chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. From 20-APR-2015 to 29-APR-2015, GARDASIL (lot # K009482, expiration dates: 06-MAR-2017) was improperly exposed to 26F for about 216 hours. On an unknown date in 2015, unspecified number of patients might receive (dose, route of administration and anatomical location was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Papules, macules scattered papules to face back, no vesicles but small head to center Petechiae to left neck.
I woke up with pain in the chest and numb left arm three days after the first Moderna shot. I went to the ER. I had an Irregular EKG and Elevated Troponin levels. I was held at the hospital for 34 hours. I was prescribed colchocine and ibuprofen and pantaprazole to reduce swelling in my heart and pericardium. I have been not excercising and been going to a cardiologist.
Day after: dizziness, chills, hot flashes, fever, fatigue 2 days post: burning and numbness of right ear, right cheek and right side of nose Day 3 post: vertigo and nausea
This morning when I woke up I had a slight headache on the back of my right side. I felt a wave within and my heart rate rose. I was really hungry and ate 3 or 4 bananas. I started to feel uneasy and felt tightness in my chest and pain below the injection site. My heart rate rose into the 100s. Normal RHR= 47-55. I was burping small burps. I was worried and started looking up ERs and contacting family. This event of immense amount tightness and uneasy feeling that lasted about 30-45. Temp was 99.4 then dropped to normal. I thought I was having a heart attack. I called my sister and my symptoms waned. I have had several "cycles" though out the day of feeling very uneasy and slight chest discomfort, but nothing on the level of this morning, or enough to make me go to the ER. It does seem that why I lay down or bend over when sitting down there is discomfort in my chest and I feel uneasy.
Information has been received from a nurse practitioner, for the Pregnancy Registry for Gardasil, concerning a 25 year old female with a history of one previous pregnancy and a miscarriage and a history of childhood epilepsy who on 12-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # 657868/0523U) 0.5 mL IM. Concomitant medications included prenatal vitamins daily (unspecified) as a supplement and ZANTAC daily for reflux. The patient received her first dose of Gardasil IM and since found out that she is pregnant. The nurse practitioner mentioned the pregnancy is normal to date. Medical attention was sought. No additional information is available. The last menstrual period (LMP) was 16-MAY-2007 and the estimated time of delivery is 07-FEB-2008. Follow-up information was received. Medical history and dates of LMP and estimated date of delivery was updated. Follow-up information was received from the physician's office. On 10-SEP-2007 there was a quad screen performed and was within normal limits. On 30-JAN-2008 the patient had a normal healthy baby girl weighing 8 pounds 1 ounce. The apgar score was 9/9. The patient was 38 and 6/7 weeks from LMP. During labor/delivery the baby was in a frank breech presentation and c-section was done. Upon internal review c-section for breech presentation was considered to be an other medical event. Additional information is not expected.
The patient came in 14 days after his first dose of the Pfizer Covid vaccine to receive his second dose. We did not use the Immunization Selection Tool provided by pharmacy to determine that he was 7 days early for his second dose and the dose was given. The patient did not have and has not had any adverse reactions after receiving his second dose 7 days early.
This spontaneous report as received from a Doctor of pharmacist refers to a female patient of unknown age. In approximately July 2012, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient developed injection site reaction described as redness and rash at the injection site about 4 or 5 weeks ago in approximately July 2012. The injection site reaction and rash was reported to have developed about a day after vaccinations with ZOSTAVAX. The injection site reaction and rash was treated with cold compresses and ADVIL and resolved after an unspecified number of days. No other information was reported. Additional information has been requested. This is one of several reports from the same source.
Pt was given KINRIX. This vaccine is not for a 2 month old. Manufacturer was called. No harm to child.
After receiving 4 vaccines, patient felt dizzy, chest presser, headache, sweat  and nausea. Patient had to lay down for about 30 seconds and after 15 mins was able to sit-up.
received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 1 June 2022 Reporter's comment: Medical Assistant reported that patient received Infanrix expired vaccine. The reporter consented to follow up by email. Additional Supportive Information: The patient received expired dose of Infanrix which led to expired vaccine used.
Baseball-sized redness with itching at the injection site, not raised. Reaction has been ongoing for 3 days. Pt will try compress and anti-itch creams.
Covid vaccine monitoring documentation. PT admission 4/7/22 - 4/11/22. 02/11/2021 PFIZER, INC EM9809. 01/21/2021 PFIZER, INC EL9261. 10/05/2021 PFIZER, INC 301308A .04/02/2022 PFIZER, INC FJ9943
pt recv vax; mom states pt cont to cry p/ inject which was given at approx 10am; time at present 3:30pm, site swollen;
painful blistering rash/ shingles; multiple strokes; vision issues; hearing issues; balance issue; kidney injury; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 21-OCT-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced painful blistering rash, shingles, multiple strokes, vision issues, hearing issues, balance issue and kidney injury. The outcome of the events was unknown.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of strokes and kidney injury were considered to be medically significant.
Fever; difficulty breathing; fast heartbeat; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 12:30 at single dose on the left arm for COVID-19 immunization. Medical history included allergies: PCN. Concomitant medications included galcanezumab (EMGALITY) received in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 09Jan2021 18:00, the patient experienced fever, difficulty breathing, fast heartbeat. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.  Information about Lot/batch number has been requested.
ADULT OBSTRUCTIVE SLEEP APNEA 3/13/2022 &  4/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
warm around injection site; swollen around injection site; red around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm around injection site), VACCINATION SITE SWELLING (swollen around injection site) and VACCINATION SITE ERYTHEMA (red around injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (warm around injection site), VACCINATION SITE SWELLING (swollen around injection site) and VACCINATION SITE ERYTHEMA (red around injection site). In February 2021, VACCINATION SITE WARMTH (warm around injection site), VACCINATION SITE SWELLING (swollen around injection site) and VACCINATION SITE ERYTHEMA (red around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include antibiotics.Concomitant medications are not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile. Vaccination site swelling and vaccination site erythema  are consistent with the product safety profile
The patient signed up for a shingles vaccine, second dose. He believed he was receiving the second shingles vaccine, but was given a covid-19 pfizer vaccine dose, 0.3 mL in L arm. Patient realized yesterday 11/4/22 as he was looking at his documentation that he was not given Shingles dose #2. He came into the clinic today to report this error and to receive his shingles vaccine. He reports after the pfizer vaccine, he had fatigue and a sore arm for a few days-1 week. No difficulty breathing, rash, chest pain.
I developed a DVT in my lower left leg, which I noticed from the swelling, warmth and pain. Then, a few days later, on a Sunday so my Dr's office was closed, I started having extreme difficulty in my breathing. I went to the ER and, after having multiple testing, was diagnosed with the DVT and a PE in each lung (almost to the point of full blockage). I was kept in the hospital overnight so they could monitor my breathing to be sure I wasn't stopping breathing throughout the night. I'm now on blood thinners for life.
Patient broke out in hives approximately 2 hours after vaccine administration.  Had hives on torso & neck.  Also complained of a sore throat, but had that complaint off and on for 3 days prior.  Patient's doctor notified, Benadryl to be given at home.
pt recvd 3 does of Engerix-B; titer report dated 20DEC91 indicated pt did not respond;
Information has been received from a female consumer stating that she refused to give her children the MMR II because three male children that she knows developed autism immediately after they were given the shot. One case concerned a 6 year old male pt who was vaccinated with a dose of MMR II vaccine live. It was unknown if there were any concomitant medications, or if the pt had any past medical history or allergies. Subsequently, the pt developed autism. The three boys were six, four (WAES0206USA01826) and two (WAES0206USA01827) years of age. It was reported that they had always been very cognitive and always made eye contact. The reporter noted that "ever since they were given the shot, they developed autism." The pt's autism persisted. It was unknown if medical attention was sought. No other info was provided. Upon internal review, autism was determined to be an other important medical event. Additional info has been requested. Follow up info received from a registered nurse indicated that she did not recall any male children in her practice that had received the MMR II vaccination and then were diagnosed with autism. She could not provide any additional info. *Add'l follow up info received indicated that the MD's office was "unable to assist at this time due to no PT name."* Upon internal review, autism was determined to be an other important medical event (OMIC). No further info is available.
pt called 9MAY95 950am w/ c/o redness of skin @ inj site & itchiness-size of redness of skin about 2-3cm in diameter;
rash; Chills; Fatigue; Sharp pains in back of legs/shooting pain on the legs; Shingles; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID- 19 VACCINE), via an unspecified route of administration, administered in left arm on 05Feb2021 14:00 (Batch/Lot Number: EL3249) at the age of 74 years old as 1st dose, single for COVID-19 immunization. Medical history included ulcerative colitis (autoimmune disease) and high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included sulfasalazine (AZULFIDINE), hydrochlorothiazide and nadolol, all taken for unspecified indications, start and stop dates were not reported. The patient previously took cipro and sulfa antibiotics and had known allergies. The patient got her first dose on 05Feb2021. She stated that she had side effects the next day (on 06Feb2021) including chills, fatigue, and sharp pains down her legs, shooting pain on the legs after a few hours (as reported). She stated that 4-5 days later (on Feb2021), she had a pretty severe case of shingles. The patient would like to know if the shingles could have been a possible side effect or a coincidence since her doctor couldn't answer that. Her real question was if she should get the second dose while she has shingles as she already missed her second dose appointment because she was still recovering, and she still has a rash (unknown date), but she was past due for her second shot. Patient was advised not to get the 2nd dose of the PFIZER-BIONTECH COVID- 19 VACCINE until she recovered from shingles. Events resulted in Emergency room/department or urgent care and therapeutic measures were taken. Outcome of events were recovering. The case was assessed by the reporter as not serious.  No follow-up attempts are needed. No further information is expected.
Left subclavicular fullness; Left subclavicular fullness, very painful; Left subclavicular fullness, very painful, rash, redness; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 (Lot Number: EW0165) as single dose for covid-19 immunisation.  Medical history included Hpylori (H.pylori gastrointestinal disease).The patient did not have known allergies. There were no concomitant medications as the patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 lot number EW0150 on 09Apr2021 at left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced Left subclavicular fullness, very painful, rash, redness on 30Apr2021 20:00 with outcome of not recovered. Therapeutic measures were taken as a result of all the events including antibiotics. The events resulted in "Emergency room/department or urgent care" and "Doctor or other healthcare professional office/clinic visit". The patient was not hospitalized.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse via company representative referring to a female patient of unknown age who on 08-MAY-2013, was vaccinated with second dose of PNEUMOVAX 23 (lot # H017759, expiration date 04-JUL-2014). On 22-MAY-2013, the patient developed pneumonia. The outcome of pneumonia was unknown. Additional information has been requested.
vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol  Pt contacted and no adverse reaction, pt states no problems
Patient fainted within seconds of influenza vaccination. Patient's entire body seized for about 10 seconds. Patient was unconscious for two to three minutes. Pharmacists kept patient seated on floor once he regained consciousness. Emergency Paramedics were called and patient was taken to a local hospital. Patient was awake and speaking when paramedics arrived to the scene.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Pt was sitting on chair in the observation area and he fell over hitting his head on the side panel.  Pt got up immediately and sat back on the chair.  Pt was pale but allert and responsive.  After drinking some water and extended observation time, pt was able to walk away.  EMT was called but pt refused service.
This spontaneous report was received regarding a 65 year old male patient. On 29-DEC-2012, the patient was vaccinated with one dose of ZOSTAVAX, (lot number, expiration date and route was not reported) on the left arm. The patient had no drug reactions or allergies. Concomitant medications included blood pressure medicine. On 30-DEC-2012, the patient had discomfort in her arm on the injection site mostly itching and irritation. There was no treatment rendered for the events. The outcome of the events were unknown at the time of this report.The patient did not seek medical attention. Additional information is not expected.
1/14-8/3/09. Large local reaction lasting 2 weeks, sick 2 1/2 weeks with N+V, temp 99-100.8, terrible H/A, back pain. This was followed by polyneuralgia both feet. Seen by neurologist, Podiatrist, pain management. Lower body reflexes now absent. Episodes severe body pain and migraines. 7/31/09-records received with VAERS report-neurology consult 6/15/09-Painful paresthesias affecting both feet. Status post foot injections without relief. Electrical sensations in both feet especially the great toes. Balance is poor.
redness and achiness at the injection site, Sometimes the achiness goes down his fingers but is mostly in the upper part of arm; redness and achiness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received Shingrix (intramuscular). In March 2019, 2 days after receiving Shingrix, the patient experienced injection site redness. In April 2019, the patient experienced pain in arm. On an unknown date, the outcome of the injection site redness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site redness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient received the Shingrix vaccine about 6 weeks ago before the date of reporting.  A couple of days after receiving the vaccine, the patient developed redness and achiness at the injection site. This lasted about 2 to 2.5 weeks before resolving.  A week before the date of reporting, the achiness returned and had lasted for 1 to 1.5 weeks. Sometimes the achiness went down to his fingers, but it was mostly in the upper part of his arm. The patient provided the consent to follow up.
I tested positive for Covid-19. I had a severe sore throat. I was prescribed Magic Oral Suspension (CMP) mouthwash as treatment.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 02-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
3/26: Headache about 2 hours after administration. and my face turned bright red and hot.  3/26 evening:  I experienced chills, body aches, fever, light chest congestion, fatigue, nausea. Influenza-type symptoms.  3/27: I felt terrible-ran a fever all day of 99.9 - 99.5.  3/28 morning: felt much better.