chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age. On 18-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date in MAR-2013, the patient developed a wheal at injection site after ZOSTAVAX was administered. The outcome of the event was unknown. The patient sought medical attention. Additional information has been requested.
2-3 days post injection arm had a whelp on it, became "black and blue". This spread down to the elbow and the inside and outside of the arm.  Saw MD and was given Cortisone shot. Now states she has asthma, COPD, GERD, and feels tired since vaccine.Also states she had an anaphlactic reaction and had a number of hive outbreaks. Saw Dr. He stated he wasn't sure what caused the reaction but she is sure it is from the vaccine.
pt recvd vax; pt was fussy(crying); pt turned "white"; tongue sticking out of mouth doing rhythmical twisting movements; pt sounded very weak when crying;
mistakenly given an Adacel vaccination instead of Daptacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00721986).  This case involves an 18-month-old female patient who mistakenly given a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination, family history and concomitant medications were not provided.  On 12-Aug-2021, the patient mistakenly received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5757AA, 22-Jul-2022] via an intramuscular route at the right thigh for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number, expiry date and other dosing details not applicable] (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered to patient.  It was reported that, "caller asked if it was alright to administer the DAPTACEL or if the ADACEL would be sufficient. Caller also asked if there is anything that she should be watching for with regard to administering the incorrect vaccine".  At the time of report, no adverse event was reported.  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. 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.
vaccine given on 04/24/2023 pt waited in clinic for 15 min after vaccine was administered by ,CMA -Vaccine Adm was not the correct dose for booster Bivalent. 05/08/2023 T/C with mom and explained that patient was administered a lower Moderna dose than the CDC recommends. Recommendation is to have this dose re-peated appt schedule on 05/25/2023 for booster vaccine. Mom reports patient doing fine and no concerns or reactions after vaccines.
RSV given for indication of rash; Rash; This non-serious case was reported by a other health professional and described the occurrence of rash in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (expiry date OCT-2023) for prophylaxis.   On an unknown date, the patient received RSV vaccine .5 ml. On 18-OCT-2023, an unknown time after receiving RSV vaccine, the patient experienced rash (Verbatim: Rash). On an unknown date, the patient experienced drug use for unapproved indication (Verbatim: RSV given for indication of rash). The outcome of the rash was resolving and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the rash to be related to RSV vaccine.   It was unknown if the company considered the rash to be related to RSV vaccine.   Additional Information: GSK receipt Date: 19-OCT-2023 This report was submitted via the online direct entry reporting system.  The symptoms were not treated. The RSV vaccine was given for the indication of rash, which led to drug use for unapproved indication.
Pt developed unstable angina and cardiac cath done and found 4 of 5 of his previous bypass grafts to be occluded one year after surgery
pt recv vax & suffered a needle stick & presented to ER;MD reported that blood work was positive for either anti-HBc or anti-HBe;no further details were provided;
Diarrhea; Fever; Headaches; Body aches; A spontaneous report was received from a healthcare professional concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, headache, body ache/myalgia, diarrhea.  The patient's medical history was not provided. Concomitant medications reported included histamine, zincoxide, aluminum hydroxide, apixaban, ondansetron, hydroxychloroquine sulphate, lithium, prednisone, nalidixic acid, omeprazole, cimetidine, montelukast sodium, albuterol, diphenhydramine hydrochloride, sertraline, ipratropium bromide-albuterol, adalimumab, pregabalin, hydralazine, roquinimex, fluticasone furoate, potassium, tizanidine products used for unknown indication.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the patient experienced the events, fever, headache, body ache/myalgia, diarrhea . Treatment for the events included paracetamol. Body temperature was 100-101.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fever, headache, body ache/myalgia, diarrhea, were considered not resolved.
Information has been received from a pharmacist concerning a patient who on an unknown date was vaccinated with ZOSTER . The pharmacists reported that on an unknown date the patient developed a rash and shingles after vaccination with ZOSTER. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was "very ill for 3 months". No further information is available. Information has been received from a pharmacist concerning a 71 years old male patient who on 21-SEP-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) abdominal, intramuscularly. Concomitant medication includes a 13th dose of influenza virus vaccine (Glaxosmithkline), intramuscularly int o the left deltoid on 23-SEP-2008. The pharmacist reported that on 24-SEP-2008 the patient developed a rash and shingles after vaccination with ZOSTAVAX. The pharmacist reported that the patient was the friend of the friend of other patient. The person who developed shingles was "very ill for 3 months". Follow-up information received on 08-JAN-2009 stated that the patient developed localized breakout of rash and shingles with discoloration of skin. The patient recovered in 10 - to 14 days. The recovery date was reported to be 14-OCT-2008. No further information is available.
temporary paralysis of both legs , lasting roughly 15 minutes, also headache, dizziness and weakness of limbs
Moderna booster was given to soon, pt was not due for it until 8/25/22, spoke to pts PCP that reassured that pt will be okay just to notify about the incident, called pt and informed her about incident, pt understood and had no questions
Patient lost consciousness. HR and blood pressure were really low. patient was sweating profusely. Patient complained of being dizziness upon regaining consciousness. EMS was called. Patient drank some water and orange juice and began to become more alert and oriented. Patient declined medical transport and walked out of pharmacy with his mother.
Patient fainted approximately 10 minutes after receiving dose 1 of Pfizer covid vaccine LOT ER2613  on 4/1/21. She hit her head on the desk in the room.  This was unwitnessed by any staff member. There were no bumps or open areas on patients head.  Patient was immediately alert and oriented upon assessment when writer walked into room. After assessment advised patient she should go to the ED for further evaluation.  Patient called her mom to come take her to the ED. Further follow up documents patient was not seen in ED.
Patient fully vaccinated with 2 doses of Pfizer (3/8/21 and 2/17/21). Hospitalized with COVID19 infection on 11/30/21
tachycardia @ 126, shortness of beath, dizziness and lightheadedness shortly after injection, then progressed to nausea, vomiting, diaphoresis, palpitations, chest pain, and pain between shoulder blades by 10 am the next morning , patient was sent the the ER for cardiac work up due to high risk of HTN and DMT2
Headache, high fever, fatigue, body aches, chills, nausea Started with headache on first day post vaccine Fever and other symptoms started on 2nd day post vaccine Only ibuprofen and rest given at this time.
By evening I began to feel a little ill scratchy throat runny nose sneezing headache. Then i got a stomach ache and cramps. These symptoms are still present today 5/13/22. my mother age 94 also had the symptoms but from Tuesday 5/10/22 thru today but mild today. mine are still not so good.
Poor Sleep; Headache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache) and POOR QUALITY SLEEP (Poor Sleep) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 08-Jan-2021, the patient experienced HEADACHE (Headache) and POOR QUALITY SLEEP (Poor Sleep). On 07-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, HEADACHE (Headache) and POOR QUALITY SLEEP (Poor Sleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included glucose, potassium citrate, sodium chloride.   Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.; Reporter's Comments: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.
Experienced Crohn's type symptoms subsequent to both vaccinations. Primary symptoms included blood in stool and constipation. No treatment was given after 1st vaccine and symptoms were starting to subside after 3 weeks just before 2nd dose. After second dose, symptoms immediately and started course of Prednisone 20mg/day as treatment tapering off over 3 weeks. Prednisone relieved symptoms within 3 days.
hearing loss; severe ringing in my left ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hearing loss and severe ringing in left ear on an unspecified date. Hours after receiving the first Covid vaccine, the patient had severe ringing in left ear, same side the patient had the injection. Now, patient had hearing loss in that ear. Patient had been advised by an ENT and GP medical doctor to not receive second vaccine. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
patient states feeling immediate pain at injection, more than just a "pinch.' She states making a noise when the vaccine was administered. Patient reported the adverse reaction to the pharmacy 10/15/21, and states that her arm is still sore and difficult to lift two weeks after the injection. she states that she has an appointment with her MD for follow up in the next few days.
shaking chills -severe X 15 hours, then intermittantly- day 1; Rt side crushing chest pain, Lt side extreme squeezing & twisting sensation of heart; intense bone pain in areas that were injured 15 years prior- neck, posterior thorax, sacral area- all on right side only- day 2; awoke day 3 drenched, extreme diaphoreses- loss of 4 lbs; others less intense- loss appetite & thirst, Rt side only parietal and also occipital headache; tired & weak. Ended in 7 days.
the patient has not had any symptoms/ no additional AE; PEDVAXHIB and ROTATEQ were administered to 1 patient after the excursion; This spontaneous report was received from an office manager (in charge of vaccine storage) referred to a 4-month-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had temperature excursion on 11-SEP-2023. The temperature was 47.5 F with time frame: 1 Hour 45 Minutes 0 Seconds. There was no previous temperature excursion. On an unknown date in September 2023, after the excursion, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot #X003664, expiration date: 10-NOV-2025, administered as prophylaxis (strength, and route of administration were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1965641, expiration date: 19-SEP-2024, administered as prophylaxis (strength, and route of administration were not provided) (Product storage error). The patient has not had any symptoms. The reporter stated we did not have permission to contact the patient's physician but did provide permission to follow up with her (the reporter). No additional adverse event was reported (no adverse event).
1st dose on 2020. Late 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (received 1st dose on 23rd December 2020).   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 patient received 1st dose and no reactions reported. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. Note: It was unknown if the patient received 2nd dose or not, so the case was conservatively kept valid for incomplete course of vaccination and query was raised.
Pt recvd 2nd dose of Hep B vax & pt devel pruritic rash on face, arms, shoulders, & chest; tx DPH which helped to relieve itching but not the rash; 3 to 4 months later sx cont to persist;
This patient received a dose of Janssen on 04/02/2021, then received a booster Pfizer dose on 06/29/21 from a pharmacy facility. Pharmacy then provided a second Pfizer dose on 07/20/21. Then on 12/07/21, CDC administered a Janssen dose. The patient has been contacted and has been advised to not receive any more COVID-19 doses at this time.
Extreme fatigue. Redness of eyes. Body chills. Shaking. Headache. Symptoms self resolved over the course of 2 days.
Approximately 2 days after administration of vaccines, pt began to develop blurry vision, which progressed to diplopia, and inability to move left eye. Also progressively began having balance/gait disturbances, nausea, oral muscle weakness, arm weakness, difficulty swallowing. Visual disturbance progressed to rt. eye. Final diagnosis: Myasthenia Gravis.
constant headache and intermittent nausea, beginning 3 days after the vaccine and continuing for 1 week
11/7/07 FluMist given to 20 month old - No adverse effects known at this time.
After the vaccine, I began to start noticing significantly more inflammation than I normal encounter.  I have a history of OI and have had multiple fractures prior to puberty and soft tissue injuries.  These issues became noticeably more intense.  Over the preceding year I had been exercising regularly, gotten weight under control, blood pressure medication had to be reduced and was taking only 1 75mg diclofenac sodium once a day and not even every day.  As the inflammation progressed mobility became challenging and I had to increase the Diclofenac to 2 tablets a day and was frequently adding tramadol one or twice a day as well.  This was just to remain mobile.  I have recovered to the degree that I am now exercising again but with far less intensity and frequency than before.   The aftermath of exercise now is significantly more intense than ever before.  So the accurate answer to #20 is no but improving.  Although I didn't specifically visit the doctor for this.  I increased the dosages of already prescribed medications up to their limits to cope with the pain and inflammation.
Severe pain to left arm site of injection, now going on 4 days.  Low grade fever. Mild nausea. Dizziness.  Chills and shaking.  Moderate Sweating. Felt like flu symptons. Have done flu shots for many years and never experienced this level of problems.
Itching, burning stinging sensation at site of shingles vaccine (left arm) started occurring 7 days after vaccine administration.
This case was reported by a physician via sales rep and described the occurrence of compartment syndrome in a 16-year-old female patient who received BEXSERO. Co-suspect products included Flu seasonal TIV Dresden. In October 2016, the patient received the 1st dose of BEXSERO (intramuscular) and the 1st dose of Influenza vaccine unspecified (intramuscular). In October 2016, less than a month after receiving BEXSERO and Influenza vaccine unspecified, the patient experienced compartment syndrome (serious criteria GSK medically significant), swelling, labeled drug-drug interaction medication error and vaccine administered at inappropriate site. BEXSERO was discontinued. In October 2016, the outcome of the swelling was recovered/resolved. On an unknown date, the outcome of the compartment syndrome, labeled drug-drug interaction medication error and vaccine administered at inappropriate site were unknown. The reporter considered the compartment syndrome and swelling to be probably related to BEXSERO and Influenza vaccine unspecified. Additional details were reported as follows: The patient received both BEXSERO and a influenza vaccine unspecified in the same deltoid muscle, which led to vaccine administered at inappropriate site and labeled drug-drug interaction medication error. These injections occurred two weeks before reporting date. The patient experienced severe swelling and was seen at the local emergency department. The emergency room physician was concerned about compartment syndrome and computerized tomogram was performed but the results were unknown. It was also noted the patient's mother was a nurse. The swelling was resolved at the reporting time, but when it was resolved was unknown. The BEXSERO was discontinued at this time, so the series would not be completed. The brand of flu vaccine was not known by the sales representative at the time of this report.
This case was reported by a healthcare professional (nurse) and described the occurrence of rash in a  54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. Concurrent vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; intradermal; unknown given in January 2012. On February 2012 and January 2012 the subject received 2nd dose and 1st dose of TWINRIX (1 ml, unknown route, right arm). Less than one month after vaccination with dose 1 of TWINRIX, less than one year after vaccination with dose 2 of TWINRIX, the subject experienced rash. According to the nurse, the subject reported that he experienced a rash after his first two doses of TWINRIX. At the time of reporting the outcome of the events was unspecified.
Patient went to ED for possible seizure. He had an episode of hypothermia, cyanosis and abnormal eye movements...possible first time seizure. ED recommended outpatient Neuro. f/u. Appt. for EEG and referral sent to Neuro.
Right thigh slightly warm to touch; nontender nonmovable; slightly red with blanching rash on back of thigh.  Diagnosed with local reaction to DTAP; Benadryl every 6 hours, to call MD if worsens.
Information has been received from a physician concerning a female patient who in July 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) for HPV prevention. The physician reported that the patient was experiencing persistent arm pain, "shooting pains in the shoulder" for about a month after receiving her first dose of HPV vaccine in July 2008. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
At first I didn't feel much. Then a month later I felt like I had a stroke as I was getting up from my chair. I did not go to the doctors until I went to my primary doctor.
I received my 1st vaccine on Friday  May  14 and I felt worse than when I had Covid back in November. My fever was spiking and holding between 100 and 101 since Saturday along with my whole body hurt and  armpits swollen-lymph nodes. Monday my stomach started hurting and had diarrhea Fever was back to 99 but still felt icky tired weird until Tuesday. Wednesday May 19th I  felt a lot better but still not 100% still feeling a bit weird head feels weird and my lymph nodes are still a little enlarged( armpit also)  Had about a week of not feeling bad and then May 27th  I got a sore throat headache stuffed up tired.. by Wednesday June 2nd  my neck lymph nodes was swollen and sore  went in for strep/Covid test both negative . They gave me a antibiotic it?s helping a little throat not as sore and lymph not as swollen But my head still feels weird (kinda dizzy and off) like after my shot  so I don?t k is if it is another flare up from the vaccine or not and  I was supposed to get my second dose today June 4 but I canceled and rescheduled it but I?m nervous to get it in case all of this is from the initial shot
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.