chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 19 October 2010 from a health care professional, which also involved a case of misuse. A 64-year-old female patient had received an injection of FLUZONE HIGH-DOSE, lot number U3613AA at 12:35 hours (date not reported) and at 15:00 hours (also reported as 3-4 hours after injection), the patient developed shortness of breath (SOB), increase respirations, chest tight, tightness in throat and a sensation of throat swelling (with no physical swelling). The patient presented to the emergency room with an allergic reaction and the course/duration of symptoms was noted to be improving. The patient had no rash, no redness, no itching, not burning, no pain and no streaking redness. It was also noted the patient had no dyspnea, wheezing or swelling and she denied difficulty swallowing, denied chest pain and denied nausea and vomiting. The degree of event onset was moderate, and the degree at the time of evaluation was minimal. Potential allergens were reported as unknown. Risk factors consisted of food allergies. The patient had no history of previous anaphylaxis, asthma or seasonal allergies. "Therapy today" was reported as none. The event duration was not reported; however, the patient's outcome was recovered (date not reported). The reporter for this case is the same as for case number 2010-06036. Documents held by sender: None.
pain in armpit; a knot under left armpit; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain in armpit), AXILLARY MASS (a knot under left armpit) and TENDERNESS (Tenderness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, SPIRONOLACTONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced AXILLARY PAIN (pain in armpit), AXILLARY MASS (a knot under left armpit) and TENDERNESS (Tenderness). The patient was treated with IBUPROFEN at a dose of 3 dosage form every six hours. At the time of the report, AXILLARY PAIN (pain in armpit), AXILLARY MASS (a knot under left armpit) and TENDERNESS (Tenderness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headaches; very pale; no appetite; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN9581, expiry date not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 (at the age of 57 years old) as dose 1, single for covid-19 immunization. Medical history included Barrett's esophagus and have known allergy (unspecified), both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in workplace clinic. In Feb2021, patient had headaches, was very pale and had no appetite.  The events were reported as life threatening and had caused hospitalization on unknown dates in 2021 for 2 days. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events reported which included testing (date unknown in 2021 and unknown results) and patient was put on blood thinners. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
18-hours post-immunization, I got a few hives. I took an over-the-counter allergy medication and it cleared up. 30-hours post-immunization, I got quarter (the coin)-sized hives on most of my body. I've taken Benadryl both orally and topically, and the hives have reduced in size, but are still present all over my body.
Mild SOB with H/A & dizziness. No signs of distress, USS,  h/x of shelfish allergies. Instructed on Epi pen use & Benadryl and being driven home. Pt communicated understanding. Instructed by provider to call 911 in case of emergency. Pt discharged to home, denied SOB, with complaints of slight H/A. BP 121/73; HR 66, RR 16, SpO2 99%
Patient received vaccine in left arm, she then noticed the arm had become red at injection site. 2 days later below injection site a rash developed and began to spread over whole upper arm that was hot to touch, but the patient did not experience fever. She waited a couple days to see if the rash would resolve on its own but it did not so she went to her PCP and a dermatologist who diagnosed a likely cellulitis. Patient was given doxycycline hyclate 100mg tabs PO BID x 7days. Patient had picture of rash on phone which I saw.
Ten days post Moderna booster, scalp and ears began itching / tingling (mid morning). Within 30 minutes, hives on scalp and ears began, lymph nodes on back of neck were swollen and sore. Palms of hands became intensely itchy,  hives began showing up on inner arms and wrists, thighs, stomach, and back. Hive patches seemed to move and became much worse when itched. I started by taking Benadryl. It helped a bit, but not much. Went to general physician one day after onset of symptoms, was told to take antihistamines, no known cause. Daily after the doctor visit, I take 180mg fexofenadine (am), 10mg famotidine (once am, once pm), and 10mg cetirizine (pm). I still have very itchy skin, but no hives. Dermatographia is everywhere, but worse on limbs and stomach. Flares happen in the evening. No other allergies, no difference in product use or foods. Will see allergist / immunologist shortly.
On the day after getting the COVID vaccination, I experienced pain in my left shoulder muscle similar to a flu shot. The pain was so mild that I got the second shot in the same shoulder. I did not mention it earlier because I did not want to dissuade anyone from getting vaccinated or cause undue alarm due to some minor pain. However, after 6 months, the pain persists and appears to be getting worse. Therefore, I feel it should be reported.   I took the second shot on 02/09/2021- Moderna 029K20A.
Moderna vaccine was given without regard to patient having had the Janssen covid vaccine on 3-12-21.    Moderna was given as what the patient viewed as a needed "booster".   There was no adverse effect or event that occurred as a result of the additional covid vaccination.
Pt had come in for Boostrix & fluzone but I administered Shingrix & Fluzone instead as I had pulled the Shingrix for a previous pt. I also administered Boostrix as well and notified her of the error. I sent a message to the provider one hour after the incident, which occurred on Saturday, since the office was closed on the weekend. The pt seemed understanding but I will follow up with her on Monday to check on her and will follow up with the provider
DIARRHEA; TOOK DOSES INAPPROPRIATELY; This spontaneous case report was received from a nurse (PVX2019-072) on 07-Jan-2019. The report describes a 70-year-old elderly female consumer who had diarrhoea following the intake of oral Vivotif for typhoid vaccine. The consumer also "took doses inappropriately".  The consumer's concomitant medication included probiotics. The past medications included Vaxchora (cholera Vaccine Live Oral), Hepatitis A and B and Tdap (tetanus, diphtheria, and pertussis) vaccines, which she received on 17-Dec-2018.  It was reported that the consumer started Vivotif on 26-Dec-2018 and finished it by 02-Jan-2019 and diarrhoea happened about a week after the consumer finished the entire course of Vivotif. She also stated that the consumer did not receive any treatment and she was fine. The reporter further stated that she denies fever, chills or abdominal pain. The consumer took no medications for the events.  The action taken with Vivotif with respect to the events diarrhoea and "took doses inappropriately" was not applicable.  The clinical outcome of the event diarrhoea was resolved while with the event "took doses inappropriately" was unknown.  Company's Comment: In this case, it was reported that 70-year-old adult female consumer had diarrhoea one week after the completion of full course of Vivotif. Her medical history of using probiotics concomitantly suggests some gastrointestinal problem. Diarrhoea is labelled as per CCDS. Hence, in view of the above information the causality of the event with Vivotif is assessed as not related. The causality of the event "took doses inappropriately" with Vivotif was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that 70-year-old adult female consumer had diarrhoea one week after the completion of full course of Vivotif. Her medical history of using probiotics concomitantly suggests some gastrointestinal problem. Diarrhoea is labelled as per CCDS. Hence, in view of the above information the causality of the event with Vivotif is assessed as not related. The causality of the event  "took doses inappropriately" with vivotif was considered as not applicable.
Moderate sized localized reaction that started at the top of her left shoulder down to her elbow. Redness, swelling, itchiness, hot to touch. Started approx 4 hrs after injection.
Pt experienced seizure.  Pt has history of seizures and experienced seizures with both previous vaccines as well. Lasted about 5 minutes.  Pt did not required follow up from medical facility.  She states she had multiple seizures throughout the remainder of the day and is experiencing a low-grade fever today.
Information has been received from a consumer concerning his 16 month old daughter with no past medical history and no known allergies who on 01/28/2002 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 01/28/2002, 3-4 hrs post vaccination, the pt experienced fever of 102, vomiting and diarrhea. Unspecified medical attention was sought. Additional info has been requested.
I had the first dose on 1/06/2021 and the second dose on 1/30/2021.  I had a complete physical (including a normal EKG) with doctor on 2/09/2021.  The next day on 2/10/2021 I went into atrial fibrillation and had to be taken to the hospital.
PATIENT RECEIVED SHOT AT 5:07PM 8/13/20. RECALLS BODY ACHES STARTING AROUND 11PM. STATES WAS IN BED ALL DAY 8/14/20 FEELING ACHY AND TIRED. TOOK ADVIL OTC FOR SYMPTOMS. 8/14/20 IN THE EVENING PT STARTED DEVELOPING ITCHING AND HIVES. 8/15/20 AT 9AM CALLED PHARMACY TO REPORT ALL OVER ITCHING AND HIVES. NO BREATHING ISSUES. AT 1:15PM PATIENT REPORTS SYMPTOMS ARE IMPROVING WITH ALLEGRA AND PREDNISONE 10MG.
Event: Sudden onset blocked eustacean tube (bilateral) and dizziness.  No fever. Otherwise asymptomatic. Treatment: Pseudoephedrine HCL (extended release) 240 mg tablets p.o.  Outcome:  One ear cleared within 48 hours.    Blockage completely resolved within 96 hours.  Dizziness gradually resolved within 7 days.
I experienced fatigue, pain at injection site, and flue-like symptoms the day of the vaccination. Next day flue symptoms lessened but I began experiencing stomach swelling and pain, skin rashes and break outs, nausea and fatigue which did not improve despite taking Prilosec. I took a blood test a month later which revealed elevated levels of GGT, ALT, AST and  indicating liver damage. I did not have medical insurance and could not afford further tests/treatments. I have applied for insurance in order to get more tests and treatment for the liver damage.
This case was reported by a other health professional via call center representative and described the occurrence of atonic seizures in a 7-month-old female patient who received PEDIARIX (batch number 4233K, expiry date 5th September 2016). Concurrent medical conditions included oral candidiasis (child presented at office visit with oral candidiasis - was prescribed Nystatin). Concomitant products included Hib, PREVNAR, nystatin and TYLENOL. On 18th March 2015, the patient received the 2nd dose of PEDIARIX (intramuscular) .5 ml. On 21st March 2015, 3 days after receiving PEDIARIX, the patient experienced atonic seizures (serious criteria disability, life threatening and other), staring, screaming, crying and movements abnormal. On an unknown date, the patient experienced oral intake reduced (serious criteria disability, life threatening and other) and behavior abnormal (serious criteria disability, life threatening and other). The patient was treated with diazepam and phenobarbital. PEDIARIX was discontinued. On an unknown date, the outcome of the atonic seizures, oral intake reduced, behavior abnormal, staring, screaming, crying and movements abnormal were recovering/resolving. It was unknown if the reporter considered the atonic seizures, oral intake reduced, behavior abnormal, staring, screaming, crying and movements abnormal to be related to PEDIARIX. Additional information was provided: The subject's mother had G6P4 and delivered this child at 40 weeks via C-section. Nurse reported that the patient received 2nd dose of PEDIARIX on 18 March 2015 along with PREVNAR and HIB, three days later the child experienced an atonic seizure described as staring in space, screaming and crying and spontaneous head movement. The child continued to have these issues noted per mother at an office visit on 01 May 2015 and even noted post Emergency room visit with this 6 weeks abnormal behaviour. An EEG was ordered, but unclear if that has been completed at time of this call. On 8 July 2015 the child was seen again in physician office and noted to be thriving and doing well. PREVNAR and PENTACEL were given at this visit. The patient was followed by neuro-physician, who recommended holding Pertussis component of vaccines. The child is being managed on diazepam and phenobarbital per nurse. From the visit on 01 May 2015 it also appears the child may have received TOPAMAX, but the nurse was not able to determine a date. The nurse also noted during this call that the child had also experienced chronic food aversion and decreased bottles for over a month.
Consistent random spotting , flesh coming out, cramps, headaches, breast tenderness, exhausted, backaches , dizzy, loss of appetite, swollen veins, chest tightness, heart rate lowered.
First dose July 15 and is 2nd dose still good with it being almost 7 months? Or will I need to do a 3rd dose?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th July 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not received the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient enquired if 2nd dose was still good with it being almost 7 months after the 1st dose or if he/she needed to do a 3rd dose. The follow-up would not be possible as no contact details were available.
pt recv vax 23SEP93 & pt reported started seeing MD for rash MAR94 on neck,scalp,arms,legs,shoulders & back;dx contact dermatitis & tx for itching w/zonolien,folonocide,povidone-iodine,xanax;pt devel open sores on arms & trunk
patient received a dose of Boostrix that expired the day before she was administered it; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On 25-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Boostrix that expired the day before she was administered it).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 26-Sept-2023 The case was received from the registered nurse. The reporter consented to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used.
Fever of 102.5.  Listless and generally acting very sick.  Complained of head and stomach pain.
high fever, dizziness, blacked out, dehydration, vomit, upset stomach, rib pain, stomach pain, body pain;
Complete body aches for 2 days starting the following day Runny nose for 1 day within hours after shot
Was in the hospital 3/8/21 for pyelonephritis with obstructive stone.  Tested COVID + on 3/8/2021.  Remained asympotmatic and was discharged from the hospital on  3/12/2021
This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got a case of the shingles after 2 doses of SHINGRIX. This case was considered as suspected vaccination failure as time to onset for the event was unknown. The reporter agree to follow up from GlaxoSmithKline.
Pfizer 3/6/21, 3/27/21, 10/4/21, 4/1/22, 10/6/22. Positive on 12/14/22
Patient presents with hematoma, slight edema ,redness and itching at injection site Cortisone crean was applied to injection site and it has now resolved
Severe joint pain and fatigue for 9 weeks. After my rheumatologist prescribed a steroid burst in week 8, I got some relief, but even 8 months later I have not returned to normal.
85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not.   "...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)"
Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-333374 (Patient Link).
cold; congested; running nose; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), NASAL CONGESTION (congested) and RHINORRHOEA (running nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), NASAL CONGESTION (congested) and RHINORRHOEA (running nose). At the time of the report, NASOPHARYNGITIS (cold), NASAL CONGESTION (congested) and RHINORRHOEA (running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.  Patient is due for second Moderna shot (near miss-delay).   Reporter did not allow further contact
I also got sick, had a fever and body pain. But I overcame it.; I also got sick, had a fever and body pain. But I overcame it.; I also got sick, had a fever and body pain. But I overcame it.; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the got shingles 9 years ago), blister, infected of face, neck and scalp except eye (it had started inside his/her mouth and went up the right side of his/her face), burning sensation and pruritus. Previously administered products included Cream, Antibiotics and Shingles vaccine. Concurrent medical conditions included pain, hearing decreased and ear discomfort.   On 11th December 2022, the patient received the 2nd dose of Shingles vaccine. On 11th December 2022, less than a day after receiving Shingles vaccine, the patient experienced fever, sickness and general body pain. On an unknown date, the outcome of the fever, sickness and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, sickness and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-DEC-2022 Reporter's comment: This case was reported by the patient via  interactive digital media. The reporter stated that the patient 9 years ago.  It had come in through his/her ear and came out through his/her head halfway down his/her scalp. His/her physician had prescribed an antibiotic and cream to apply to the bags of water that were formed. The reporter stated that was terrible. The burning sensation was like they were burning your face and when the bags start to dry, the itching starts and the pain never goes away.  You could barely sleep. His/Her right ear still bothers him/her after 8 years and his/her hearing had been decreased. At the time of reporting, he/she have had already been vaccinated with two doses. He/She had also fallen sick, had a fever and body pain, but he/she had overcome it.  He/She had been encouraging everyone to get vaccinated because if they did not have had the vaccine, this could happen to them also and for those who had chickenpox as child. Additional supportive information: This case was linked with US2022AMR186394  which was reported by same reporter. Follow-up would not possible, as no contact, details were available. This case - US2022AMR186394  was found to be duplicate of the case - US2022AMR186390.  All the information from  the case - US2022AMR186394 was copied into the case - US2022AMR186390 and the case - US2022AMR186394 was deleted from the database as it was created in error.
Patient came to our pharmacy the day after receiving her flu shot stating that her left arm is red. The arm was warm to the touch but no different than her other arm. Patient also mentioned that her arm feels tender.