chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Muscle pain at the injection site; Swelling; Chills; Headache; Sleepness night; Bit of redness; fever; stomach upset; painful; Muscle pain at the injection site; This case was reported by a consumer and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles at the age of 40).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain. The patient was treated with naproxen (Aleve) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain were unknown.   It was unknown if the reporter considered the fatigue, myalgia, injection site swelling, chills, headache, insomnia, injection site erythema, fever, upset stomach, pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles when the patient was 40, over a few days and it was painful.  The patient did experience some difficult for common symptoms all but fever and stomach upset. The patient experienced amount of fatigue and muscle pain at the injection site and the degree of swelling. The patient was treated with an ice pack that relieved the swelling fairly quickly.  The chills and headache were mild. The patient did use an Aleve for pain after experiencing a sleepless night after the injection.  At the time of reporting the patient had only a bit of redness left that was waning and minor pain at the injection site that did not require use of pain reliever. It was reported that the patient would take the second shot better prepared. The patient stated that the few days of discomfort was far better than the weeks suffered years ago with shingles.
positive COVID test; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID-19  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after administration of the vaccine, the patient developed mild to low moderate symptoms of COVID-19 and tested positive for COVID-19 on 04-JAN-2021. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   Outcome of the event tested positive for COVID-19 was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced a NS unexpected event of COVID-19 with mild to low moderate symptoms of COVID-19. Event onset occurred 6 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fainting, loss of consciousness for 15-20 seconds. Maintained strong pulse, B/P 92/60, O2 SAT 94%.
Shivering, cold, sweating, headache, light (photo) sensitivity, sore injection site, nausea, tired, body ache.
Caller reports vaccine was administered after experiencing temperature excursion. Temperature -11.6C . Time frame  0 hour 30 minutes; No additional AE; This spontaneous report was received on 14-JUN-2022, from a consumer regarding to an infant patient of an unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not provided. Concomitant medication included sterile diluent.  On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection,lot number: U02505, which was an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX), expiration date reported as: 13-AUG-2023 (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported), administered as prophylaxis.   It was stated that on an unspecified date, the suspect vaccine varicella virus vaccine live (oka/merck) (VARIVAX) injection was improperly stored; therefore, it experience a temperature excursion of minus (-) 11.6  degree Celsius (C) for 0 hours, 30 minutes and 0 seconds. There was no previous temperature excursion, and no additional adverse event was reported.
Deltoid area of left arm which received Tdap vaccine began to swell and become very painful, there was mild warmth of the area. After another 10 minutes, patient reported ache in back of neck and mental "cloudiness". Medical attention was not required. She was feeling better after about 3 hours. After one week her left arm is still sore.
local inflammation began approx 15min p/vax;feeling of swelling & tenderness;bright redness 4 1/2" circumference-heat & swelling-by 6APR98 erythema dec to 3 1/2" area w/heat & decreasing swelling;by 8APR98 swelling subsided erythema;tender
This spontaneous report as received from a registered nurse refers to a 16 month old male patient. Patient's historical conditions, current conditions and concomitant medications were unknown. On 30-MAR-2015 the patient was vaccinated with expired (Oka/Merck) VARIVAX lot # J003532, expiry: 25-MAR-2015. No adverse event was reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
This spontaneous report as received from a nurse, concerning to a 18 year old white female patient. Her medical history and concurrent conditions were not reported. On 04-FEB-2016 at 12:30, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies were reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.
On 11/17 I had a horrible feeling of dizziness that overcame me while I was circuit training that lasted until 11/27/2010. My head felt very heavy and the room was spinning and tipping -like I had a bad hangover. For three days I stayed very still - by 11/27 I was sick of feeling sick so I jumped on my treadmill and ran a 5 K to sweat out what ever was making me sick. I do not drink or smoke and am a runner - but I do have a low tolerance for anything that passes the Blood Brain Barrier.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with none of pertinent medical history and drug reactions/allergies. On 31-JUL-2013 the patient was vaccinated with ZOSTAVAX, 1 vial, subcutaneous and had a small blood drop presented on the injection site right after ZOSTAVAX vaccination. Concomitant medication included "high blood pressure and cholesterol medication". No sought medical attention. No treatment was given for AE. None lab diagnostics studies performed. On 31-JUL-2013, the outcome of event was recovered. Additional information has been requested.
Pt recd series of vaxs (20mcg); date of 1st & 2nd doses unspecified; 3rd dose given FEB91; all 3 vaxs were uneventful; as of JUN91 Pt has seroconversion w/o seroprotection; no rx given;
Within 30-minutes of vaccination, the patient reported sudden onset dizziness when they stood up and near-syncope. EMS evaluated the patient on-site. The patient was hypertensive (171/92). EKG performed by EMS demonstrated sinus brady, rate 58bpm, No ST elevation. FSBG: 71mg/dL. EMS administered IV fluids. EMS transported the patient to  Hospital Emergency Department. In the ED, the patient remained hypertensive (159/82). Pertinent lab tests were EKG: NSR, No ST-T changes, no ectopy, normal PR & QRS intervals and CMP/CBC/UA: Unremarkable. During evaluation the patient reported feeling improved and was discharged with diagnoses of dizziness and hypertension.
Hemoglobinuria (PNH); This case was reported by a nurse via call center representative and described the occurrence of paroxysmal nocturnal hemoglobinuria in a male patient who received Men B NVS (Bexsero) for prophylaxis.   In February 2019, the patient received the 1st dose of Bexsero. On an unknown date, 2 weeks after receiving Bexsero, the patient experienced paroxysmal nocturnal hemoglobinuria (serious criteria GSK medically significant). The patient was treated with ravulizumab. On an unknown date, the outcome of the paroxysmal nocturnal hemoglobinuria was unknown.   It was unknown if the reporter considered the paroxysmal nocturnal hemoglobinuria to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. 2 weeks after receiving Bexsero, the patient started receiving infusions of Ravulizumab for hemoglobinuria (PNH).  The patient had been receiving infusions every 2 months.
Patient developed fever and had 4 febrile seizures beginning the morning of October 6th, approximately 15 hours after vaccines were given.  She was first transported to a local ED, where she had another seizure and was given lorazepam.  She was then transported to the hospital via emergency transport and experienced another seizure like episode, was given another benzodiazepine.  she arrived in  ED and had an additional seizure, and was given another dose of ativan.  She was admitted toMed/Surg unit and stayed there for 2 days under observation and an EEG was also performed.
Information has been received from an investigator concerning a patient who on an unspecified date was enrolled in a study. This report was part of a post-marketing surveillance program. It was reported that 8 weeks post vaccination the patient experienced edema/swelling/induration/due. The reporting investigator felt that edema/swelling/induration/due were definitely related to study therapy. Edema/swelling/induration/due were considered to be other important medical events. No further information is available.
After  waiting 15 minutes observation after vaccine as we were walking in the skywalk to the vehicle patient reported her heart was racing.  After sitting for just a few minutes she felt better.
Patient was advised to apply ice and use Tylenol as need basis and follow up with primary care doctor.
Shot 2 at 730 am by noon feeling of nausea and fatigue, injection site pain. 6pm fatigue and chills. 10pm to 3am next day chills, shivering, headache, no fever. Throughout 3/10/21 headache and fatigue.  Stayed in bed and hydrated, two Tylenol for headache.
On 8/29/06 pt woke up in am to rash on face and fever of 103. Rash not itchy. Treatment Tylenol or Motrin for fever. On 8/30/06 Pt continues with rash on face off and on and also fever continues. Temperature ranging 99.2 - . Also complains of headache.
This is a spontaneous report from a contactable consumer (patient's husband) and from the patient's daughter. A 90-year-old male patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date 30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number  49281040188) both via intramuscular route in the arm for immunization on 17Oct2017 14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule every night at bedtime. Relevant medical history included Enlarged prostate since Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever and difficulty breathing. He was taken to the emergency room via an ambulance at 09:00 on 11Nov2017 because of these events. He was admitted into the hospital on 11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She mentioned as treatment of the pneumonia, he was given heavy antibiotics: Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia and blood test showed Pneumonia bacteria in the blood stream. She also mentioned that after the doctor told them that the staff could not do anything else for him, and the patient was near the end of his life, on 16Nov2017 he was transferred to Hospice and given Morphine. Again, this was given as part of his treatment for the end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was done. Reported Cause(s) of Death: drug ineffective; Pneumonia.
Colleague stated she has not previously had a reaction to the influenza vaccination. She expressed her primary physician was comfortable with her receiving the vaccination and that she will stay for the recommended observation time period.15 minutes after receiving vaccination, colleague complained of itching and swelling in her throat, along with a cough. Colleague was escorted to the ED exam room. ED staff was notified. Colleague was treated with Epi, Solumedrol and Benadryl with effective results. Writer followed up with colleague and ED physician. No further issues were noted. Colleague advised by writer to follow up with primary physican, follow ED discharge instructions, notify employee health of any additional reactions. Writer notified Pharmacist Lot #UT7683NA Expiration Date 06/30/2023.
Infanrix instead of boostrix; Patient received an infanrix dose by error; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 11-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's Comment: The reporter reported that a patient received an Infanrix dose by error. The reporter consented to follow up. Additional Supportive Information: The patient received an Infanrix dose by error, which led to accidental overdose and inappropriate age at vaccine administration.
I had a sore arm and that was it initially after receiving the shot. I caught COVID on 11/26/2021. I had body aches, a headache, sinus, and congestion. On 11/29/2021 I went to the local urgent care and I was diagnosed with COVID. I have a follow up appointment on 12/16/2021 to make sure everything is okay. I am almost feeling better now.
Case number PHEH2014US024330, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He had tolerated vaccines (no further details provided) well in the past. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative were updated.
Round elevated red area for 7 days. Painful at touch and feela warm.  Mild headache
- Long term widespread tingling / pins and needle feeling  since date of vaccination (started with numbness in my face)              - this is ongoing, it doesn't hurt, but it's more of an uncomfortable feeling               - A FEW periods of arms and legs becoming numb               - Painful spasms in feet and hands
Extreme pain in calf right leg lasted for approximately six hours. I took one Tylenol 500mg for the pain the night of the event. Next morning the pain was mostly gone. Had residual minor pain all day.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm pain after first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. Concurrent medical conditions included high blood pressure and gout. June 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm pain after first dose). At the time of the report, pain in extremity (arm pain after first dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications included high blood pressure medication and gout medication. Reporter stated her husband had arm pain after first dose. No treatment information provided. This case linked to MOD-2022-539148, MOD-2022-539162 (patient link).
Left arm red warm swollen and itchy from elbow to vaccination site.  Apply warm compress BENADRYL Q 9 hours PRN or ZYRTEC Q 24 hours PRN.
On Thursday morning I noticed a pain where my ear meets my jaw and as the day went on it became more severe, to the point I couldn't open my mouth to eat. The next day my ear was in pain, felt full, started to get swollen, couldn't hear very well out of it. The following day I lost all hearing out of it, it became even more swollen, has been throbbing, can't even see inside my ear. I went to a Clinic on Saturday, the 15th, and they diagnosed me with an ear infection. After 3 doses of an antibiotic, 3 doses of prescribed ear drops, and several days worth of ibuprofen the swelling has only gotten worse with terrible pain.
gets bad side effects from the flu shot; Initial information received on 18-Sep-2023 regarding an unsolicited valid social media non-serious case received from consumer/non-hcp.  This case involves an unknown age female patient who gets bad side effects from the flu shot after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had got bad side effects from the flu shot (immunisation reaction) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gets bad side effects from the flu shot).  At time of reporting, the outcome was Unknown for the event gets bad side effects from the flu shot.
3/21/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Dizziness, patient reports" this always happens to me".   Assessment : Time of assessment 1740pm. Alert and oriented.   Actions taken: 1745pm- Lying on stretcher, VS- BP- 98/73, patient reports is her baseline, P- 81, O2- 99%. At 1810pm- Vs BP 113/64/ P- 72, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/21/2021  5:26 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER2613   NDC: 59267-1000-1          Electronically signed by RN at 3/21/2021  7:55 PM  Immunization on 3/21/2021   Detailed Report  Note shared with patient
pt recv vax 29JUN98 & 29JUN98 pt exp dizziness, nervousness & anxiety to point of agitation w/tremors;also exp diaphoresis & c/o pain in extremities;pt seen in ER & treated w/pred;pt missed 2 days of work from this rxn;
Information has been received from a physician in a published literature article, concerning a 20-year-old male with inflammatory bowel disease, protein-losing enteropathy, hypogammaglobulinemia, and glucose-6-phosphate dehydrogenase deficiency who was receiving multiple immuosuppressants had red eyes and blurry vision for 3 weeks. He was vaccinated with VARIVAX (Merck) 1 month previously. Visual acuity was 20/40 OD and 20/50 OS. Intraocular pressure was 46 mm Hg OD and mm Hg OS. A corneal pseudodendrite was present in the left eye and there were mutton-fat keratic precipitates in each eye. The anterior chamber had 2 + cell OD and 3 + cell OS. There was 2+ vitreous haze in the right eye and occlusive retinal vasculitis involving all 4 quadrants. There was a single focus of retinitis in the left eye, I elise diameter in size temporal to the macula. Authors performed diagnostic vitreous aspiration in the right eye and injected foscamet sodium (2.4 mg) into the vitreous in each eye. The patient developed a rhegmatogenous retinal detachment in the right eye and was treated with plars plana vitrectomy, enclolaser photocoagulation, ganciclovir intravitreal implantation (Yitrasert), and silicone oil fill. By polymerase chain reaction, the vitreous aspirate and core vitrectomy specimens were positive for DNA from the Oka strain of varicella-zoster virus (VZV), the viral strain used in both the VARIVAX (Merck) and ZOSTAVAX vaccines. The authors read with interest a recent article describing 2 cases of acute retinal necrosis following vaccination with ZOSTAVAX and wish to share author's own experience wit zoster retinitis following vaccination with VARIVAX (Merck). Author's case was unique, however, in that the authors identified the vaccine strain of the virus (Oka) in the vitreous of the involved eye. Both vaccines, however, contained the Oka strain of live attenuated VZV. One of the patients described by the author and colleagues was introgenically immunosuppressed, as was author's patient (in the case reported by the author and colleagues, it was for renal transplantation; in author's case, it was for an inflammatory gastroenteropathy). The complicated rate of retinitis following immunization with VZV vaccination is rare. To author's knowledge, this is the first case that describes the same strain of VZV that is used in a vaccination campaign. Upon internal review necrotising retinitis was considered to be an other important medical event. Additional information has been requested.