chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine shot out of the vial near the neck a close to the rubber stopper and shot out onto the physician's gloved hands and blouse with no reported adverse event; Initial information received on 23-Dec-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age female reporter who accidentally received  vaccine shot out of the vial near the neck a close to the rubber stopper and shot out onto the physician's gloved hands and blouse with no reported adverse event involving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  On an unknown date, the reporter accidentally received  Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t)( Suspension for injection)(strength, dose, frequency : not reported) via unknown route in unknown administration site for ( Product and Diluent Lot numbers, Lot number on carton-U7331AA EXP Sep 16, 2023/UJ753AB EXP Sep 16, 2023) for Immunization regarding non-serious event vaccine shot out of the vial near the neck a close to the rubber stopper and shot out onto the physician's gloved hands and blouse with no reported adverse event (accidental exposure to product) (Latency- same day )   It was reported Physician is calling to report that she was preparing a PENTACEL vaccine and after she placed the DTAP-IPV into the ACT-HIB vial the vaccine shot out of the vial near the neck a close to the rubber stopper and shot out onto the physician's gloved hands and blouse. The MD did not use the vaccine and noticed a slight crack in the vial. When a product complaint is received for Pasteur product(s), please collect the following information in addition to the questions on the Transfer screen:  Description of complaint (as much information as possible) sprayed out of the top part crack in the neck. Number of units affected-1 VIAL, Is dose not used or not available NOT USED Were there any signs of damage to any other vial in the carton- ON THE NECK OF THE VIAL  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
01/17/22 presents to ED for "elevated blood sugars and altered mental status". PMHx of "positive for COVID-19 on 1/6/2022 " "type 2 diabetes with peripheral neuropathy, left BKA,  A. fib on Xarelto, hypertension"
fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection; fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection; This is a literature report for the following literature source(s): DOI:10.21203/rs.3.rs-1662783/v1.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: "VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "fully vaccinated and boosted with the BNT162b2mRNA vaccine but one had been infected with and recovered from a SARS-CoV-2infection". The patient underwent the following laboratory tests and procedures: Antibody test: unknown results; Gene sequencing: unknown results; Phenotypic analysis: unknown results; Nasopharyngeal swab: unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Authors next evaluated the susceptibility of the viral panel to the neutralizing antibody response in the plasma from the patient and two controls. Both controls were fully vaccinated and boosted with the BNT162b2mRNA vaccine (Pfizer-BioNTech), but one had been infected with and recovered from a SARS-CoV-2infection with symptom onset 3 days prior to the individual who experienced NM/r recrudescence. The average half maximal authentic virus neutralizing antibody concentrations (NT50) against BA.2 PRSD01, BA.1, and parental were, 1668, 1170 and 5239 respectively in the NM/r treated patient. These levels were 8.9, 7.1 and 2.1 times higher than the boosted control but 2.0, 1.7 and 2.6 times lower than the boosted and infected control. This study found that neither development of NM resistance or absence of neutralizing antibody were likely causes of the recrudescence. Although authors were unable to measure T cell responses or drug levels, authors feel the most likely possibility for the observed recrudescence is insufficient drug exposure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 vaccine in this patient cannot be completely excluded.
RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned an elderly female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose and start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: RINVOQ (upadacitinib) (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, after receiving vaccine the patient experienced rheumatoid arthritis flare up. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The outcome of rheumatoid arthritis flare up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211135061-COVID-19 VACCINE AD26.COV2.S-Rheumatoid arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
This spontaneous case, initially received from other non-health professional on 23-Oct-2018, concerns a 66-year-old, elderly female patient. The patient's current condition included low thyroid levels. The concomitant medication included SYNTHROID for an unknown indication. On 03-Oct-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250979 and expiry date: 31-May-2019). On the same day, after vaccination, the patient experienced soreness in her arms for more than 24 hours. The patient could not lift her arm to shoulder height. It was reported that 3 weeks after vaccination, the arm was still sore. It was not excruciating but was uncomfortable to sleep and difficult to get the right position to sleep. The patient used hot packing at night and TYLENOL and ibuprofen alternated as a treatment which helped her a little but didn't resolve completely (recovering). The reporter assessed the case as non-serious.
Had an instanteous redness develop about the size of a "flat tennis ball" with a hard area appearing 7 hrs after the shot since the hardness came have a pulsation feeling in left arm, still! Took two Ibuprofen Sat evening and two on Sunday evening.
As a result of the influenza vaccine, I developed Guillain-Barre Syndrome. I experienced chronic fatigue, double vision, breathing issues, and minor paralysis. I had plasmapheresis and PT/OT for treatment. This was over the course of a few months.
hives, erupted less than week after administration of second Pfizer vaccine dose, no other potential triggers identified
Wheezing, shortness of breath, and cough. Patient does not want to be contacted. From RTIMS Study.
Noticed blotches that kept getting worse & more red; Eyes swollen-pus fr lt eye; blotches on both arms, chest, head, & legs also sneezing; Seen by MD;
Headache, fatigue, body aches and chills started roughly 6 hours after the shot. The headache continued into the following day, but was helped with Aspirin. A rash started on the underside of my upper arms bilatterally 7 days after being vaccinated. It then spread all the way down my arms and on both upper thighs and down the back side of my calves on the 8th day after being vaccinated. Hydrocortisone cream was applied on 12/30 with little to no relief. Benadryl was taken 12/31 2 times. Once the benadryl kicks in, the rash is not nearly as itchy. But without the benadryl the rash is almost unbearably itchy. I work in an ER, so I will be recieving methylprednisolone here shortly to hopefully help. There is also a golf ball sized red mark roughly 4 fingers down from my injection site that started 12/31. It started the size of a quarter and has since grown in size as the day has gone on.
nausea/vomiting for 3 days prior to 2/18/22; chest pain, sob, syncope, fatigued with body aches.
Patient's eyes began to burn and got really blood shot. Called Pharmacist and recommended Benadryl. Worse on Tuesday 11/10/2011 and got Systane Gel Drops from Eye Doctor. Better but still red and irritated.
Severe tiredness, muscle soreness, joint soreness, brain fog/trouble reading/concentrating, chills.
Tired the day following the second COVID vaccine dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Tired the day following the second COVID vaccine dose".  Additional Information: The event lasted about a day and a half.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of appetite; Sniffles; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite) and RHINORRHOEA (Sniffles) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LAMOTRIGINE (LAMICTAL), TOPIRAMATE (TOPAMAC), METOPROLOL and POTASSIUM for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and RHINORRHOEA (Sniffles). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DECREASED APPETITE (Loss of appetite) and RHINORRHOEA (Sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-037319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received and contains no new information
Information  has been received from a consumer concerning his 13 year old son with sensitivity to unspecified vaccines with a history of allergy to vaccine who in January 2009, was vaccinated with MMR. In January 2009, the patient experienced high fever, rash and generally not feeling well. Subsequently, the patient was recovered.  Additional information is not expected.
24 hours after, fever and aches. Severe chills. Disappeared after 6 hours. 48 hours after, fever and aches. 3rd day (today) woke with rash on vaccine arm, chest and neck, and rib cage.
TESTED POSITIVE FOR SALMONELLA INFECTION; This spontaneous case (PVX2019-1090) was received from a nurse on 02-May-2019. It describes a 19-year-old adult female consumer who was tested positive for salmonella infection, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all the four doses of Vivotif from 23-Apr-2019 to 29-Apr-2019. On 29-Apr-2019, she had bloody diarrhea. Later, she underwent polymerase chain reaction (PCR) test for her stool on 01-May-2019, which was positive for salmonella. The nurse said that a culture test was also performed but the results were awaited at the time of the report. The nurse believed that the patient was fine and having no diarrhea at the time of the report.  The consumer had a medical history of irritable bowel syndrome and previously had bloody diarrhea intermittently, before taking Vivotif (gap not specified).  Action taken with Vivotif was unknown.  The clinical outcome for the event salmonella infection was unknown.  Company's Comment: In this case, it was reported that the consumer was tested positive for salmonella infection within ten days of administration of oral Vivotif.  The protective action starts about ten days after taking the last vaccine dose. Also, the vaccine strain cannot be detected in the stool after the usual dose. Hence the event is a natural infection and the causality has been assessed as not related to Vivotif vaccine.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer was tested positive for salmonella infection within ten days of  administration of oral Vivotif.  The protective action starts about ten days after taking the last vaccine dose. Also, the vaccine strain cannot be detected in the stool after the usual dose. Hence the event is a natural infection and the causality has been assessed as not related to vivotif vaccine.
The morning after the shot I began to feel achy in joints, headache,  upset stomach and slight nausea, my arm hurt at the site,  Temp 98.9 temporal.  I took Ibuprofen, worked and 6 hours later felt the same so repeated Ibuprofen and then it was over with. No further untoward problems.  The injection site still hurt 2 days and  was bruised 3 days.
I started having a dry cough then a lot of post nasal drip. It went right to my lungs with congestion.  I was also super tired thursday may 26th i self tested positive with covid. the previous day it was negative I called the doctor and got paxlovid and started that night and it completely reversed the symptoms so in two days i had a lot less symptoms. I tested negative on may 30th and 31st.
She was feeling lightheaded at 6:15PM. The client ambulated and sat in the anti-gravity chair. Vitals obtained at 6:21PM were as follows: HR 55, O2 99%, and automatic BP 108/64. The client was provided water at 6:24 PM and began drinking it. The client denied any other s/s of anaphylaxis. At 6:28PM the client stated the lightheadedness was improving. Client was moved to a reclining position in the anti-gravity chair. Repeat vitals obtained at 6:31PM were as follows: HR 53, O2 99%, automatic BP 110/72. Educated the client and her family on s/s of anaphylaxis, when to seek EMS, and V-safe. Client and her family voiced understanding of this education. Client denied any current medications. No known allergies. Repeat vitals obtained at 6:41 PM were as follows: HR 58, O2 99%, and automatic BP 109/68. The client denied feeling lightheaded at the time. The client left the vaccination site at 6:44PM. The client ambulated unassisted with a steady gait.
medication was given to an infant- with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Infant with unknown age and gender patient who experienced medication was given to an infant- with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection (strength, dose, route,lot number not reported) in unknown administration site for immunization.  On an unknown date the patient reported medication was given to an infant- with no reported adverse event (off label use) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event off label use.
The evening of the vaccination, I experienced rapid heart rate but only for a minute or less.  The following day, I was fatigued and had arm pain.  A few days later, the injection site was itchy and warm to touch.  This lasted until day 8.
This spontaneous report as received from a 55 year old female consumer with allergic to sulfa drugs and no pertinent medical history refers to herself. On 20-SEP-2014 the patient was vaccinated with ZOSTAVAX (lot #, expired date and route unspecified, one dose) and influenza virus vaccine (unspecified) (lot #, expired date, dose and route unspecified) at the same time. No concomitant therapy included. On 04-NOV-2014, the patient stated that she began suffering from the shingles. The patient sought medical attention and had been prescribed ZOVIRAX. No lab diagnostics studies performed. The outcome of shingles was unknown. Additional information has been requested.
Information has been received from a medical assistant concerning 3 children who in February 1999 were vaccinated with varicella virus vaccine live. Subsequently the children developed varicella. No further information is expected.
Redness & swollen at injection site with total area  of 2 1/2" x 1 1/2". Itched the first day & sore to touch at day 4 after injection.
Headache/ headaches have been stronger; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache/ headaches have been stronger) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis and ROSUVASTATIN for an unknown indication.    The patient's past medical history included Stomach ache (abdominal pain upper) and Headache. Concurrent medical conditions included Multiple sclerosis, Alopecia (Her hair came out in chunks) since March 2021 and Hair loss (She was having hair loss since starting the medication).   On 18-Mar-2021, the patient started TERIFLUNOMIDE (AUBAGIO) (Oral) 14 milligram once a day. In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ROSUVASTATIN (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache/ headaches have been stronger). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In 2021, HEADACHE (Headache/ headaches have been stronger) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Hepatic enzyme: liver enzymes had increased and liver enzymes are good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stopped rosuvastatin two months ago because her liver enzymes had increased (Hepatic enzyme increased) (onset: unknown date in 2021, latency: unknown). She had a lab work done since then and her liver enzymes were good now.  No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Client states that a week after he received the vaccine he noticed it was swollen, red and sore. He states the site on the left deltoid has continued to be red, swollen, and tender. A reddened area approximately 15mm noted with a 4 mm scabbed area in the middle noted on left deltoid.
Pain and swelling for over two weeks now.; Pain and swelling for over two weeks now.; Difficulty using right arm; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep8731) via an unspecified route of administration in the right arm on 22Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 01Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 00:00, the patient experienced pain and swelling for over two weeks at the time of the report. The patient also experienced difficulty using right arm. The adverse 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain and swelling for over two weeks now, difficulty using right arm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sensation of skin crawling primarily in left ear and left side of face. Also have occurrences on all regions of my body. Sensations are random in occurences, but are intense in feeling when they occur. Feel like insects burrowing underneath my skin .
Patient received the above vaccines on exam table and ambulated across room to a chair. 3-5 minutes, while the patient was sitting in the chair, she was watching her brother get his vaccines and began shaking and became diaphoretic. Shaking subsided without intervention. Patient was observed in clinic. During which time she was given water to drink and ice pack. Patient was no longer shaky, ambulatory, acting appropriately, alert and oriented, without reports of vision changes prior to leaving clinic.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium
Patient was given red cap moderna at age 17 years old.  Red cap moderna is not approved for those under age 18