chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back. Red bumps leaks out clear yellow liquid; Extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back. Red bumps leaks out clear yellow liquid; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0151) via an intramuscular route of administration in Arm Left on 03May2021 11:20 (age at vaccination 54years old) as single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8736) via an intramuscular route of administration in Arm Left on 05Apr2021 11:00 (age at vaccination 54years old) as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. The patient did not have known allergies. Prior to vaccination, the patient was diagnosed with COVID-19 reported as unknown. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back red bumps leaks out clear yellow liquid on 15Apr2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back. red bumps leak out clear yellow liquid.  No follow-up attempts are needed. No further information is expected.
Initial and follow-up information has been received from a registered nurse who while working part time at a high school heard from an acquaintance at the school that an 11 or 12 year old female patient was vaccinated on an unknown date with a second dose of VARIVAX. "Yesterday" the patient developed a breakthrough of chicken pox that started on injection site and went all the way down her arm. At the time reporting the patient had not recovered. The patient sought unspecified medical attention. The reporter confirmed the event but could not provide any further information. She did not get the name of patient's physician. She stated that she was only mentioning that this had happened and that the report should be coming through. No further information is available.
After receiving the 2nd booster on April 27, 1922.2 weeks later I started feeling fatique. It continued until my energy level went from 100% down to 5%.   My husband had a lung transplant in 11/2021.  I thought I was just fighting depression and energy from being at the hospital for 3 months. But during a scheduled visit again to HospitalI relaized how difficult it was to push the wheelchair and a general heavy fatique.  It became worse, with excessive thirst, dry mouth, until finally( 6/21/22) when I went to Doctor my blood sugars was over 500.  I was sent to hospital where I was diagnosed with DKA (Diaabetic Ketoacidosis) on 6/22.22, and TYPE 1 DIABETES.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 04-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
(add any additional information) Pt received a Rotarix vaccine today which was not ordered by provider. MA states "she thought the rota was a three dose series and not a two dose series. (Here at this office we use a two dose series) - but also received a Flu shot as well --  -- We wanted to report due to lack of knowledge for what a  Flu and Rotorix vaccine may cause.  There are currently no issues with the patient and Provider/parents have discussed
This spontaneous report as received from a registered nurse refers to an 11-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 14-NOV-2016, approximately days before the first birthday, the patient was vaccinated with M-M-R II (lot # reported as M022407 with expiry date on 02-MAY-2018; dose and route of administration were not reported) and with VARIVAX (lot # M030138 with expiry date on 15-JUN-2018; dose and route of administration were not reported). On 19-DEC-2016, the patient came into the office due to a fever. The outcome of fever was unknown. The relatedness between the event of fever and the M-M-R II and VARIVAX was not reported. Additional information has been requested.
Started having loss of hearing in my L ear, made appt with ENT doctor who gave me a steroid injection in ear as well as prescribing steroids to take by mouth. After 2 weeks my hearing is much worse and ENT doctor is certain this is due to Covid #2 shot.
I received  the vaccine on Friday 2-5-2021 and today is 2-9-2021 and currently still have a swollen lump in my under pit in the arm where I received the shot. I would say its a Swollen Lymph node.
There was no adverse event. I am reporting this because I give patient a Varicella vaccine, a MMRV instead of MMRII
Patient brought to ED with hallucinations and aggression.  Patient admitted to the hospital with Covid pneumonia and metabolic encephalopathy secondary to Covid pneumonia.
Approximately 6-7 hours following vaccine administration, patient had fever up to 103 and 3-4 episodes of vomiting. He was pale during the vomiting episodes. Mother offered Pedialyte. He slept well that night and seemed normal the next day.  He had no further fever or vomiting.
She got swelling in her hands and forearms; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (She got swelling in her hands and forearms) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CABERGOLINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (She got swelling in her hands and forearms). At the time of the report, PERIPHERAL SWELLING (She got swelling in her hands and forearms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (vaccination adverse reaction) in a male patient of an unknown age 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 IMMUNISATION REACTION (vaccination adverse reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (vaccination adverse reaction) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.
Itchy TIngling skin approximately 1 week after vaccine, using Cortisone 10
Spiked a fever over 100.4 degrees at work on 04/09/21. I also felt nauseous on 04/09/21. Experienced unilateral lymphadenopathy on my right arm and under my chin on 04/11/21.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on an unknown date, the patients were vaccinated with improperly stored of VAQTA (product lot#, expiry date not reported). No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
4 Year immunizations administered on 08/29/2005. Patient returned on 08/31/2005 stating left arm red and warm at the injection site.
R arm achy, traveling up arm to shoulder, neck and L arm. Prickly dots at injection site, swollen. Later developed chills, fever, congestion-all lasting x 1 week.
pain; swelling; redness; Weldts below the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and injection site wheal. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site wheal were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced pain, swelling, redness and welts below the injection site. The reporter consented for follow up.
Was good for first 18 days. Then big bruise on my arm. Doctors confirmed not a blood clot and said I was good. Keep having lots of pain in the arm at the injection site 4-5 months later
I was feeling bad after the vaccine. Weak and no energy after the 2nd vaccine. My blood pressure was dropping. I was hospitalized at a medical center for acute renal failure and hyponatremia (low sodium). Was hospitalized for overnight the Last week of March. Still have a little hard spot on the location of the vaccine that had started. On June13, dizziness, nausea, double vision symptoms. Double vision didn't last long, just a few minutes, and dizziness came and went through the day. I didn't feel good all day. I felt wiped out the next day. I called the doctor on Monday because I was to start cardiac rehab. My regular doctor called me the next day. I take Meclizine. I have been taking that for a few years but I have not taken it the last day or so but I may have taken it the day I was experiencing dizziness.
Joint ache; Muscle ache; Sneezing; Runny nose; Woke up twice very sweat; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold), HYPERHIDROSIS (Woke up twice very sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and ARTHRALGIA (Joint ache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib. Concomitant products included VITAMIN D3 and FISH OIL for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FEELING COLD (Felt cold). On 29-Mar-2021, the patient experienced HYPERHIDROSIS (Woke up twice very sweat). On 30-Mar-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). On 31-Mar-2021, the patient experienced ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (Felt cold), HYPERHIDROSIS (Woke up twice very sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and ARTHRALGIA (Joint ache) outcome was unknown and MYALGIA (Muscle ache) was resolving. Not Provided          The patient reported that she has A fib, she cannot take Ibuprofen. Concomitant products includes blood thinner medication, blood pressure medication two every morning, pill for bones and stool softener.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Reporter declined further follow-up with the Treating doctor
Extreme pain, redness, swelling up to 7" away from injection sites. Increasing pain and redness over next 4 days. Joint pain, body aches, inc. over next 3 days.  Headache, exhaustion. 102.3 temp day 4 in evening.
12/22/22 presents to ED for "fever, sob, chest pain". PMHx of "CHF, COPD (on home O2), severe AS s/p AVR on Warfarin, HTN, T2DM, CVA, Anemia, recent GI bleed (Dec 2022 requiring 1U PRBC), Asthma, Tobacco Dependence, Neuropathy, Anxiety, and Depression"
Expired MMR - expired 8/3/14 - given 8/6/14.
report an interval of greater than 6 months since 1st dose of Shingrix / Second dose of Shingrix not yet administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th July 2019, batch number-P2275, expiry date- 25th September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant called to report an interval of greater than 6 months since 1st dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter consented to follow up.
Extreme hair loss, fatigue, auto-immune problems, joint swelling and pain. 10/1/08 Reviewed vaccination & medical records.   6/26/07-C/O lower abdominal pain on right side. Vaccine records indicate different dates than originally reported: HPV #1 given 8/30/07, #2 9/20/07 & #3 12/13/07.
Bells palsey type symptoms. Left eye watery, fatigue   Going to doctor 3/9/2021, treatment on going
Acute extreme dizziness came on 33 hours after the 1st shot. lasted 3 hours; preceded a headache; Injection site hurt for two days; First night my chest felt hot; Neck & back (33 hours) felt hot after my dizzyspel- similar to the shingle burning sensation; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 26Feb2021 15:30 as dose 1, single for COVID-19 immunization. Medical history included herpes zoster, had the Shingles Virus 12 years ago and no known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks or other mediation in two weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced acute extreme dizziness came on 33 hours after the 1st shot lasted 3 hours, preceded a headache, injection site hurt for two days, first night her chest felt hot, neck & back (33 hours) felt hot after her dizzyspel- similar to the shingle burning sensation on 28Feb2021 10:30. AE resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive treatment for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hot arm; discomfort; swollen arm; could not run; right leg felt like small stings; arm felt uncomfortable.; pain in her arm; normal pain of vaccination during the day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt uncomfortable.), GAIT DISTURBANCE (could not run), PAIN (right leg felt like small stings), FEELING HOT (hot arm) and DISCOMFORT (discomfort) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003BB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Apr-2021, the patient experienced LIMB DISCOMFORT (arm felt uncomfortable.), PAIN (right leg felt like small stings), PAIN IN EXTREMITY (pain in her arm) and VACCINATION SITE PAIN (normal pain of vaccination during the day). On 23-Apr-2021, the patient experienced GAIT DISTURBANCE (could not run), FEELING HOT (hot arm), DISCOMFORT (discomfort) and PERIPHERAL SWELLING (swollen arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form and EPHEDRINE at a dose of UNK dosage form. On 22-Apr-2021, PAIN (right leg felt like small stings) and VACCINATION SITE PAIN (normal pain of vaccination during the day) had resolved. At the time of the report, LIMB DISCOMFORT (arm felt uncomfortable.), GAIT DISTURBANCE (could not run), FEELING HOT (hot arm), DISCOMFORT (discomfort), PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown.
Patient's mother called the day after child received vaccines. She states that when child returned to school following vaccination appointment, he became lightheaded, had a headache, stomachache and his nose began to bleed. She further states he had a sore throat, however she believes this is due to throat irritation related to coughing/gagging due to blood draining down throat during nose bleed. The child did not feel ill enough to leave school and finished the school day. Mother states patient was feeling somewhat better the following day, having c/o mild headache and stomacheache. Mother was instructed to discuss with PCP course of action related to finishing the HPV9 and/or Men B series. Patient's mother was agreeable.
I am three times vaccinated; have COVID right now; I am three times vaccinated/I tested positive; have COVID right now; I am three times vaccinated/I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "I am three times vaccinated"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID right now; I am three times vaccinated/I tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient tested on homecare and had tested positive. The patient has symptoms. He/she went to hospital to where he/she have been tested and it was negative (further not clarified). So, they said the patient probably have it but still have symptoms so, he/she will be isolating and taking all the precautions but have confusing data on his/her lab. The patient was not sure what that means for Xeljanz. The rheumatologist doesn't reach to the patient's calls whether the patient should continue taking it while sick. But truthfully, he/she just feel like he/she has very bad cold and the patient was three times vaccinated (further not clarified hence, suspect captured as unspecified vaccine). The patient was not feeling great.   The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Headache started 4 days after last covid 19 vaccine documented in our office on 3/4/21
no adverse event. error in administration time. The patient had stated he was 60 years old. His form had an entry that looked like 1963,  He rounded up his age to 60. He is 59 years and 3 month.  The vaccine was administered 9 month earlier than it should have. The patient has not had any adverse events