...it seemed to be subsiding a bit, but then Thursday morning he was hit with a wave of fatigue again. He then had severe nausea, was freezing cold, and vertigo. I took his temperature and it was 95.5 degrees. He stayed in bed most of Thursday. By about 4:00 I took his temp again and it was up to 97.1. The low body temp and vertigo was particularly concerning, so I called his Dr and was advised to make this report. He is still extremely fatigued. At this time he has not experienced vertigo or low body temp since Thursday's episode.
Pt received Pifzer COVID-19 vaccination. During her 15 minute observation period, she complained of being warm and had a hive at the injection site. Vitals were taken and were stable. She was given 15mg PO Benadryl. Patient was observed for one hour.
PAIN, REDNESS, WARMTH AND TENDERNESS AT THE INJECTION SITE.  REDNESS APPROX 3-4 INCHES IN DIAMETER.
Acute pulmonary emboli involving the distal right main pulmonary artery extending into the lobar and segmental branches of the right upper, middle, and lower lobes complicated by acute cor pulmonale
pt recv vax 31OCT95 & exp fever of 101 & tx w/APAP;9NOV95 devel a rash on chest & back & a croupy cough;rash devel by 13NOV95 & recovered from fever & cough
pt. is alert but complain of light headache and flush.  VS BP 151/106, HR 97.  symptoms was resolved and patient went home.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      On an unknown date, patient had fever of 101.8 F after 2nd dose of Moderna as reported.   Concomitant product use was not provided by the reporter. No treatment information was provided.; 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.
Previous frozen vaccine was inadvertently administered to the patient on 10/9/2022. Error was found on 10/10/2022  No reaction has been reported.
pt recv vax 8COT96 & 10OCT96 pt exp explosive diarrhea, which persisted for 4 days;it was followed by 3 days of vomiting ( 2 to 3 times per day);pt was very tired & had no appetite;
Arm very sore and tender; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication. The patient had very sore and tender arm and stated that at least he/she won't get shingles. For tolerance of 2nd dose refer case US2021AMR104396.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104396:Same patient, 2nd dose
Case number PHEH2014US019192 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 30 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
Rash on neck, under arms, upper chest, and navel every time. The most recent vaccination I also now have an itchy red rash at injection site. All symptoms begin on 2nd day after vaccines. I also developed this type of rash after my 2nd Shingrix vaccine on 9/27/19.
Patient stated day of vaccine arm very sore when still complaining the next day.  Mother noticed red, swollen arm, temperature increase 100.6. Site worse over next 2 days. (ProQuad vaccine). 5 days later red decrease, still very sore, decrease temperature.
3X3 INCH AREA OF REDNESS, SWELLING, ITCHING, NAUSEATED AND WARM TO THE TOUCH.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUN-2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, 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.
On 8/28 patient experienced muscle aches/pains which he associated as a potential side effect from the vaccination.  On 8/29 patient began developing a rash consisting of large whelps all over his entire body.  These itched and caused discomfort which he managed with OTC Benadryl.  After approximately 6 doses he was able to gain some relief.  On 8/30 the rash still persists and he has taken OTC Zyrtec as well to manage the rash.