chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lyophilized portion of Menveo reconstituted with the wrong diluent; lyophilized portion of Menveo reconstituted with the wrong diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that the patient was administered with lyophilized portion of Menveo that had been reconstituted with a diluent other than the liquid conjugate portion of vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Health care professional did not have any other details at time of call than gender and age of patient. The reporter consented to follow up. This case is linked with case US2021025190 and US2020177025, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025190:Same reporter US-GLAXOSMITHKLINE-US2020177025:Same reporter
Patient received 1 dose of adult Pfizer vaccine (lot EW0217) on 08/01/2021 at Pharmacy after lying about his age.  Patient showed up to clinic on 11/13/2021 to receive 1 dose of Pedi Pfizer vaccine (lot FK5618) and was vaccinated.  After vaccinated, patient then notified health professional that patient had previously received adult Pfizer vaccine.  Patient did not mention any symptoms after getting the adult Pfizer vaccine.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 years old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degrees Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
low grade fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MYALGIA (muscle aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (low grade fever) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Mar-2021, PYREXIA (low grade fever) and MYALGIA (muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Pyrexia: (Low) 99-100.         Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.
Patient came back at the Pharmacy 11/1/19 & showed us her left arm w/rash, swollen & itching at the route the vaccine was administered live told the patient to take Benadryl. She did take 2 doses of Benadryl. The rash stayed for 3 days while the itchiness lasted until 11/9/19
4/6/21 Received Johnson & Johnson vaccine  4/7/21 - Developed Bell's Palsy to right side   Pt has had J&J vaccine on 4/6/21 then on 4/7/21 she developed right side facial weakness and right side arm and leg weakness. She went to Facility and she was diagnosed with facial palsy and discharged on medrol dose pack and acyclovir. (note: she has right forehead area also affected consistant with LMN facial palsy). LMN does not affect right arm and right leg, so strongly suspect sinus thrombosis in the brain.  Spoke with Doctor (Specialist) regarding the Pt's symptoms and pt is being sent to ER (as Pt wishes) for admission and do MRI, MRA and PF 4 ELISA Test and neurologist consult and treat. It will be reported if evidence were found. Pt agree to go to ER, since she is getting worse over the past 1 week.
Patient received the second dose of Moderna and started feeling bad later that evening. She said she felt like a truck hit her. She fainted on the way to the bathroom at home and hit her face on the floor. She said her neck was sore, she jammed her middle finger on her right hand, and she had a sore tooth. She fainted a second time, but her husband was able to catch her. She reported feeling a little better the next day and is still recovering.
*Saturday afternoon, 3 p.m.: Shortness of breath, chest tightness, drowsiness  *Sunday (05/16): Nothing  *Monday (05/17): Nothing  *Tuesday (05/18), 1 a.m.: Tense back, chest tightness -same Tuesday, 05:30 p.m. approx.: Quick and sharp head pain from within expanding outward, followed by vertigo that lasted until Wednesday (05/19)  *Thursday (05/19): -4 p.m.: Sharp pain running from front left to back left side of head -approx. 9 p.m.: Swollen lump at clavicle that can be felt when rubbing said area  *Thursday and Friday (05/19 - 05/20): Lingering chest tightness that causes slight coughs, dizziness when in a vehicle
Patient stated her arm was very red after she received her Shingrix vaccine on 6/6/19. She then noticed a painless rash on her arm on 6/9/19 in the evening. She has had shingles several times in the past and noted this case was mild compared to the others. She was seen by a healthcare provider on 6/10/19 and they diagnosed her with shingles and prescribed an anti-viral for her. She reports not having any shingles symptoms before she received her vaccine.
According to pt mom 24MAY had sl fever & red specks on chest; 25MAY evening fever shot up, APAP given; Suddenly went limp, t104.5 given resuscitation; ambulance called; Admitted to Hosp; Given ATB;
One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Action taken was updated from previous source document.
First, dizziness and diarrhea.  Later, chills, rapid heart beat, fever, aches and pains. On the 6th, diarrhea, head ache.  On 7th diarrhea feeling better.
Covid breakthrough case. Patient presented to Hospital ER on 5/31/22. C/o fever, chills, shortness of breath, fatigue, cough, congestion x 2 days. Prescribed Paxlovid. Discharged home.
37 yo woman with a history of epilepsy and medical noncompliance found dead in her bed less than two days after receiving 2nd COVID vaccine (believed to be Pfizer). Reportedly experienced a seizure following the 1st dose approximately 3 weeks prior.
6mo old patient received Pfizer COVID vaccine that was reconstituted with 1.3 mL NS instead of 2.2mL. Thus, patient receive larger dose that recommended. Patient/parent advised to watch for increased side effects due to higher dose.
I submitted the initial adverse events through the app but I could not submit anything after the first 7 days. Woke up on the 11th and both of my palms were itching severely, red with a splotchy rash extending to the wrists. Never had this happen before with anything. Still have the rash and itches off and on. Cannot wash hands with warm/hot water because it burns, Part of my hand felt slightly swollen yesterday and skin is sensitive, feels chapped.
Started with tightness / left shoulder discomfort started about 15 minutes after vaccination.   About 40 minutes  after vaccination developed itching on ears and face around the lips.   Face and chest developed bright red blotches.  Increased heart rate .  Took Benedryl 25 mg  about 1 hour after vaccination.   Redness diminished about 45 minutes later.   Mild itching  on the face continued with intermittent episodes of increased heart rate  throughout the night and the next day.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Patient  reports getting short of air, weak, having a fever, and vomiting within 2 days of getting vaccine.
Headache and mild foot pain started 19 hours after vaccine given.  Patient went on a run about 72 hours after vaccine given and developed facial swelling, wheezing and severe bilateral foot pain and swelling.
1/30/21 Day after first shot, redness, heat and swelling at injection site. Weakness, fatigue and sever muscle aches lasted about 24 hours.   Today, 02/01/21, redness, heat and swelling still at injection site, some nausea and pain under armpit
10-27-15 Two weeks after getting varicella vaccine broke out with rash (small, raised bug bite-like) on hands, arms, feet and knees. Less than 50 spots. Itched. No fever or breathing problems.
Information regarding PREVNAR was received from a Pediatrician regarding a female patient who received 7 doses of PREVNAR. The reporter noted the patient "possibly has immune response issues and had constant sinus problems. The patient received the seventh dose on an unspecified date. Child has no history of meningitis or bacteremia. Concomitant vaccine included Pneumococcal Polysaccharide Vaccine. On unspecified dates, the patient received 7 doses of PREVNAR. The reporter indicated the patient also received approximately 3 doses of a "pneumococcal polysaccharide vaccine". Additionally, the reporter noted the patient "possibly had immune response issues and had constant sinus problems (dates unspecified). As of 03-May-2007, the patient's outcome was unknown. No additional information was available at the time of this report.
Shot was done near tattoo. Skin has sense been itchy with bumps under the ink.
Case number PHEH2011US01015 is a combined initial and follow-up spontaneous report received from a consumer and quality assurance department on 05 Aug 2011 and 10 Aug 2011 respectively: This report refers to a 96 years old female patient. Her medical history included infusion with RECLAST for the indication of osteoporosis at a dose of 5 mg per 100 ml two years ago in Dec 2009 (PHEH2011US00884). Her concomitant medications included SYNTHROID, Amlodipine, GLYBURIDE, LIPITOR and CITRICAL with vitamin D. She was vaccinated with a seasonal influenza vaccine (batch number: unknown) on an undetermined date and ended up getting flu which took her a while to get over. She forgot a lot of things because of her age and was not well. Couple of months ago she got nerve tests done at the recommendation of her doctor and she had a reaction to that too. She got a pinched nerve in her back around April or May (year unspecified) and had it for a month and a half. Also, she has muscle spasms on the inside of her thighs every once in awhile, and also had such pain down her lower back to her left legs and toes. She felt like she was climbing up a wall. It was too much pain and she couldn't eat, walk, or sleep. She had enough pain from osteoporosis. She got colds quite often, and she had a cold with coughing at the time of this report. Her colds did not go away fast, and she had to clear her throat all the time. Outcome of the events was not reported.
This spontaneous report was received from a medical assistant and refers to 8 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates in 2017 (reported as beginning sometime in May 2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M037770, expiration date: 01-JUN-2019 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 31 degrees Fahrenheit or colder for 1027 hours and 32-35 degrees Fahrenheit for 587 hours. There were no symptoms reported in any of the patients. Data logger was not involved in recording the excursion details. Previous temperature excursion was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006071: US-009507513-1709USA009874: US-009507513-1709USA009815: US-009507513-1709USA009893.
Off label use; Booster; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; CLARITINE; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number Fm0698, Other vaccine same date dose number 4, Other vaccine same date vaccine location: Left upper arm), for COVID-19 Immunization, reaction(s): "rash"; Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number Fc3183, Other vaccine same date dose number 3, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "rash"; Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number El183, Other vaccine same date dose number 2, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "rash"; Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number Ek5730, Other vaccine same date dose number 1, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "rash". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 10Sep2022 at 06:30, latency 13 hrs after the suspect product(s) administration, outcome "recovering" and all described as "Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine"; OFF LABEL USE (non-serious), outcome "unknown"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of vaccination site rash, vaccination site pain, vaccination site pruritus.  Additional information: Facility of vaccine was pharmacy or drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient developed left arm pruritic rash with pain 4x6 cm. Reported as this was only rash after 4 previous vaccines, and this was the bivalent vaccine. Patient treated with tylenol and steroid ointment.
Patient came to hospital for removal of pleural cath because it showed swelling and redness. During hospital course patient also found positive for COVID-19 infection. Patient without oxygen requirement. No indications for COVID-19 specific therapy. Patient discharged home once stable.
Pt's family called on 6/2/09 to let us know that his mother has been recently diagnosed with A.D.E.M at Hospital, possibly related to exposure to child with recent MMR vaccine.
"It started 5 hours after the vaccine with my eyes, it felt like I had something in them, thinking it was makeup I flushed them with saline which made no improvement then my throat became scrtachy, followed by SEVERE headache, nausea, achiness in my legs, uncontrollable shaking, and finally vomiting. This lasted 5-6 hours and then tapered to just the headache for the next 24 hours. I was wiped out for the next day and then by the second day I felt fine.'
blood clot in the left leg; severe left leg pain; mild swelling of left leg; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clot in the left leg) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEEP VEIN THROMBOSIS (blood clot in the left leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (severe left leg pain) and PERIPHERAL SWELLING (mild swelling of left leg). The patient was treated with MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Leg pain, at an unspecified dose and frequency and APIXABAN (ELIQUIS) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (blood clot in the left leg), PAIN IN EXTREMITY (severe left leg pain) and PERIPHERAL SWELLING (mild swelling of left leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Ultrasound Doppler: clot in leg (abnormal) clot in leg.         Patient confirmed taking regular prescribed medications but refused to give information about their names. The patient was prescribed to take a blood thinner medication and that she will be taking it for a long time.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-280246 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Two weeks to the day after my first booster I started to break out in hives over most of my body. I had not used or tired anything new in my diet, hygiene, clothing, laundry soap, etc. The hives would move from section to section and would be relieved with 50mg of Benadryl every 4-6 hours. I had two visits to the ER where they also prescribed Prednisone, Pepcid and an Epi-Pen. I had no other issues with the hives...no fever, no congestion, no nausea, no dizziness. I am currently still on Prednisone and Pepcid and am to use the Benadryl as needed. The hives would also appear symmetrically most times. When one foot started, so did the other. This also happened with my hands, knees, forearms, elbows, thighs, etc. Cont.
March 25, 2021, which is the day after receiving my 2nd dose of the Moderna vaccine, I experienced a loss of taste for approximately 48 hours. No metallic taste, but a total loss of taste. My sense of smell was still present.
pt recv vax;swelling of side & face & neck;rash on abd 10 days p/ MMR;parotitis;
4"x4 1/2" Child has red, swollen right anterior thigh, no fever, is playful and happy; since 10:00 this morning, no shortness of breath.
Dizziness, Awaiting her husband to join her.146/102, Retake 140/90, BS 108, HR 86, 97% 1:25pm Husband on scene to transport home.  Stated she feels "somewhat better".  No distress noted.
ADULT OBSTRUCTIVE SLEEP APNEA, MILD 12/23/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
The patient reported that he developed a fever in the evening (approximately 8 hours after receiving vaccine) and also had chills.  His arm was red and swollen in a very large area (up and down his arm).  He reported a sensation that his arm felt like "I got stung by 10 bees".  He felt that this limited his mobility.  He did not seek treatment with his physician nor call the pharmacy till a few days later.  He only self-treating with ibuprofen (Advil).  At the fifth day, he reported that the reaction had pretty much completely cleared.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-JUL-2016, the patient was inadvertently administered with VARIVAX, at an unspecified dose subcutaneously (lot information were unspecified) that was improperly stored. No adverse effect reported. The outcome of the event was unknown. This is one the several reports from the same reporter. Additional information has been requested.