chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/11/2021 at approximately 1715 I RN Nurse Manager realized that additional doses of the COVID clinic would need to be mixed and drawn up for the remaining patients on the schedule. I went into the medication room to mix a vial of the COVID vaccine with normal saline as I had been taught to do earlier in the day with the Pharmacist. I opened the red bag of supplies to mix up the vaccine and only found one vial in the bag with a salmon colored top. Remembering that that the vaccine came in a vial with an orange top I believed this to be the vaccine and was looking for the diluent. Unable to locate some I called pharmacist and she informed me that I was fine to use normal saline from another source to mix the vaccine. I located another source of normal saline within the clinic and used it to mix 1.3ml of normal saline into the vial. After following the mixing instructions of inverting the initial vial 10x, added the diluent, removed 1.3ml of air, and then inverted the vial 10x to mix, I then drew up multiple syringes of 0.2ml RN adjunct professor and an MA each took two syringes to vaccinators who were waiting to administer the vaccine to patients. approximately 10-15 minutes later a colleague and I called pharmacist to ensure I knew how to properly dispose of the unused vaccine. It was during this conversation that I realized I had not used the COVID vaccine vial but had used the diluent vial and had mixed additional NACL into the diluent vial. I immediately asked who had received the last 4 doses, 3 of those patients were still in the building and 1 patient had left. I notified the parents of the 3 children who were still on the premises of the error that was made and apologized. I then asked if they would still like their child(ren) to receive the COVID vaccine tonight and the parents agreed. Those 3 children each received a dose after I went back into the med room and correctly mixed the vaccine. The children remained under observation for 15 minutes and were then discharged.
diarrhea - has been ongoing all day, from about 9:45am through at least 4:15pm.
Pt inadvertently received a Pediarix instead of DTaP. The result is that he received an extra dose of polio and a double dose of Hep B. Pt experienced no adverse reactions. Pt's mother was notified. Follow up on 01/23/04: "No adverse reaction occurred in the pt.  Date of vaccine 12/29/03.  Report is valued mistaken dosage."
Patient given high dose flu vaccine at 43 years of age, so does not meet minimum age requirement approved for this vaccine.  Vaccine was given at a drive thru  mass flu clinic by a volunteer nurse practitioner.  NP is not employed by  Health Department.
I can't give the details DUE TO COVID POLICY NO VISITORS ALLOWED AT THE TIME OF INCIDENT -   He called home - from Hospital on the morning of the 9th - upon talking with him he said I think they have pumped 200 years of medical medicine into me - yet by the evening THE HOSPITAL  called, he was on LIFE MACHINE SUPPORT -
pt states she got 101 fever, nauseated, body aches, and sore left arm after getting the covid vax.  These symptoms lasted for 48 hours.
devel swelling lt side of neck 2 days p/recvd inject; 4 days later large node lt side of neck 17JUN92 devel sore throat & seen @ clinic; 2cm tender node lat ant cervical, 1cm tender lt submandibular;
I became unable to urinate and walk. I went to the ER. They did a neuro exam and determined there was serious issues. After a MRI it was discovered that I had lesions in my spine. I was diagnosed with transverse myelitis. I spent about 2 weeks in medical center receiving IV steroids and doing physical therapy to try to regain my ability to walk. I have had many flare ups, and still use catheters to urinate. I have been hospitalized many times. I have nerve pain, memory issues, balance problems.
This case was reported by a healthcare professional and described the occurrence of raised red lump at injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included drug allergy, high blood pressure, hypothyroidism and subdural hematoma. The subject smoked 1/2 pack a day and did not drink alcohol. concurrent medications included phenytoin (Dilantin), Thyroxine sodium (Levothyroxine and Atenolo1. On 17, October 2006 at 14:30 the subject received unspecified dose of Fluarix intramuscularly in the right deltoid. A day later, on 18, October 2006, the subject developed an almond sized, red, swollen, hard, painful lump at the injection site. Then the area became blistered. The subject developed fever blisters on her nose and lips. a stuffy head and nose and had head congestion. The subject physician advised her never to get the flu vaccine again. At the time of reporting the outcome of the events was unspecified. Follow-up information was received from the healthcare provider on 03 April 2007. According to follow-up, the subject received flu vaccine (unspecified manufacturer) in past years. "Four years ago, she had soreness at injection site" at unspecified time after receiving the flu vaccine. It was also reported that the subject had soreness at injection site "previous years". The outcome of the soreness at injection site was not provided. With events that subject experienced on 18 October 2007, the healthcare profesional reported diagnosis as a vaccine reaction. The vaccine reaction and associated symptoms resolved on an unspecified date. The reporter considered it possible that the vaccine reaction was related to vaccination with FLUARIX. Treatment included unspecified antibiotics on four occasions for "respiratory and/ or sinus" since receiving vaccination with FLUARIX. The FLUARIX was not reintroduced to the subject.
Had Tdap 6/12/07. Woke up 6/19/07 am with itchy, erythema, edematous right upper arm
5 minutes after receiving the vaccine my mouth started to feel numb and tingly, then my whole face felt numb and then I felt it rush through my body.  They told me it was histamine being released in my body and that it was normal.  The kept me only for the full 15 minutes.  I had a dissolvable Zyrtec on me, so I took one 10ml.  After about 45 minutes to 1 hr my face felt normal again.  Until that time my face felt as if it was puffy and had a numb feeling.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 29Aug2021, the patient developed chronic spontaneous urticaria. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent PCR test (nasal swab) and the result was negative. No therapeutic measures were taken as a result of event. The clinical outcome of the event chronic spontaneous urticaria was not resolved at the time of this report.
Symptoms began approximately 11 hours after 2nd dose of Moderna Covid vaccine.  Fever that maxed out at 101 degrees 2-hrs later, headache, stiff & sore neck, mild shivering & chills, hand tremors, eyes hurt, stuffy sinuses, balance problems & stumbling, spacey feeling (disorientation), painful cramping in thumb & fingers of one hand (only occurred once), extremely fatigued & lethargic, no appetite.  All symptoms resolved within 16-18 hours after onset.  No treatment.  Resolved spontaneously.
Eating at local restaurant on 1/12/13; suddenly noticed development of lower lip numbness, heaviness, and lips felt droopy.  Developed intense body chills/ shivering.  Developed global body weakness; fingers turned blue. Given Clarinex at home-breathing was tightening. Taken to local ER for evaluation.  Unable to walk on own power. Follow-up appts: 1-16-2013 w/pediatrician, 1/21/13 w/neurologist.  Reported persistent symptoms of global body weakness, easy fatigability, widespread muscle achiness, intermittent speech stuttering for 1-2days. Not able to feel hands/feet at initial onset 1-12-2013. Patient states she feels her symptoms are decreasing, although she is not yet back to baseline.  Neurologist assessment: Possible patient has very mild Guillain-Barre-like syndrome post flu vaccination.
Initial report received on 03 September 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received the following 3 doses of PENTACEL vaccinations: lot C3228AA received on 08 June 2009, lot C3290AA received on 03 August 2009, and lot C3231AA received on 29 September 2009. The subject developed a cough on 05 August 2013, approximately 4 years after the last dose, and a paroxysmal cough without a whoop on 13 August 2013. The subject also developed sleep disturbance (start date not reported). No laboratory testing or chest x-rays were reported. Corrective treatments consisted of azithromycin starting on 05 August 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 19 August 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. This case was epidemiologically linked. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 211 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 03 September 2013. These 211 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
A week after vaccination, I developed itchy eyes and blurred vision, stiff neck right side, and a large itchy rash on upper left arm. Symptoms lasted 4 days then completely disappeared.
Initial misuse report received from a healthcare professional on 10 September 2013. The patient (No information was provided regarding the patient) gave twins ACTHIB, only one got a reconstituted vaccine, they do not known which one received only diluents. No adverse event was reported. List of documents held by sender: none.
Information has been received from a licensed practical nurse concerning a patient who on an undisclosed date, was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657109/0444U), and subsequently developed a non vesicular welt. This is one of several reports received from the same source. Additional information is not expected.
Breakthrough case admission after 2 vaccines  Moderna 2/20/21 lot# 023M20A;  Moderna 3/20/21 Lot#  007B21A
I am writing you this letter, as far as name of drug used will have to be checked out by the department. I could not get info from pharmacy of the drug used in flu shot received on 11/4/2013. I do not know if proper care was done to insure safety of drug, that is why inspector will have to check this out. I still can not believe this drug used for the flu has contains weed killer in it. I read on and I found out that even the doctors do not know about this. My reaction to the flu shot was devastating. I could not talk, use my hands, legs and arms, my blood pressure was extremely high, uc care doctor would nothing for me sent me to ER where again the doctors did not know even when I felt my body come back the doctor said tell you did not have a stroke, which I have worked for Doctor and even I know that I was not a stroke. It was from the flu shot. I have used weed kill in my yard once and reading cover eyes nose mouth wear rubber gloves if you get any on bare skin wash asap with soap and water. I feel this drug should be taken off the market asap. I almost died not to mention a large Hospital bill which I feel Food and Drug should pay for knowing all along there was a DANGEROUS NEUROTOXIN IN THE FLU SHOT!!!!!! I have also found out that people have died. My question to you how many more people will go through what I did or die before Food and Drug will take this dangerous shot off the market!!!!!! I thought that food and drug was looking out for our safety in the shots or meds we are taking was safe for all ages, guess I was wrong. Oh about Hospital bill I have been told that Food and Drug does have a responsible for allowing a dangerous drug to be left on shelf or shot that have a dangerous neurotoxin in them. Response to letter requested. Please help me save any more people from going through what I did or dying!!!!!!!
Breakthrough case, confirmed by certified lab PCR (nasopharyngeal swab). No hospitalization required. Mild symptoms lasting 3 days: mild fever, diarrhea, fatigue, headache, sore throat, chest tightness.
Information has been received from a male patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). A couple of days since he got the vaccine he had a red spot the size of a silver dollar at the injection site and it itched. He mentioned he would be contacting his doctor. The action taken and the status of the patient were unknown. No further information is available.
pt recvd vax & had red welt; crying; screaming from about 1 hr after inject until about 5pm; fever 103;
Fever, body aches, severe headaches, "knot" at injection site, upper arm red from shoulder to elbow. Redness subsided 5 days after injection. Treated with ibuprofen, diphenhydramine, hydroxyzine.
mom reports arm swelling of lt arm from shoulder to wrist; no fever; also redness; 5MAY93 seen by MD given DPH & told avoid DT; 6MAY93 swelling beginning to dec, no streaking; still warm to touch;
Red inflammation around injection site. Patient does have a latex allergy, but band aid was latex free.
Pt developed intense pruritis/urticaria. Treated with Benadryl then Tagamet.
Employee stated that the morning after the vaccines she notice the area below injection site was sore with some redness. On Friday October 17th employee notified the Employee Health nurse that the area has increased redness, soreness and is warm to touch. Employee was instructed to come for further assessment. Site was assessed by Employee Health and physician. It was noted to have 10mm X 10mm of redness with 3mm X 3mm induration.
Developed a rash to axillary area of R arm where I was injected 12 days after; This is a spontaneous report from a non-contactable reporter (nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 at 10:15 (Lot number: unknown) at the age of 51 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN; "Hair loss" (unspecified if ongoing); "Thalassemia minor" (unspecified if ongoing), notes: Thallasemia minor; "Hyperlipidaemia" (unspecified if ongoing), notes: HLD; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: PCN and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication included: BENICAR.  The following information was reported: RASH (non-serious) with onset 12Dec2021, outcome "not recovered", described as "Developed a rash to axillary area of R arm where I was injected 12 days after". Therapeutic measures were not taken as a result of rash.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client reported to vaccinator RN that he experienced chest pain and SOB after his 2nd dose Moderna COVID vaccine on 04/11/2021 that resulted in hospitalization for approximately 48 hours. Client reported onset of adverse reactions was about 24 hours after receiving his 2nd dose Moderna COVID vaccine. Client reported he recieved pain medication for treatment in the hospital and was advised by PCP to proceed with receiving Moderna Booster. Lead RN  submitted a medical consult via test message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Moderna Booster. RN received approval from MD to proceed with Moderna Booster. Client received COVID vaccine Moderna Booster (lot# 066F21A) at approximately 0315 in the R deltoid and was instructed to be observed 30 minutes and f/u with PCP. No adverse reactions reported during observation. Client left vaccine site with steady and symmetrical gait.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-AUG-2015, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD, injection, lot # L019996, expiration date 02-DEC-2016, (route of administration and anatomical location were not reported). There were not concomitant medications reported and any product quality issue involved. Additional information has been requested.
There was no issue from the vaccination itself; sore arm, a bit tired and achy the next day only. I was stung multiple times by hornets yesterday, and the reaction to the stings was much more severe that what I have experienced in the past. My wife has also experienced the same thing with stings she has received since getting our second shot. basically swelling, redness in ~2" radius from the sting location, itchy as heck. Typically I would have ~0.3-0.5" redness radius. Took Benadryl (25mg) no other issues other than the reaction to this still is much worse than in the past, and i was wondering about the vaccine (pfizer) possibly influencing this and figured i'd report my experience.
Vomiting and Diarrhea for 1-2 weeks:  October 14, 2004 and February 8, 2005.  Facial paralysis and numbness on left side/prednisone and valtrex.
pt recv vax 24JUN97 between 2:20-2:30PM & 2:55 pt observed by family member to be itching lt lower back;lt arm deltoid area & lt lower back observed to have very sl, raised red area;BP 88/60, AP 92;3:45 no evidence of reddened area;
Started having angina that ended up having 3 Stents placed in my heart. Continue to have angina and taking medication for it.
This spontaneous report was received from a nurse refers to unspecified number of patient of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions was reported. On an unspecified dates, the patient were vaccinated with improperly stored doses of PNEUMOVAX 23 from lot# N001007 with expiry: 19-SEP-2018, for prophylaxis. No adverse effects reported. The vaccine was stored at a temperate of 9 degree Celsius to 25 degree Celsius for 34 minutes. The temperature excursion was detected by digital data logger. The vaccine had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007839:
Worker was given flu vaccine in the sub-q area of her right arm instead of the deltoid muscle by MA-C who was not authorized by Occupational Health to give this vaccine. Worker felt tingling in her right arm and has 3" red area at the site.
Had erythema at Td injection site LA and ulceration that began 8/31/04. 9/9 saw Dr, took antibiotic PO and used cream. Site is healing but area still not completely healed.
Injection Site Pain; Injection Site Swelling; Red circle at the injection site; Area was hot as fire; hurt muscles; flu like symptoms; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth, muscle pain, influenza-like symptoms, shivering and headache to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm in her physician's office. The patient experienced pain, swelling and a red circle at the injection site. Less than a day after receiving Shingrix, the area was hot as fire and swollen. Less than a day after receiving Shingrix, the patient experienced hurt muscles, flu like symptoms, shivering and a headache. The patient's reactions continue to be unchanged. The reporter consented to follow up. This case has been linked with US2019158372, reported by the same reporter.
L post. deltoid pain since time of injection until date of evaluation at clinic, 11/30/17.
Patient reports being at a concert on 8/28/21 and around 2000 patient had witnessed seizure-like activity including eyes rolling back in her head with bilateral arm stiffening and shaking. Episode lasted for approximately 1 minute with unresponsiveness lasting for approximately 1 minute after episode, and confusion for several minutes after regaining responsiveness. Patient is unable to recall event, but husband witnessed and supplied history. Prior to the episode, there were strobing lights and patient was passively exposed to cannabis smoke. During ED visit, the patient was found to have a urinary tract infection. Patient was discharged with prescriptions for Macrobid and Keppra. The patient was instructed to follow-up with neurology.
fall, low grade temp 99.8 Narrative: 67 yo patient with lewey body dementia, with h/o of falls had 2 falls within 3 days of covid 19 vaccination on 12/22/2021, with falls on 12/23 and and 12/24. Vet with noted confusion that was noted to be exacerbated by recent vaccination. No additional notation of orthostastic Bp or other noted symptoms to confound fall besides mechanical.