chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within the first 24 hours she showed a look of serious aging, and then the following day extreme pain in the mid and left side back making it difficult to walk or move. Severe pain. The pain seem to shift around like more nerve pain showing in the muscle . Started on the left side but moved around.  This was initially helped with some strong curcummin/boswella (inflammation pain formula at our health food store) and a homeopathic remedy. But the symptoms came back and kept going . She is very active and was unable to do her regular routine. She was sleeping more and in considerable pain. After several days, we tried what another country recommends for reactions to vaccines and it seemed to help her within a very short time. There is still now residual pain but she is better.  We have GREAT concern over what a second dose could do and do not feel that with such a strong reaction the second dose safe. Also a great concern that the same amount of vaccine for a 250 pound person and a 100 pound elder. She is very tiny bones and weighs around 100 pounds are less. Very concerning as no medicine is usually the same for everyone. Also a concern of why just one month from second dose when it takes a known 6 weeks for blood to change. A high chance of severe reaction can happen with such a close proximity and a second dose. We would like to see advise of no second shot or considerable less for small people. CDC person recommended she switch vaccines?  That seems risky and there is no studies of adverse reaction to combining two different vaccines.  She would like to be comfortable moving around in public and is of great health for her age so this reaction was very concerning. If she had such a reaction on FIRST DOSE....wouldnt that be a indication that her body reacted and a second dose not necessary  advisable. Please advise. This is of great concern to all of us who love her and of great concern for the general public who may be at risk for such adverse effects. I put unknown below because she still feels some pain even though it is less.
PT CALLED AND STATED HER HAND WAS SWOLLEN AND SHE WAS FEELING SOME NUMBNESS SYPTOMS STARTED 12/23/2017 IN THE MORNING SHE STATED.
terrible headache; tired; my temp is 100.1; feel like I have bad heartburn; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th April 2020, the patient received the 2nd dose of Shingles vaccine. On 7th April 2020, 1 days after receiving Shingles vaccine, the patient experienced headache, tiredness, fever and heartburn. On an unknown date, the outcome of the headache, tiredness, fever and heartburn were not recovered/not resolved.   It was unknown if the reporter considered the headache, tiredness, fever and heartburn to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had terrible headache, was tired, their temp was 100.1 degree F, and they feel like they had bad heartburn.
Stated he "felt out of it for the day" after receiving his first dose of the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient), from a sponsored program.   A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single for covid-19 immunization. The patient medical history included ongoing diabetes. Concomitant medications were not reported. It was reported that, patient stated he felt out of it for the day after receiving his first dose of the COVID-19 Vaccine. Patient stated he has his second COVID-19 Vaccine scheduled today, 09Feb2021. He said there is a snow storm in his area, and he doesn't know if where his is scheduled to receive his second COVID-19 Vaccine will be available to administer his second COVID-19 Vaccine dose.  He said his first COVID-19 Vaccine dose was on 19Jan2021. He said he has a cardiologist and has done his treadmill stress test. He said he has no stents. No further details provided. The patient underwent lab tests and procedures which included treadmill stress test (exercise electrocardiogram): unknown results on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Initial unsolicited report received from healthcare professional on 22-May-2017. This case involves 20 years old female patient who was vaccinated with a second dose of IMOVAX (batch number: M13142M, expiry date: 19 June 2018 and route of administration was not reported) in the gluteal muscle on 18 May 2017 in morning. Patient did not have illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medication. On 18 May 2017 at night few hours following vaccination patient developed nausea, vomiting and diarrhea with low grade fever. Patient did not perform Laboratory investigation. Corrective treatment was not reported. On an unspecified date patient was recovered from events. It was reported that events lasted about a day or so and resolved. List of documents held by sender: none.
pt recv vax 25FEB98 & on 26FEB98 rash on lt side of face, front of neck, lt upper arm;advised to take to MD;blackout spells does not think had them a/getting vax;lump on groin;
2 month-old received Flulaval; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 79ED9, expiry date 30th June 2023) for prophylaxis.   On 17th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 17th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 19-Jan-2023 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient received a dose of Flulaval quadrivalent by error at inappropriate age, which led to inappropriate age at vaccine administration.
This spontaneous report as received from a nurse refers to a 6 months 19 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 06-AUG-2007, the patient received the first dose of GARDASIL (lot number, dose and route not reported). On 08-OCT-2007 the patient was vaccinated with the second dose of GARDASIL (lot number, route and dose not reported). It was reported that the patient was concerned because the she wasn't sure if she had the third dose of GARDASIL or not. No adverse effect reported. Additional information has been requested.
Tinnitus, very persistent, generally tolerable, but at times fairly loud. All times of the day.
Caller stated that she gave a patient the vaccine IM in his deltoid muscle and not in the back of his arm with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a male patient of unknown age who was administered with the YELLOW FEVER VACCINE - [YF-VAX] vaccine intramuscular in his deltoid muscle and not in the back of his arm with no reported adverse event.  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 Solution for injection of YELLOW FEVER VACCINE - US in his deltoid muscle intramuscular and not in the back of his arm  (dose, strength, expiry date, batch number was unknown) as prophylactic vaccination (incorrect route of product administration) (latency: same day).  It was reported "The pharmacist would like to know if the patient will experience more adverse events because it was administered IM and if she should call the patient. The pharmacist states that there is no literature out there on this and it can be very common mistake because 90%, if not more of the vaccines, are to be administered IM. This is all the information the pharmacist provided at the time of her call."  Action taken was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
54-year-old female presented to the emergency room on 10/26/21  at approximately 16:25  with complaint of shortness of breath/wheezing from outpatient MRI department.  Patient stated that prior to the MRI she was feeling fine and after multiple unsuccessful IV attempts the patient started to get short of breath. IV was successfully placed and MRI completed without issues aside from the fact that patient remained short of breath. Patient was short of breath prior to IV contrast administration.  She received 3 prior MRIs with IV contrast in the past without any issues or allergies.  Of note the patient did receive Covid vaccination yesterday on 10/25/21 at 11:30am and is on losartan, not on any ace-inhibitors.  Initially on exam the patient appeared to have an expiratory stridor.  Due to the stridor we did administer 2 rounds of racemic epinephrine nebulized with no improvement.  Patient then received albuterol for which she states she felt slightly better.  In the meantime the patient received IV dose of steroids.  We then underwent a CT of the neck which showed moderate laryngeal and epiglottic fold edema with the most narrowed area of the airway measuring 2.8mm in diameter.  At this time decision was made to transfer the patient to a facility that had ENT as backup in case of the need for intubation which would be considered complicated. Spoke with Dr. at Hospital.  At this time the patient had improvement of her symptoms however was still having audible expiratory stridor.
Unable to sleep; Body felt cold; Hoarseness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (Unable to sleep), FEELING COLD (Body felt cold) and DYSPHONIA (Hoarseness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Unable to sleep), FEELING COLD (Body felt cold) and DYSPHONIA (Hoarseness). The patient was treated with PARACETAMOL (TYLENOL) for Feeling cold, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Unable to sleep), FEELING COLD (Body felt cold) and DYSPHONIA (Hoarseness) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.
Initial information received from another manufacturer (inquiry number 1-182158319). The other company received the information from a consumer (the patient's parent) on 26 October 2008.A male patient received "DTP" (manufacturer unknown), lot number not reported, and experienced "brain damage" an unspecified amount of time later. Recovery status was not reported. No other information was provided. Additional information is not expected. List of documents held by sender: none.
Jansson (J&J) 1805029 - Fever 101 with severe chills beginning in evening of shot - Tylenol broke fever, continued tylenol all next day due to weakness and muscle aches.   Full week later, full body hives with itching - Benedryl broke rash immediately, continued next day and all subsided.
There is no reported issues at the moment but patient requested and  got the first dose of the Moderna COVID-19 EUA Vaccine without telling the Pharmacy that he had also gotten the first dose of the Pfizer-BioNTech COVID-19 EUA Vaccine in April 2021.
case of shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-Dec-2022 Reporter's Comments:  The healthcare professionals reported that the patient received first dose of Shingrix. The patient experienced shingles approximately one month later. The reporter did not consent to follow up.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 06-JUN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Left upper deltoid at injection site; edema, redness, tenderness and very warm to touch.
itchy rash; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received the first dose of bnt162b2 (Pfizer BioNTech, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 22Dec2020 17:45 at a single dose for immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. On 28Dec2020 at 06:00, 6 days after the initial Covid vaccine dose, the patient developed an itchy rash all over her body. Started first thing in the morning with itchy ankles, and by the afternoon, it was covering her whole body in patches and was intensely itchy. No other associated symptoms. No new detergent, clothing, foods, meds to explain. The patient left for work, showered, and took Benadryl. The rash went away and at the time of the report, feels fine. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. The patient has no other vaccine in four weeks. The events resolved on an unspecified date in Dec2020.
This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant therapies were not reported. In 2013, the patient was vaccinated with the first pediatric dose of VAQTA 0.5 ml at the age of 16 years old, then in approximately 2016, the patient was vaccinated with the second pediatric dose of VAQTA 0.5 ml at the age of 19 years old (route, anatomical location, lot number and expiration date were not reported for the above described vaccines). No adverse effects reported. (Drug administered to patient of inappropriate age and inappropriate schedule of drug administration). Additional information has been requested.
none. We are filing this report as part of the regulatory authority requirements because we mistakenly administered the bivalent vaccine when it was the patients' first COVID vaccine and should have been Comirnty.
Classic example of 'Covid Arm' with rash appearing 12 days after receiving shot.
pt recv vax 27SEP97 & pt exp malaise for the next two weeks & on 20OCT97 pt was dx w/diverticulitis;tx consisted of cipro & Flagyl which stopped stomach soreness;later pt c/o feeling of an empty stomach & sinus congestion w/no drip or drain
Started on 4/15/2021.. on my back it felt like bugs were crawling on me. This happened off and on throughout the day everyday. Since the second shot on 5/11/2021  it the bug crawling sensation happens more. Then  on 5/18/2021 I started to get pain in one general area where I actually had a mole removed when I was a young  child (10?) This continued with the crawling bug sensation. On 6/5/2021 a additional feeling started where I get a burning , painful sensation on the area where the mole was removed 48 years ago. Now I have not had any of the sensations prior to the PFIZER shots.
One week after receiving ZOSTAVAX pt noticed "small red spot" under left eye, enlarged under eye, spread to right eye, on nose, left cheek and then down neck to upper chest. Cycles: red/itching --> hard/scaly, then peals and reports. Seen by PCP & given MEDROL Dose Pack - no improvement. Seen by Derm with Dx allergy.
Info has been received from a 74 year old female with no known allergies, a history of prior vaccination with pneumococcal vaccine 23 polyvalent without an adverse reaction and soreness in her arm from an influenza virus vaccination on 10/21/2002 and no prior medical history as per pt report who on 10/23/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #09962-invalid). Concomitant therapy included metoprolol succinate (TOPROL XL TABLETS), atorvastatin calcium (LIPITOR) and paroxetine HCl (PAXIL). The pt reported that on 10/25/2002, she was "quite ill." She was extremely weak and slept much of the time. Her body ached all over. She had swelling of her shoulders, upper arms, and fingers. She also had some red marks on her body. The pt noted, she did not seek medical attention, therefore she had no physician info to provide. Additional info is not expected.
Localized reaction to flu shot. 5:25PM 9/9/09. Swelling at site. Applied ice and observed. Pt had no pain no dizziness no S.O.B. Observed 45 minutes. Called MD. MD prescribed BENADRYL 50mg & told pt to go home. Told pt to go to emerg. room if worse or S.O.B.
Initial information received from a healthcare professional on 02 January 2014. A female patient, whose demographics, medical history and concomitant medications were unknown, had received a dose of influenza vaccine (Manufacturer unknown, batch number, dose number, route and anatomical site of administration unknown) on an unspecified date. On an unspecified date, the patient experienced a bad reaction and developed a cold sore. Laboratory data and corrective medications were unknown. Further details were not available at the time of this report. The patient outcome was unknown. Documents held by sender: None.
Information has been received from a 71 year old female with no pertinent medical history and allergies to sulfonamide and silver nitrate who on 14-DEC-2007 was vaccinated with ZOSTAVAX.  Concomitant therapy included alendronate sodium (FOSAMAX) and an unspecified "acid inhibitor".  On 16-DEC-2007 the patient developed muscle aches on her legs.  At the time of reporting the patient had not yet recovered.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information is not expected.
they have administered 2 doses FLUZONE HIGH DOSE QUADRIVALENT to a patient with no adverse event; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old female patient who received 2 doses INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2022 patient received a 0.7 ml dose 1 of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ875AD, expiration date: 30-Jun-2023) via intramuscular route in the left arm. On 16-Dec-2022, the patient again received 0.7 ml dose 2 of suspect same vaccine (lot number: UJ935AC, Expiration date: 23-Jun-2023) via intramuscular route in the left arm with no adverse event (extra dose administered) (unknown latency).   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event they have administered 2 doses fluzone high dose quadrivalent to a patient with no adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Six hours after receiving the recombinant Zoster vaccine and the pneumococcal polysaccharide vaccine, I developed body aches.  By the next morning, I developed chills and by mid day the following day of administration, I developed a fever (101.5).  Additionally, I had significant soreness at the injections sights (deltoid) on both arms that I received the vaccines.  My left deltoid was swollen and I believe that was the side I had the pneumococcal polysaccharide vaccine.  My right deltoid was sore but less so.  I also had to call in sick for work and I was out of work for two days.  My symptoms resolved 48 hours after receiving the vaccines and I feel healthy now.  I took ibuprofen to control the symptoms.
First Shot April 20th of Moderna after facility cancelled my JJ, Second shot J&J in facility after facility cancelled my second appointment of Moderna. Could not make 2nd shot appointment. Going away for work in state and could not get second shot for three months so just got JJ. 102 fever, chills, chest pains, spasams, joint inflammation, no appetite, no bathroom. full body pain and some altered mental state. weakness. Going on 18 hrs now fever continues to rise.